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Coyote Bioscience Portable Zika Test Deployed in Chinese Airports as Firm Develops MDx Pipeline – 10/19/16
The Chinese firm is also developing a menu of extraction-free molecular diagnostic tests using a proprietary "one-step" reagent.
In-Gel 'Virtual Microfluidics' Method Promises Alternative for Single-Cell Analysis – 10/18/16
The method, developed by researchers at MIT, uses a hydrogel to immobilize and separate cells or molecules from each other while still enabling reagent flow.
Researchers at Brown Discover RNA Ligase That Functions at High Temperatures – 10/14/16
The researchers used the ligase to detect Ebola transcripts and suggest it could be applied to in vitro diagnostics and sequencing.
Sandia Lab Creates Quadraplex Immunoassay on SpinDx System, Developing Isothermal MDx – 10/10/16
The portable system uses centrifugal microfluidics, with molecular tests deploying a visualization method that obviates the need for sample prep.
Lynntech Wins Phase II SBIR Grant for POC Dengue MDx Using Convective RT-PCR – 10/6/16
The College Station, Texas-based firm is developing a multiplex, one-step system to diagnose all four dengue serotypes.
Quantitative PCR Gives New Insights on Large Study of Childhood Diarrhea in Africa, Asia – 10/5/16
Researchers implemented qPCR on TaqMan Array Cards to find six pathogens are responsible for up to 90 percent of childhood diarrhea at seven sites in Africa and Asia.
Oncgnostics Garners €1M to Support Clinical Trials of Epigenetic Cervical Cancer Test – 10/3/16
The firm is also pursuing ovarian cancer screening and head and neck cancer tests using methylation-specific PCR.
Innogenomics Launches Forensic Kits Based on Retrotransposable Element Detection; Eyes Liquid Biopsy – 9/28/16
The New Orleans firm launched two products last week for DNA quantification and typing of forensics samples.
UCSF Group Wins NHGRI Funds to Develop High-Throughput Single Cell Digital Sequencing Methods – 9/26/16
The funding supports development of biochemistry and microfluidics for digital droplet multiple displacement amplification.
UPenn Engineers Develop Instrument-Free Zika MDx, Immunoassay – 9/20/16
The device, which will be tested in collaboration with a Panamanian research institute, will run 40-minute tests without the need for electricity.
NYU Team to Validate ddPCR Liquid Biopsy for Monitoring Metastatic Melanoma Recurrence – 9/15/16
Researchers are using Bio-Rad's droplet digital PCR technology to validate seven ctDNA biomarkers that may predict melanoma recurrence.
Startup FluxErgy Developing Portable Microfluidic Diagnostics System – 9/14/16
The company has built a small and rugged system boasting 20-minute qPCR reactions and plans to expand the platform for other types of diagnostics.
Hologic Readying Add-On Module, Respiratory Viral Panels for Panther MDx System – 9/8/16
The new platform, called Fusion, is an addition to the Panther system and will run qPCR assays with three "mini panels" currently in the works.
Roche's POC Molecular Flu Test Shows Advantages Over Alere in Head-to-Head Study – 9/7/16
The Alere flu test detected fewer cases of influenza A in a recent study, which researchers attributed to low viral loads.
GenePOC Gets Additional Debiopharm Investment, On Track for Launch of Spinning Disk PCR Platform – 9/1/16
The investment is the second for GenePOC from the Swiss pharmaceutical company, which will also now also manufacture GenePOC consumables in Europe.
As Biocartis Builds Oncology Pipeline, Its Tests Prove Fast and Accurate in New Evaluations – 8/31/16
Assessments of the firm's rapid molecular BRAF and EGFR tests by researchers in Italy and South Korea showed high sensitivity and a fast turnaround time.
New Fragile X Assays From NIH Could Reduce Testing Cost, Improve Sensitivity – 8/12/16
A suite of assays published today in The Journal of Molecular Diagnostics tackles issues with genetic testing, making it more robust and affordable.
TTP Introduces Point-of-Care MDx Platform Targeting Assay Developers – 8/10/16
The UK-based engineering consultancy has developed a small, lightweight platform that can run PCR assays in 7 seconds per cycle.
Startup Enable Biosciences Wins SBIR Funds to Commercialize PCR-Based Antibody Detection – 8/9/16
The core technology uses proximity-ligated amplification and the firm will build it into tests for type I diabetes as well as highly multiplexed assays.
Spartan Bioscience Targeting Alzheimer's Drug Trials With New Near-Patient APOE Test – 7/27/16
The firm launched the multiplex PCR-based test this week on its Spartan Cube platform to support patient enrollment in Alzheimer's clinical trials.
Methods for More Accurate Microbiome Studies Could Impact Future Therapeutic Use – 7/26/16
A group from the University of Minnesota found that quantitative and qualitative errors in NGS library prep could be eliminated by changing four parameters in a common workflow.
Tuberculosis Detection With Cepheid Test Improved By Longhorn's Sample Transport Medium – 7/20/16
Longhorn Vaccines and Diagnostics' one-step reagent for sample collection and transport enhanced M. tuberculosis detection on the Xpert MTB/RIF assay.
Proove Biosciences Building Opioid PGx Test Evidence; Experts Question Available Data – 7/18/16
The firm has yet to publish peer-reviewed clinical evaluations, and genetics experts have raised doubts about its choice of targets to predict addiction.
Quidel's Solana Group A Strep Test Fares Well in Prospective Evaluation – 7/12/16
The rapid molecular test showed 98 percent sensitivity and 97 percent specificity on more than 1,000 throat swabs prospectively collected at four US sites.
AI Biosciences Adapts Low-Cost 3D Printer Into Sample Prep, Thermal Cycling Device – 7/11/16
The automated device was able to detect pathogens from clinical samples and can be built from a 3D printer retailing at $750 or less.
Genetic Signatures Launches Analyte-Specific Reagents in US; Eyes FDA Approval for MDx Panels – 7/8/16
The Australian firm is planning to seek US Food and Drug Administration approval for one of its PCR-based multiplex panels in the future.
Seegene Beta Testing Low-Cost Oligo Service Using Universal Fluorescence System – 7/6/16
The service — which Seegene plans to launch next year — boasts the specificity of fluorescently tagged probes at the cost of intercalating dyes.
Low-Cost HIV Resistance Testing From Aldatu Biosciences Advancing as Company Expands – 7/5/16
The firm is hiring new scientific and managerial staff as it targets distinct markets in Africa for its nucleic acid amplification-based resistance test.
BioFire Diagnostics' Meningitis, Encephalitis Panel Evaluated Favorably in Multi-Center Study – 6/28/16
The study involved 11 sites and 1,560 prospectively collected patient samples and demonstrated high overall positive and negative percent agreement with comparator assays.
Great Basin Launches Enhanced MDx Platform; Assays Favorably Evaluated at ASM – 6/23/16
Two of the firm's assays were evaluated in posters presented at a recent conference, demonstrating good performance relative to commonly used non-molecular methods.
Emergence of Superbug a Concern as Walter Reed Team Finds Colistin-Resistant Plasmid – 6/23/16
The team used screening and sequencing to discover a patient sample of E. coli harbored resistance genes on a transmissible plasmid, raising concerns about a potential "superbug."
Hologic's Zika Tests Further Firm's Reach in Women's Health, Blood Screening Markets – 6/21/16
The firm's Aptima Zika test for patients will be marketed to Ob/GYN physicians and labs with Panther systems, while the blood screen test will be used by the Red Cross.
Roche Blood Screening Test Helps CDC Show Zika Infections Increasing in Puerto Rico – 6/17/16
Roche's PCR-based Cobas test is also being deployed at one blood center in the US and is proving to be highly accurate, the agency said.
HIV Tests From Alere, Cepheid Get WHO Prequalification, Unlocking New Markets – 6/16/16
Prequalification now enables procurement in numerous countries within sub-Saharan Africa that have regulations requiring this type of oversight.
SpeeDx Opens European Offices to Launch HSV, Antibiotic Resistant Mycoplasma Genitalium Tests – 6/14/16
The antibiotic-resistant Mycoplasma genitalium test would be the first on the market for a pathogen with increasing evidence for adverse outcomes.
Alere Point-of-Care HIV Viral Load Test Shows Promise, Shortcomings in Mozambique Study – 6/14/16
The prototype showed biases at low virus concentrations and the researchers raised concerns over use of whole blood versus plasma HIV RNA as a biomarker.
Rutgers-NJMS Team Describes Multiplexed 'SuperSelective' PCR Primers for Rare Mutation Detection – 6/8/16
Rutgers researchers have published the first detailed description of the primers, describing how they could be used for quantitative multiplex cancer-related assays.
Barrett's Esophagus MDx Test From Case Western Team Gets NCI Funding – 6/6/16
Researchers will develop PCR and next-generation sequencing assays for aberrantly methylated vimentin, with the goal of commercializing a screening test.
Stanford Group Publishes Field Evaluation of Zika, Chikungunya, Dengue Triplex Assay – 6/2/16
The researchers are collaborating with agencies in Nicaragua and Ecuador and are seeking commercial partners to obtain FDA Emergency Use Authorization.
Spartan Bioscience Unveils 'World's Smallest' PCR-Based Diagnostic Device – 5/31/16
The Canadian firm will be announcing a menu for the Spartan Cube at August's American Association of Clinical Chemistry conference and will seek CLIA waiver.
Drug-Resistant Tuberculosis Test From China's Zeesan Biotech Performs Well in Clinical Validation – 5/26/16
The test, which uses melt curve analysis and runs on a fully integrated platform from Zeesan, may have a head start on MDR and XDR tests from other companies.
Point-of-Care Flu Test from Mesa Biotech May Head to FDA Next Year – 5/23/16
The firm recently made strategic hires with commercialization experience in anticipation of bringing its handheld point-of-care device to market.
HIV Screening With Molecular Test Reduces Incidence, Study Finds – 5/18/16
Researchers in San Diego collaborated with the American Red Cross to enable molecular testing, reducing incidence in the zip codes where screening was offered.
Cervical Cancer Screening Study Using Roche HPV Test Supports Idea of Self-Collected Samples – 5/17/2016
An evaluation of more than 5,000 women attending primary cervical cancer screening showed self-collection and physician-collected samples are comparable.
HPV Genotyping Test From GeneFirst Performs Well in Evaluation, Aims to Report All High-Risk Types – 5/11/16
The UK firm anticipates CE marking shortly and will focus on the European and Chinese markets for its multiplex PCR test for human papillomavirus genotyping.
Cepheid CRE Test Could Be Useful for Screening, According to International Study – 5/10/16
Using the Cepheid Carba-R test, researchers at four sites demonstrated high positive and negative predictive values.
C Diff Molecular Screening Strategy Reduces Incidence, Saves Money in Canadian Study - 5/5/16
Nearly 8,000 patients participated in a screening study that used a PCR-based detection assay from Becton Dickinson, uncovering a 5 percent carrier rate.
Thermal Gradient Begins Testing Commercial Prototypes of Point-of-Care Nucleic Acid Testing Platforms – 5/3/16
The firm has three small qPCR platforms in development for different sample types and applications, including research and diagnostics.
Cepheid Delays Launch of Omni Point-of-Care MDx System – 4/29/16
The firm postponed the launch to enhance Omni's capabilities, in the meantime focusing on opportunities in near-patient testing for its GeneXpert system.
LGC Doubles Genomics Division With Douglas, Biosearch Buys; Makes North America Axis of Operations – 4/28/16
The UK-based firm plans to marry its core strengths with the probes and PCR platforms, and to build its sales force in the US.
Cepheid HPV Testing Using Patient-Collected Samples Comparable to Physician-Collected Approach – 4/27/16
Evidence is mounting supporting the use of self-collected specimens for HPV and other infectious disease testing in both the developing and developed world.
Common Digital PCR Sample Prep Step Could Cause False Positive Mutation Detection – 4/22/16
A University of Michigan Health System team showed that heat fragmentation leads to increased detection of a G-to-A mutation of the KRAS gene in vendor-purchased DNA.
Q&A: Intermountain's Bert Lopansri Shares Perspective on PCR-Based Syndromic MDx Panels – 4/20/16
Lopansri, a clinical microbiology lab medical director who makes decisions about new tests to bring on, discussed the vagaries and thorny issues with syndromic panels.
Researchers Boost Sensitivity of HDA Isothermal Method, Develop TB Test Rivaling PCR – 4/19/16
A team in Spain used enhanced primer design, magnetic separation, and electrochemical detection to build a TB test as specific and sensitive as PCR.
InSilixa Developing Drug-Resistance TB Test Showcasing Potential for Hundreds of Targets – 4/18/16
The firm is using CMOS technology to develop a rapid TB test and other infectious disease panels, and is also partnering with other companies to enable tests.
MicroGem Sets Sights on Sample Prep, Forensics Markets After Picking up ZyGem Assets – 4/14/16
New firm MicroGem picked up the assets of bankrupt ZyGem and its affiliate MicroLab, seeing promise in the firm's extremophile enzyme collection.
Stat-Diagnostica Readies Combined Immunoassay, PCR Platform for 2017 Launch – 4/12/16
The Spanish firm obtained €25M in a Series C financing round this week and anticipates launching the new platform, called DiagCore, next year.
Abbott Developing Next-Generation MDx System for 2017 Launch Outside US – 4/7/16
Abbott Molecular has been building a PCR-based system from the ground up and plans to sell it in parallel with the m2000, eventually replacing that system.
NGS-Based Pipeline Used to Develop Improved Parasitic Worm MDx – 4/6/16
Researchers at Smith College used NGS and a Galaxy-based software called RepeatExplorer to design improved assays for soil-transmitted helminths.
US Fraunhofer Center Develops Method for Mass Manufacture of Low-Cost Continuous Flow PCR Devices – 3/30/16
The non-profit group is interested in improving manufacturing efficiencies to make point-of-care diagnostics more accessible.
Researchers Describe 'Digital PLA' Method to Quantify mRNA, Protein in Single Cells – 3/28/16
The new technique uses a proximity ligation assay and digital PCR and has femtomolar sensitivity, according to a recent study.
Ubiquitome Turns to Crowdfunding to Develop, Validate Zika MDx for Potential EUA – 3/21/16
The firm is offering testing through a centralized lab as an incentive to donors but is also developing the test for use with its portable Freedom4 PCR system.
Rheonix Completes Initial Testing of Self-Confirming HIV Diagnostic on Automated System – 3/16/16
The firm's dual assay for host antigen to HIV as well as viral RNA was described in a proof-of-principle study earlier this year.
French Firm Stilla Technologies Unveils Three-Color 'Crystal Digital' PCR Platform – 3/16/16
Based outside Paris, Stilla has developed a novel digital PCR system in stealth mode and has begun demonstrating it at conferences to attract partners and users.
Researchers Demonstrate New PCR-Based Method More Sensitive Than ELISA in Detecting Antibodies – 3/9/16
Researchers at Stanford have developed a technique that relies on proximity-based amplification and are launching a company to commercialize the method.
Rapid, Inexpensive 'Lab-on-a-Drone' PCR Enabled With Convective Flow Thermal Cycling – 3/8/16
Researchers have demonstrated the method can be used to run rapid diagnostic assays, with the quadcopter drone's blades adapted to centrifuge spin columns.
Siemens to Release RUO Zika Test While Seeking Emergency Use Authorization – 3/2/16
The firm also plans to launch its Versant MDx System sample prep module in the US next month for use with the test.
Researchers Describe Rapid, Multiplexed High-Res Melt Assay for Species Differentiation – 2/25/16
The assay uses a dye from BioFire Defense, can differentiate species relevant to forensic applications, and could also be developed for other uses.
Houston Hospitals Begin In-House Zika Testing Using Lab-Developed Assay – 2/25/16
The two Houston hospitals say the LDT, which relies on reagents from Altona Diagnostics, is the first hospital-based rapid assay in the US.
Hologic Hepatitis C Viral Load Test Fares Well in German Validation – 2/24/16
A German clinical lab found that the test, run on Hologic's Panther system, was slightly more sensitive than a Roche assay on the High Pure System.
AI Biosciences Thermos Thermal Cycler Adapted for Multiplexing, RT-PCR – 2/17/16
The firm has improved design of the system for low-resource settings and validated it on clinical chlamydia samples and extracted HIV, Ebola, and dengue samples.
Mayo Clinic Lab Discovers New Lyme Disease-Causing Bacterium Using Routine Melt Curve Analysis – 2/11/16
The reference lab noted unusual melt temperatures in samples processed for Lyme disease, and collaborated with others to find the spirochete in Upper Midwest ticks.
With a New Identity, Liquid Biopsy Firm Celsee Looks to Move CTC Isolation Tech to Clinic – 2/10/16
The firm recently changed names and added vice presidents of quality and commercial operations with the goal of growing its circulating tumor cell sample prep business.
GenArraytion Launches Test for Mosquito-Borne Pathogens Amid New CDC Zika Testing Guidelines – 2/5/16
The new test distinguishes Zika from other viruses in mosquito vectors and launches during an ongoing outbreak that has prompted new CDC guidelines.
Abbott's Alere Buy Signals Strength of POC Market – 2/4/16
PremiumAbbott's move came as somewhat of a surprise, but analysts have noted the potential for a trend in point-of-care diagnostics acquisitions.
Interpace Diagnostics Shows Pancreatic Cyst Test Improves Patient Management – 2/3/16
The firm performed a long-term, prospective study and noted that the test improved outcomes for patients and helped doctors monitor patients with benign disease.
CDC Recommends Zika Testing for Some Pregnant Women; Labs Developing New MDx Tests – 1/27/16
Federal and State labs now provide testing using the CDC's PCR-based assay for acute virema, and some commercial firms are also developing molecular tests.
Catalyst-Based Thermodynamics Method Could Enable Improvements in DNA Oligo Design – 1/26/16
The method dramatically reduces time to equilibrium and could enable better determination of DNA hybridization thermodynamics.
IS-diagnostics Publishes Validation of PCR-Based Clinical Metagenomic MDx - 1/22/16
In a recent study of clinical samples, the firm's IS-pro method detected more bacterial species than routine culture, including in culture-negative material.
Italian Researchers Validate CastPCR as Companion to TKI Treatment for BRAF Mutated Melanoma – 1/20/16
A study of 54 patient samples showed castPCR was a sensitive and specific method to detect V600E and V600K mutations in melanomas.
Startup DNAsimple Aims to Provide Genetic Researchers With Donor Samples – 1/19/16
The firm has created a database of donors and can ship samples to researchers for about half the cost of generating a sample set in house.
Qiagen Aims to Broadly Occupy Liquid Biopsy Space with Technologies, Platforms – 1/14/16
Company executives provided GenomeWeb with an update on the firm's liquid biopsy-related offerings, from sample prep to sequencing and informatics.
Illumina, Bio-Rad Form Alliance for Single-Cell Sequencing System – 1/13/16
The firms will develop a workflow for single cell genomic analysis using a modified version of Bio-Rad's droplet generator instrument.
Sandia Researchers Developing Multiplex Assay Differentiating Viral Febrile Illnesses, Malaria – 1/13/16
The researchers are using an NIH grant to develop a device to discriminate various fever-causing viruses endemic to West Africa and Plasmodium falciparum.
BioMérieux Aims to Expand Food Testing Footprint With GeneUp Launch – 1/5/16
The platform meets the needs of customers preferring molecular testing over immunoassays, and enters a dynamic and rapidly expanding food testing market.
Study Describes 'World's Smallest' qPCR Platform – 12/23/15
The fully autonomous device has a footprint slightly larger than a business card, and its developers believe it could be made even smaller.
With Global IP Secured, ImmunID Outlines Plans for PCR-Based Cancer Companion Test Market -12/18/15
The firm anticipates CLIA certification for its European lab soon, enabling it to profile US patients' T cell repertoires using a multiplexed PCR-based assay.
German Group Develops On-Chip RPA Arrays for Isothermal Detection of Viruses, Bacteria – 12/16/15
The adaptable technology uses flow-through microfluidic chips and can detect three pathogens simultaneously with virtually unlimited potential array sizes.
Meridian Developing Malaria Assay; Provides Update on Business – 12/9/15
The company's direct-from-blood test detects low levels of plasmodium parasitemia and runs on Meridian's Illumigene isothermal molecular diagnostic platform.
RainDance, BSRI Partner to Quantify Latent HIV at Newly Created AmfAR Research Institute – 12/7/15
The UCSF-based Blood Systems Research Institute will conduct research using RainDance's digital PCR platforms as part of a new $20 million amfAR Institute for HIV Cure Research.
Exosome Diagnostics Launches Clinical Commercialization Program to Move Biomarkers to Dx Products – 12/3/15
The firm is also expanding its diagnostics sales force and adding development and regulatory staff ahead of near-term product launches.
Researchers Evaluate Enigma's Multiplex POC Flu/RSV Assay as Firm Touts Syndromic Capabilities – 12/2/15
The Enigma MiniLab runs single-tube multiplex panels at the point of care, with a lower price point than other commercially available syndromic panel platforms.
Swedish Study Evaluates BD Enteric Parasite Panel – 11/25/15
In a set of previously evaluated clinical samples, the panel showed good specificity for all targets, with sensitivity for one target equivalent to microscopy.
QuanDx to Distribute Zeesan's High-Risk HPV Genotyping Assay in Europe – 11/25/15
QuanDx will market the HPV test in Europe, where it also markets a CE-marked multiplex test for 30 leukemia fusion genes, called Q-fusion.
Economic Model Says Cervical Cancer Co-Testing with mRNA-Based MDx Could Save Lives and Money – 11/18/15
The Hologic-funded model predicted co-testing would lead to a lifetime savings of $39 per woman, with high cancer detection sensitivity and fewer false positive results.
Canada's GenePOC Expanding to Enter Lab, Point-of-Care MDx Market Next Year – 11/18/15
The Quebec City, Canada-based firm will launch its point-of-care molecular platform with GBS and C. diff tests next year as CE-IVD products.
BioFire Defense Ebola Test Fares Well in Sierra Leone, UK Evaluation – 11/11/15
A study of samples from Sierra Leone and the UK of heat-inactivated whole blood showed high sensitivity and specificity using the FilmArray BioThreat-E test.
Karolinska Institute, Thermo Fisher Collaboration Yields Improved Prostate Cancer Screen – 11/10/15
In a large, prospective study published in Lancet Oncology, the screening assay was projected to reduce the number of prostate biopsies by 32 percent.
Agena Bioscience Partners With Diatech Pharmacogenetics to Commercialize Oncology CE-IVD Assays – 11/4/15
The firms will collaborate to develop and commercialize multiplex panel assays detecting sets of about 200 mutations associated with different cancers.
HLI-led Study Compares NGS Library Prep Methods, Recommends PCR-Free for Microbiome Analysis – 11/3/15
A study published in PNAS by Human Longevity shows that library preparation methodology can impact the results of human microbiome studies.
Canadian Startup Qvella Developing MDx System for Sepsis – 10/30/15
The firm's core technology involves electrical charge-based isolation of bacterial and fungal cells from whole blood, with in-cartridge lysis and RT-PCR.
Brown Group Develops One-Step Ligation on RNA Amplification to Detect Drug-Resistant HIV – 10/28/15
The method simplifies previous techniques, and preliminary testing using a microfluidic device indicates it could ultimately be used in low-resource settings.
European Trial of Beckman Coulter DxN Veris Shows Workflow Improvements for MDx Testing – 10/26/15
Following a beta evaluation of the system, a virology lab in Sheffield, UK, ran a workflow assessment and found improvements with the system.
Clinical Evaluation of Molecular CRE Test Spurs Concerns About Potential Use in Screening – 10/23/15
A clinical lab evaluation of carbapenem-resistant Enterobacteriaceae screening using a molecular test showed a high level of false positive results.
Study Using EKF Enrichment Tech Highlights Liquid Biopsy Advantages Over Tissue Samples – 10/22/15
Researchers from a SU2C-sponsored study compared tissue biopsy and liquid biopsy for detecting the T790M mutation of the EGFR gene in a cohort of NSCLC patients.
Cepheid Cites Sales Force Expansion Delays in Lackluster Q3 Earnings – 10/21/15
The firm claimed delays in a planned sales force expansion were partly to blame for lower-than-expected revenues; it also announced the FDA clearance of an assay forTrichomonas vaginalis.
Natera Describes Massively Multiplexed PCR Technology, Liquid Biopsy Pipeline at ASHG – 10/14/15
The firm is morphing its massively multiplexed PCR-based method for non-invasive prenatal testing to develop tests for ovarian, breast, and lung cancers.
ASHG Studies Highlight Diverse Applications for Bio-Rad's ddPCR as Tech Moves Toward Clinical Use – 10/13/15
Posters described Droplet Digital PCR for oncology, somatic mosaicism detection, and gene editing methods development.
Researchers Develop New Method for PCR Testing of Soil, Water, Aerosol – 10/12/15
The method is faster and less expensive than traditional culture methods and was shown to be highly sensitive.
SpeeDx Launching Line of Multiplex STI, Microbial Resistance Assays – 10/7/15
The Australian firm provided an update on its in vitro diagnostics business, noting that it has also rebranded its core technologies and continues to license them.
Austrian Group's Inflammation Study Yields Insights Into Reference Gene Quandary – 10/7/15
A recent study determined a particular geneset was the best method to normalize RT-qPCR data from a specific model system, with caveats.
Lack of Guidelines for Group A Strep MDx Tests May Influence Adoption; IDSA Update Forthcoming – 10/2/15
A number of firms now have FDA-approved Group A Strep assays, but end users may be hesitant to adopt them until Infectious Disease Society of America guidelines are updated.
Capturing Droplets in Beads, Epic-PCR Enables Massively Parallel Single-Cell Sequencing – 9/30/15
A method developed at MIT creates polyacrylamide beads around droplets containing single cells to sequester bacterial genomes and allow for harsh lysis conditions; it then uses concatenated PCR and sequencing to address links between phylogeny and function.
Physician-Investigators Win $5.8M in NIH Funds to Detect Bacterial Infection in Febrile Infants – 9/30/15
The team has been monitoring changes in host gene expression patterns due to different types of infections, and hopes to develop a diagnostic test.
Streck to Debut Modular, Rapid qPCR Thermal Cycler at ASHG – 9/28/15
The company will showcase the next generation of its Philisa platform, a real-time PCR system which can run four multiplexed qPCR protocols in about 20 minutes.
Chinese Group Develops Multicolor Melt Curve Test for Non-Deletional Alpha-Thalassemia Mutations – 9/23/15
The test uses multicolor high-resolution melt analysis to detect mutations that lead to a potentially fatal blood disorder particularly common in Asian populations.
Study Finds Customized TaqMan Array Card IDs More Respiratory Pathogens Than Conventional Methods – 9/23/15
Researchers in Belgium and the UK showed that their custom viral panel on Thermo Fisher's TaqMan qPCR array card is effective in samples from immunocompromised patients.
Stanford-led Group Validates Multiplex Tropical Pathogen PCR for Plasmodium Species Detection – 9/22/15
The assay was demonstrated to be as effective as microscopy and a rapid immunoassay at detecting Plasmodium falciparum in a sample of febrile patients in Nigeria.
Droplet Size Used as qPCR Readout in Prototype Device to Detect Heart Infections - 9/11/2015
A proof-of-principle study has shown a new qPCR device can detect bacterial DNA in under four minutes using droplet size as a readout of amplification.
Canon BioMedical Launches First Commercial PCR Products - 9/9/2015
The firm has launched genotyping assays that rely on PCR followed by high-resolution melt analysis, as well as master mix companion chemistry.
UCSD Researchers Win Grant to Develop Extracellular RNA Biomarker Panel for Glioma - 9/9/2015
The funding coincides with publication of reports from the Extracellular RNA Consortium outlining growth and challenges in exosomal RNA-based diagnostics.
IntegenX Launches Next-Generation Rapid Forensic DNA Platform - 9/3/2015
The new platform is smaller and less expensive than the company's first-generation forensic DNA platform, processing a single DNA sample in around 70 minutes.
Abbott Provides Update on Multi-Drug Resistant TB Test for Centralized Labs - 9/2/2015
The test runs on the firm's m2000 PCR platform and is the first on the market to assess resistance to both rifampin and isoniazid.
Study Shows One Tenth of miRNAs From Stored Plasma Samples Meet Reproducibility Standards - 9/1/2015
Six out of 61 miRNAs in a prospective cardiovascular disease study could be reliably measured from plasma samples after more than a dozen years in liquid nitrogen.
Silicon Valley Startup Cell Data Sciences Aims to Improve Nucleic Acid Yield from FFPE - 8/26/2015
Cell Data Sciences plans to commercialize a technology that uses a chemical catalyst to help remove formaldehyde-associated adducts and crosslinks.
Hopkins Team Shows Methylation-Specific ddPCR May Help Predict Head and Neck Cancer Recurrence - 8/26/2015
Spokespersons from Bio-Rad noted that there appears to be an increasing number of researchers using ddPCR for methylation analyses.
With New Law Passed, NYC Will Consider Testing Options for Legionnaire's Disease - 8/19/2015
Though PCR testing would provide rapid results, its sensitivity could also present problems, potentially detecting both live and dead bacteria.
Lucigen Continues Development of POC Platform, C Diff TestConfigure - 8/19/2015
The firm presented results of a pre-clinical evaluation of the test and platform yesterday at the Next Generation Dx Summit in Washington, DC.
International Study Validates Veredus 'Lab-on-Chip' Multi-Drug Resistant TB Test - 8/12/2015
The VereMTB assay is a disposable microfluidic device consisting of PCR and microarray modules, and could be cheaper and more versatile than current molecular tests.
German Team Develops Bacterial Pathogen Test on Prototype Qiagen Compact Analyzer - 8/12/2015
In a proof-of-principle study, the group showed the centrifugal microfluidic test could be highly sensitive and fast, underscoring its potential in point-of-care diagnostics.
Beckman Coulter Builds Test Menu on Veris MDx Platform; US Launch Still Few Years Out - 8/5/2015
The DxN Veris was recently launched as a CE-marked product with a menu of viral load tests, and will launch in a few years in the US with STD and HAI assays.
BioMérieux Aims to Simplify, Quicken PCR Setup With New Automated Sample Prep Instrument - 08/5/2015
The instrument is compatible with the firm's easyMag sample extraction platform, as well as four different thermal cyclers and two other types of consumables.
Johns Hopkins Researchers Develop Handheld Chlamydia Test Using Microfluidics, Smartphone - 7/29/2015
The lightweight, mobile device was highlighted in an oral presentation at AACC today.
Cepheid Introduces True Point-of-Care Molecular Platform at AACC Analyst Event - 7/27/2015
The Xpert Omni platform will launch in 2016 running Cepheid test cartridges on a compact battery-operated device that is anticipated to cost less than $3,000.
Canadian Clinical Lab Crunches Years of MDx Data to Show Frequency of PCR Artifacts - 7/22/2015
A lab in Quebec analyzed more than 30,000 samples run routinely with two sets of non-overlapping primers, revealing one in every 227 results had PCR failures.
SNP Test Aims to ID Patients Who May Spontaneously Clear HCV - 7/22/2015
The new assay uses high-resolution melt curve analysis to detect variations in genes that lead some people to spontaneously clear hepatitis C viral infections.
NY DOH Develops Multiplex Real-Time PCR to Combat Staph Food Poisoning, Bioterrorism -7/15/2015
The assay was developed in the Wadsworth Center Biodefense Laboratory and includes a novel sample prep enabling detection from stool.
Elucigene Diagnostics to Launch CE-Marked Y-Chromosome Microdeletion MDx for Male InfertilityConfigure - 7/15/2015
The UK-based company also makes assays for recurrent pregnancy loss, and plans to enter the US reproductive health market.
High School Student's Immune Cell Epigenetics Experiment to be First PCR Aboard ISS - 7/13/2015
Co-sponsored by Boeing and miniPCR, the winning high school student's project will be carried out by astronauts aboard ISS and is believed to be the first ever PCR in space.
AI Biosciences Develops Cheap, Rapid DIY Thermal Cycler for Low-Resource Settings - 7/8/2015
The thermal cycler costs less than $130 to build using off-the-shelf supplies and boasts speeds of 17 seconds per cycle.
Economic Model Describes Cost Effectiveness of FilmArray Respiratory Panel for Kids - 7/8/2015
The special conditions of MDx use in the pediatric market may also present advantages in patient satisfaction metrics, a BioFire representative said.
Finland's Orion Diagnostica Launches C. diff Kit for GenRead Isothermal MDx System in Europe - 6/29/2015
The assay is the first on the firm's isothermal nucleic acid amplification-based platform.
European Researchers Enable Single-Dye Multiplex qPCR via Melt-Curve Analysis in Each Thermal Cycle - 6/24/2015
A proof-of-principle study demonstrated the method's effectiveness by assaying samples spiked with avian influenza virus using a handheld device.
Qiagen Launches STR Typing Kits for Forensics Market, Building on Sample Prep Foundation - 6/22/2015
The firm has timed the launch with FBI-mandated CODIS expansion, a period when labs will be evaluating and adopting new products.
Study Shows Thermo Fisher's PikoReal Thermal Cycler Ideal for Mobile Biothreat Detection - 6/17/2015
Acquisitions in the past few years have enriched Thermo Fisher's portfolio of PCR platforms, but the firm says the PikoReal is not being developed for IVD use.
BJS Biotechnologies Eyes Near-Patient Clinical Market for Ultra-Fast Thermal Cycler - 6/15/2015
The UK-based firm is also part of a consortium developing a two-hour sepsis test.
Recent CDC Evaluation of Commercial MERS MDx Could be Boon in Light of New Outbreak - 6/9/2015
The agency tested assays from Altona Diagnostics, Fast-track Diagnostics, and PrimerDesign against its own EUA-approved rRT-PCR assay.
Study Shows Impact of BD Max Enteric Bacterial Panel on Lab WorkflowConfigure - 6/8/2015
The impact study included time-motion analysis of all steps for the EBP compared to stool culture.
Mayo Researchers Test FilmArray Blood Culture ID for Prosthetic Joint Infections - 6/8/2015
The BCID assay was used off-label on biofilms dislodged from infected prostheses using sonication.
Q&A: Peter Vallone of NIST Talks Trends in Rapid PCR for Forensics - 6/3/2015
Vallone recently authored a review of the field, noting that fully integrated rapid systems have special advantages.
Pooling Samples Leads to 30 Percent Cost Savings for Xpert TB Testing - 6/3/2015
A study of more than 700 samples showed pooling detected 96 percent of the tuberculosis cases found via testing each patient sample individually, with 99 percent overall agreement between the methods.
EliTech Targeting Transplant Pathogen Monitoring with Sample-to-Answer qPCR Platform - 5/27/2015
The firm is pursuing CE-IVD clearance of the new platform populated with a menu of its MGB assays.
New Multiplex qPCR Assay May Enable Better Chagas Disease Monitoring - 5/27/2015
The TaqMan PCR classifies six types of Trypanosoma cruzi and was validated on a large international set of samples.
As Roche Grows its Rapid MDx Menu for Liat, Clinical Evaluations Hit the Presses - 5/20/2015
The firm received CLIA waiver of a strep A assay on its Liat platform yesterday, and a favorable evaluation of its influenza A/B assay was published last week.
Janssen Diagnostics, Biocartis Collaboration Yields Prototype HCV, Flu/RSV, Flu Surveillance Tests - 5/13/2015
Three new assays were presented in posters at April's Clinical Virology Symposium.
Researcher Reports Progress in Metagenomic Sequencing for Pathogen ID Using MiSeq, MinIon - 5/7/2015
A recent presentation at the Clinical Virology Symposium highlighted the potential of unbiased sequencing for diagnosing infectious disease.
Q&A: BioMérieux's Christine Ginocchio Chats About Her Clinical Lab Career Arc, Syndromic PCR Panels - 4/30/2015
GenomeWeb caught up with Ginocchio at the Clinical Virology Symposium this week in Daytona Beach, Fla.
At Virology Meeting, Quidel Gives Update on Solana MDx Platform; Researchers Share Data on AmpliVue - 4/29/2015
The presentations were part of a Quidel-sponsored workshop and poster sessions at the Clinical Virology Symposium in Daytona Beach, Fla.
Cepheid Sees 'Significant Opportunity' in Menu Expansion, CLIA Market - 4/26/2015
The firm is pursuing regulatory clearance for multiple tests and is targeting growth in an attractive CLIA market, a move that will require new hires.
UPDATE: Head-to-head Study of qPCR Assays for MRSA Surveillance Shows LightCycler Most Cost-effective - 4/22/2015
The study evaluated three commonly used tests, and found that slight differences in specificity could lead to unnecessary patient isolation.
Repurposed Microfluidic CTC Purification Tech Enables Blood-based Antibiotic Resistance Test - 4/22/2015
The method uses a type of flow fractionation, ribosomal RNA-based species identification, and mRNA signatures of antibiotic exposure.
Inexpensive Assay Differentiates Two Diffuse Large B-Cell Lymphoma Subtypes - 4/17/2015
The method could potentially be useful as a companion diagnostic for targeted drug therapies.
Toshiba Developing Food Poisoning Panel Using Isothermal Amplification Technology - 4/15/2015
The assay uses the firm's Genelyzer DNA chip card and tests for 14 food-borne pathogens.
Seattle Startup AttoDx Wins NIH Funds for Ultrasensitive TB MDx - 4/15/2015
The test detects a signature molecular marker upregulated by viable bacteria, and will be useful for pediatric, extrapulmonary, and AIDS-related TB.
'Printing' 2D Droplet Arrays Enables Inexpensive Automated Single-Cell RT-qPCR - 4/8/2015
The simple, semi-open format uses a microfluidics robot to generate an array of picoliter droplets on a reusable chip.
Sandia Researchers Invent Wheel-based Thermal Cycler - 04/06/2015
The new device rotates heating blocks to contact a stationary sample and is meant to be integrated with a plug-and-play digital microfluidics hub.
Clinical End Users Embrace PCR MDx Panels as Debate Continues on Size, Cost, Utility - 04/03/2015
Building on a recent point-counterpoint in the Journal of Clinical Microbiology, lab directors discuss pros and cons of large MDx panels for infectious disease testing.
Outbreak of EV-D68 Detected by Cross-reactivity in GenMark Respiratory Viral Panel - 03/31/2015
The firm is now consulting with experts to evaluate detection of enteroviruses and rhinoviruses in respiratory specimens for its next-generation ePlex system.
New Method 'Dumbbell PCR' Enables Easy Quantification of microRNA Isoforms - 03/20/2015
The method can distinguish terminal isoforms of small RNAs, and could be useful in biomarker analyses.
Study IDs TB Strains in Swaziland with Drug Resistance Mutations Not Detected by Cepheid Xpert Test - 3/19/2015
Cepheid is now considering adapting TB tests in development to cover the mutations, an executive told GenomeWeb.
BD Max Enteric Bacterial Panel Superior to Conventional Methods in Large Evaluation - 03/17/2015
The firm's approach to panels is more focused than the competition, according to a BD executive.
BioFire Respiratory Panel Less Sensitive for Pertussis than Standard PCR; Has Specificity Edge - 03/13/2015
BioFire expected the result, and said it stands by its decision to choose a more specific target for Bordetella pertussis for its FilmArray panel.
Ubiquity Genomics Commercializing Catch-seq Target Capture Technology - 03/11/2015
Premium
Enrichment prior to amplification better enables studies of non-coding regions and epigenetic analyses, according to Ubiquity's founder.
Increasing Prevalence of MDx Ups C. diff Burden Estimates in New CDC StudyConfigure - 03/05/2015
More nucleic acid amplification test usage is ultimately good for patients, hospitals, and the MDx industry, according to a maker of the most widely used assay.
Alere Rapid POC MDx Platform Close to Commercialization in Non-US Markets - 03/03/2015
Tests in development for the Alere q include HIV, tuberculosis, and Ebola assays, and it will initially be targeted to low-resource settings in the developing world.
Germany's GNA Biosolutions Developing Ultrafast 'Laser PCR' Ebola Test, Pathogen Testing Platform - 02/26/2015
The firm has also created a qPCR-based Staphylococcus aureus resistance gene assay with a run time of three minutes.
Agena Bioscience Launches Smaller Format MassArray as Part of New Clinical Direction - 02/24/2015
The firm is also positioning MassArray as a complementary technology to NGS, and hopes to tap into the LDT and liquid biopsy arenas.
Molecular Testing Shows Bacterial Cause of Sore Throat as Common as Strep - 02/24/2015
Infection with Fusobacterium necrophorum resembles strep throat, and may be as prevalent in young adult populations.
Abbott Pathogen Detection Platform Compares Well to PCR-based Gold Standards for Influenza A/B - 2/20/2015
The RT-PCR/ESI-MS system showed similar sensitivity and specificity to tests from Cepheid and Hologic.
Douglas Scientific Doubles Throughput with Launch of IntelliQube PCR Platform - 02/17/2015
The automated platform runs a higher-throughput version of the firm's Array Tape.
Study Describes pH-based Method Potentially Useful for POC MDx - 02/13/2015
Developed by New England Biolabs, the method uses pH-sensitive colorimetric dyes and is being utilized by the company to create assays for neglected tropical diseases.
Alere Officials Discuss Advantages of POC Platform as Firm Shifts Focus to MDx - 02/11/2015
The firm is focused on moving more of its business into the molecular diagnostics market, and it believes the recent CLIA waiver for its Alere i platform provides it with a market opportunity not available to competitors.
Study Claims PCR from Primers Annealed in Parallel Orientation - 02/06/2015
If validated, the technique could help explain nonspecific errors observed in PCR and other molecular techniques.
Study Describes Blood Biomarkers of Huntington's Disease Progression - 02/05/2015
The panel may prove useful in clinical trials of drugs interfering with mutant gene expression, the researchers said.
Study Shows Preemies' Oral Feeding Readiness Predicted By Salivary BiomarkersConfigure - 02/02/2015
Researchers are now seeking collaborators to help develop and commercialize the new assay.
Tetracore Wins NIH Funds for Chikungunya/Dengue MDx on Its POC ThermocyclerConfigure - 01/30/2015
With eight independently programmable amplification wells, the firm's portable PCR platform is now in small-scale production.
Combined NGS, ddPCR Method Reveals Integer Copy Numbers for Multiallelic CNVs - 01/29/2015
The research may prove relevant to understanding human diversity as well as the genetic underpinning of certain CNV-related disorders.
Use of MDx Tests for Animal Health on the Rise, but Cost Concerns Present Significant Hurdle - 01/26/2015
Industry and federal sources suggested that molecular methods remain on the rise in veterinary diagnostics labs. Part two of a two-part series.
As ddPCR Studies Mushroom, Major Players Bio-Rad, RainDance Eye Emerging Applications - 01/23/2015
An increasing number of publications using droplet-based digital PCR platforms suggests acceptance and uptake of the technology.
New Method Pairs Artificial Nucleotide, Mutant Polymerase to Detect DNA Adducts - 01/21/2015
The technique has the promise of enabling basic cancer research, and could also be used for in vitro screening of chemotherapeutic drug response.
Comparison Shows Life Tech CastPCR Provides Equivalent Results to Therascreen for KRAS Detection - 01/19/2015
The customizable PCR plates may also be less expensive than the FDA-approved Therascreen kits.
Tight Margins, Federal Regulations Constrain Infectious Disease MDx for Animal Health - 01/15/2015
With overlapping technologies, some firms pursue parallel human and animal health diagnostics development, but cost constraints and regulatory dynamics differ. Part one of a two-part series.
With CLIA Waiver and Widespread Flu, Alere Ramps Up Molecular Test Production - 01/12/2015
The waiver opens up a significant new opportunity for Alere within the physician office market, according to a company executive.
Study Suggests Feasibility of Immune-Response Biomarker Panels to Detect Latent Tuberculosis - 01/09/2015
An RT-qPCR-based assay of antigen-stimulated blood is a possible next-gen approach for latent TB detection, a Cepheid executive noted in an accompanying commentary.
Infectious Disease MDx 2014: qPCR for Ebola; Disease Panels; Isothermal Amplification - 01/05/2015
Trends included expanding test menus and a possible tipping point for point-of-care.
SpeeDx Preps to Launch Meningitis MDx Test in 2015, Provides Update on Partners' Plans - 12/24/2014
After receiving ISO certification and publishing studies on its technology in 2014, the Australian MDx firm is targeting a launch of its meningitis test in 2015.
SickKids Researchers Publish Pre-PCR Method for SNPs in GC-rich Regions - 12/22/2014
The new method may help the genomics community learn more about these difficult-to-access regions of allelic variance.
U of Maryland Scientist Wins NIH Grant to Detect HIV Using RT-binding Aptamers - 12/19/2014
With the precision of PCR, the method could ultimately be used to build faster, simpler diagnostics.
Uppsala U Team Adapts Padlock Probe Method to Detect Antibiotic-Resistant UTIs - 12/11/2014
The researchers are also developing the method in tandem with a more extensive pathogen profiling diagnostic platform from Swedish startup Q-linea.
BioInnovation Solutions, Enzymatics Validate Isothermal Ebola MDx on West African Outbreak Samples - 12/08/2014
BioInnovation Solutions, formerly Pathogenica, and Enzymatics are developing a rapid Ebola diagnostic and have validated it on patient samples in Nigeria.
Study Shows FFPE Pre-PCR Processing Problems Plague Pathology Labs - 12/05/2014
A study comparing DNA extracted from standardized blocks of FFPE showed variability among experienced molecular pathology labs.
Head-to-head of Commercial Total RNA Extraction Kits Reveals 'Practical Differences' - 12/04/2014
A new study compares kits from Qiagen, Ambion, and Promega, assessing quality and quantity of RNA extracted from small tissue samples.
Kenyan Researchers Combine Nested PCR, High-Resolution Melt to Detect, Type Malaria - 12/02/2014
The new method detects very low levels of parasitemia which could be useful for future malaria erradication efforts.
Q&A: Clinical Microbiology Lab Director Nathan Ledeboer on MDx Trends - 11/26/2014
Point-of-care testing, automation, and panelization of nucleic acid amplification testing are the future of the clinical lab ― and will likely change how labs and clinicians relate.
New Blood-based Alzheimer's Biomarker Panel Uses Exosomal miRNA - 11/21/2014
An exosomal-miRNA signature of Alzheimer's disease may one day be used to screen patients with cognitive impairment prior to referral for more involved testing.
Proof-of-concept C. diff MDx Device Uses Isothermal Amplification, SlipChip Microfluidics - 11/20/2014
New micro-device is inexpensive to manufacture and can run nucleic acid amplification at room temperature.
Rice U Team Shows Feasibility of Body Heat-activated Isothermal Amplification for Low-resource MDx - 11/18/2014
Isothermal molecular method incubated in the armpit allows researchers to detect HIV-1 DNA in proof-of-concept study.
Study Shows High Variability in Reverse Transcription Efficiency - 11/13/2014
Though reverse transcription of RNA to cDNA is an essential first step for a growing number of genomics applications, researchers have long known of problems associated with RT and its ...
New Method Helps Track Kinetics of Oral Polio Vaccine Shedding - 11/13/2014
Tracking immunity and virus shedding after oral polio vaccination usually requires culture of poliovirus from stool samples. Now, a team of researchers in the US and Bangladesh has ...
New Guidelines Encouraging NAATs for Chlamydia, Gonorrhea Screens May Increase MDx Competition - 11/06/2014
In the first update since 2007, the US Preventative Services Task Force recently provided new guidelines to clinicians for chlamydia and gonorrhea screening. These follow an update ...
Forensic Method For Snakebites May Lead to Rapid MDx - 11/06/2014
An international team of tropical medicine researchers has developed a forensic procedure that can accurately identify the culprit in approximately one in four cases of snakebite. ...
Amplyus Launches Kickstarter to Move MiniPCR into Full Production - 10/30/2014
Cambridge, Mass.-based Amplyus has launched a Kickstarter funding campaign intended to bring its miniPCR platform into full production and "open the world of DNA science to everyone, ...
Isothermal Quadruplex Priming Amplification Moves Closer to Point-of-Care MDx Applications - 10/30/2014
In an effort to design primers that might solve the conundrum of the plateau effect in PCR amplification, researchers at Ohio State University and Ilia State University in the country ...
Lucigen to Seek FDA Emergency Use Approval for Isothermal Point-of-Care Ebola Test - 10/23/2014
Using fever to screen for Ebola casts a wide net, while standard RT-PCR requires many hours and expert technicians. Now, Madison, Wisc.-based Lucigen is accelerating development ...
Sandia Method Prevents Droplet Drying in Digital Microfluidics - 10/23/2014
Manipulating miniature droplets and subjecting them to high temperatures on an open digital microfluidic device leads to evaporation that can seriously disrupt concentration-dependent ...
Firms and Federal Labs Flock to FDA Seeking Emergency Use Authorization for Ebola MDx Assays - 10/21/2014
At least five companies have indicated they will pursue or are considering pursuing Emergency Use Authorization from the US Food and Drug Administration to make nucleic acid tests for Ebola ...
In Battle of HPV Assays, Opinions Differ on Relative Importance of Sensitivity and Genotyping - 10/16/2014
A recent evaluation of FDA-approved molecular HPV screening assays from Roche, Hologic, and Qiagen has found that the three tests showed variations in which samples tested positive ...
CDC Begins Using New, Faster PCR Test for Enterovirus 68 - 10/16/2014
As a rare strain of enterovirus continues to sicken children nationwide, the US Centers for Disease Control announced this week it has developed an enterovirus 68-specific PCR test ...
New Melt Curve Machine Learning Method Enables Large Scale Genotyping of Sequence Variants - 10/09/2014
High-resolution melt curve analysis is a robust and simple way of querying the genotypes present in heterogeneous samples, since curve shapes and melting temperatures are related ...
Study Provides Blueprint For Porting Lab-Developed PCR Assays to BD Max Open System - 10/09/2014
In cases where US Food and Drug Administration-cleared assays do not exist, clinicians often use their own lab-developed PCR assays to test for conditions of interest. This process can ...
Alere's $12.9M BARDA Contract to Fund Next-gen Isothermal MDx Platform, Flu Test - 10/02/2014
Although Alere launched the Alere i molecular diagnostic platform and influenza assay only three months ago, the company announced this week that a three-year contract worth up ...
Study Validates Cepheid Xpert Flu in ER Setting as Firm Targets Rapidly Crowding Flu MDx Market - 10/02/2014
Researchers at Johns Hopkins University have performed the first validation of the Cepheid Xpert Flu assay in a population of emergency room patients with acute undifferentiated respiratory ...
Lamprogen Wins Funding to Develop 'Self-Digitizing' dPCR Platform - 09/25/2014
Seattle-based start-up Lamprogen, a spinout of the University of Washington, is using funding from two grants to further the development of a self-digitizing microfluidic chip ...
FocusDx Simplexa Dengue Test Outperforms Three Other Molecular Assays in Clinical Evaluation - 09/25/2014
Researchers in Martinique recently compared four dengue virus detection kits to a hemi-nested RT-PCR test used for routine dengue diagnosis, finding that the Simplexa Dengue assay produced ...
Northwestern Researchers Develop RT-qPCR Assay for Depression Biomarkers, Seek Industry Partners - 09/18/2014
Scientists at Northwestern University have developed a blood-based biomarker assay of clinical depression. The assay uses reverse-transcriptase quantitative PCR to detect levels of RNA ...
Baebies Enters Phase II of NIH Funding for Droplet-based Neonatal Saliva Screen for CMV - 09/18/2014
Headed by a co-founder of Advanced Liquid Logic, startup company Baebies has entered the second stage of Small Business Innovation Research funding from the National Institutes of Health ...
FIU Researchers Show Value of qPCR to Evaluate PCR Inhibition, Improve STR Amplification - 09/11/2014
Using Promega's quantitative PCR and short tandem repeat amplification kits, researchers at Florida International University recently characterized the changes in melt curves ...
UCSB Team Uses Computer CPU as Thermocycler; Eyes Low-resource MDx Applications - 09/11/2014
Researchers at the University of California, Santa Barbara have developed a new PCR platform for low-resource settings that utilizes heat generated by a personal computer to perform ...
New Zealand Startup Ubiquitome Launches Handheld qPCR Device, Claims True Field Operability - 09/04/2014
New Zealand-based startup Ubiquitome, a spinout of the University of Otago, has launched a handheld qPCR platform. Called Freedom4, the battery-operated, fieldable device can run four ...
UCLA Lab Wins NIH Funds to Validate Gonorrhea 'Superbug' Test - 09/04/2014
In the hope of preventing gonorrhea from becoming the next antimicrobial-resistant "superbug," researchers at the University of California, Los Angeles have been awarded a two-year, $270,000 ...
UPMC Researchers Get Funding to Study Link between Pesticides and Parkinson's Disease - 08/28/2014
Researchers at the University of Pittsburgh Medical Center have received funding to begin translating animal studies linking environmental toxin exposure and Parkinson's disease pathology ...
New Method Uses Input Sample Quantity to Eliminate Need for Control Genes in qPCR - 08/27/2014
Scientists at the State University of New York's Downstate campus have published a method that could obviate the need to measure control, or housekeeping, genes in quantitative PCR. Using ...
Independent Study Validates Simplexa Dengue Test as Focus Diagnostics Expands Menu - 08/14/2014
An independent study by researchers in Indonesia has shown that Focus Diagnostics' Simplexa Dengue test has a higher detection rate than conventional RT-PCR or SYBR Green real-time RT-PCR ...
Biofortuna Expands Dried PCR Reagents Business Citing Increased Demand from Dx Clients - 08/14/2014
Citing increased demand from companies outsourcing freeze-drying of diagnostic kits, molecular diagnostics firm Biofortuna has expanded its PCR reagent lyophilization production service. ...
DxTerity Diagnostics Launches Sample Collection and Assay Kits; Aims to Drive Down LDT Costs - 08/07/2014
DxTerity Diagnostics has begun commercializing blood sample collection products and a multiplex PCR reagent kit. The Los Angeles-based company displayed its product lines, called DxCollect ...
BD Launches DIY Reagent Kit for LDTs on BD Max System; Continues to Scale Up MDx Offerings - 08/07/2014
Becton Dickinson's BD Diagnostics division announced this week the launch of the Total Nucleic Acid suite, a kit of reagents to enable DNA- and RNA-based assay development ...
Abbott Previews Iridica Platform, Describes a Growing Molecular Business - 07/31/2014
Abbott continues to grow its molecular product line, previewing the next generation of its pathogen identification platform at the American Association for Clinical Chemistry annual meeting ...
Bio-Rad to Ship ddPCR Automated Droplet Generator in September - 07/31/2014
Bio-Rad has developed an automated droplet generator for its droplet digital PCR platform and plans to begin shipping the add-on in September. Unlike the current manual droplet ...
Quidel to Unveil Two New MDx Platforms at AACC as Company Ramps Up Molecular Business - 07/24/2014
Quidel said this week that it will officially unveil two new molecular diagnostic systems at the American Association of Clinical Chemistry annual conference and expo in Chicago next week. ...
Study Finds that Cepheid's GeneXpert TB Test Performs Poorly On Extrapulmonary Samples - 07/24/2014
Although the GeneXpert MTB/RIF assay from Cepheid is endorsed by the World Health Organization for diagnosing tuberculosis from expectorated sputum samples, its ability to detect TB in samples ...
Startup Behavioral Diagnostics Wins SBIR Grant to Develop Smoking Cessation Methylation Assay - 07/24/2014
Iowa City-based Behavioral Diagnostics recently won a one-year, $200,000 Small Business Innovation Research grant from the National Institute on Drug Abuse to fund development of its ...
Islet Sciences to Develop Diabetes Diagnostic Using Droplet-based Digital PCR - 07/17/2014
Islet Sciences, a Raleigh, NC-based biopharmaceutical company, said yesterday that its collaborators at Yale University School of Medicine have published key data demonstrating ...
Lucigen Enters Phase II of Grant for POC Hemorrhagic Fever Test; Targets C. diff, Pig Pathogen MDx - 07/17/2014
Lucigen has entered phase two of a five-year, $1.7 million, Small Business Innovation Research grant from the National Institute of Allergy and Infectious Diseases to develop a nucleic ...
Abbott's PCR/ESI-MS System Detects Rare Anaerobic Bacterium; Next-Gen Platform Under Development - 07/10/2014
A recent case study has shown the utility of combined PCR/electrospray ionization mass spectrometry (PCR/ESI-MS) for detecting a rare pathogen in a case of meningitis. ...
New Rapid RT-PCR Assay Detects All HIV-1 Groups - 07/10/2014
As part of a larger project aimed at producing a handheld molecular diagnostic for use in the developing world, researchers at Dartmouth have developed an assay to rapidly and reliably ...
Study Shows that ddPCR for Clinical CMV Monitoring has Potential but is Premature - 06/26/2014
Virologists at the University of Washington and the Fred Hutchinson Cancer Research Center recently reported that in a small, retrospective study droplet digital PCR appeared to have ...
Chinese Scientists Publish New Isothermal miRNA Detection Method with Point-of-Care Potential - 06/26/2014
A Chinese team has published the details of an isothermal nucleic acid amplification method for highly sensitive microRNA detection. According to the investigators from the State Key ...
With FDA-Cleared Flu Test, Alere Launches Isothermal MDx Platform for US Clinical Market - 06/19/2014
This week, Waltham, Mass.-headquartered medical diagnostics company Alere received FDA clearance for a new influenza test that can both detect and discriminate nucleic acids ...
New Method Combines Cell Sorting, ddPCR to Determine Plasmid Copy Number - 06/19/2014
Plasmids are a simple system for producing recombinant proteins, but variability in the number of plasmid copies per cell limits expression. Now, researchers in Germany have developed a method ...
Study Unveils New Method for Universal Extraction and PCR Amplification of Fungal DNA - 06/12/2014
A team led by researchers at the University of Texas Health Science Center in San Antonio has developed a new method of extraction and amplification for fungal DNA, creating a tool ...
Rice Team Develops Technique to Make Isothermal RPA Quantitative - 06/12/2014
To measure HIV viral load, researchers at Rice University in Houston have developed a technique that takes isothermal recombinase polymerase amplification, or RPA, to the next level. ...
Sysmex Inostics, Merck Aim for 2015 CE Mark for ctDNA Kit for Metastatic Colorectal Cancer - 06/05/2014
In a deal signed ceremoniously at the American Society of Clinical Oncology meeting earlier this week in Chicago, Merck and Sysmex Inostics will collaborate to develop and commercialize ...
Q&A: University of Cambridge Researchers on a Roadmap for Patenting Microfluidic Devices - 06/05/2014
Microfluidic devices have the potential to revolutionize PCR and molecular biology, in general. They promise to bring hand-held diagnostics to the developing world and save lives. But what is the best way to get ...
Dutch Group Develops RPA-based Assay for Leptospira - 05/29/2014
Researchers at The Royal Tropical Institute in Amsterdam have developed a novel isothermal recombinase polymerase amplification assay for pathogenic Leptospira , the spirochete bacterium ...
Abbott's Plex-ID Outperforms RT-PCR and Microarrays in FDA Viral ID Study - 05/29/2014
Scientists at the US Food and Drug Administration Division of Viral Products have demonstrated the limits of detection of different virus discovery tools, and recommended that they be used ...
German Researchers Make Mutant Polymerase for Mismatch Discrimination, Set to Launch Company - 05/22/2014
Biochemists at the University of Konstanz in Germany have created a mutant polymerase with high activity and high mismatch extension selectivity. The new enzyme is a variant ...
UPenn Team Receives NIAID Award to Develop LAMP-based Point-of-care Dx for Parasitic Helminths - 05/22/2014
Parasitic worm infections remain a difficult-to-detect neglected tropical disease, in part because the most sensitive diagnostic methods require a molecular biology lab. Now, ...
Q&A: Courtagen's Kevin McKernan on Skirting Sequencing Gene Patents With Novel PCR Methods - 05/15/2014
As CSO of Woburn, Mass.-based genetic testing firm Courtagen, Kevin McKernan recently co-authored a pair of papers with other Courtagen scientists describing novel PCR methods that he hopes ...
PositiveID Developing Handheld PCR for Space, Biodefense with Eye Toward Clinical Apps - 05/15/2014
Biodetection and biodefense company PositiveID recently announced a number of research awards and partnerships, including with the US Defense Threat Reduction Agency and NASA, which it is using to develop its handheld microfluidic PCR device, called Firefly Dx ...
Australian Team Develops Melt Curve Methylation Assay for Fragile X Detection, Potential Screening - 05/08/2014
Scientists at the Murdoch Childrens Research Institute at the Royal Children's Hospital in Melbourne, Australia, have developed an assay combining the qualitative strengths ...
Life Science Sales Boost Bio-Rad Q1 Revenues; Firm Details Droplet-based Sequencing Tech Investment - 05/08/2014
Bio-Rad this week reported a net sales increase of 3 percent in its Life Science segment in the first quarter versus the same period last year. Amounting to nearly 5 percent ...
University of Rochester Group Develops Open Source Algorithm for qPCR Non-detects - 05/01/2014
Sometimes qPCR data is simply missing. It is standard practice in data processing to replace "non-detects," or reactions failing to produce a minimum amount of signal, with a cycle threshold ...
UW Madison Group Wins NCI Funding for Microfluidic Device to Aid CTC Analysis - 05/01/2014
A group at the University of Wisconsin, Madison recently received a five-year grant totaling approximately $1.5 million from the National Cancer Institute to develop a microfluidic chip that will combine circulating tumor cell purification, DNA and RNA extraction, and protein analysis ...
German Engineering Firm Bosch Developing Microfluidics Platform for PCR - 04/24/2014
A series of papers published in the past three months has demonstrated a novel microfluidics platform for PCR assay automation being developed in part by Bosch, a Stuttgart, Germany-based ...
FDA Researchers Describe Inexpensive Reagent Enabling RT-qPCR of Crude Cell Lysate - 04/24/2014
Scientists at the US Food and Drug Administration's Office of Vaccines Research and Review have developed a simple, inexpensive, cell lysis buffer for use in cell cultures to generate crude ...
Study Highlights Non-invasive Breast Cancer Biomarker Panel Using cfDNA Methylation - 04/17/2014
A study published this week has shown methylation status in a panel of genes may be useful to non-invasively monitor breast cancer recurrence and treatment response. The two-step multiplex ...
To Push Extreme Speed Limits of PCR, Utah Researchers Characterize Polymerases - 04/17/2014
In an effort to discover all factors constraining the speed of polymerases in the PCR reaction, a University of Utah group headed by Carl Wittwer has developed a fluorescent probe to monitor polymerase activity. ...
Study Compares Bisulfite Conversion Kits from Analytik Jena, Qiagen, Zymo for Methylation Analyses - 04/10/2014
With numerous kits on the market for PCR of methylated DNA, researchers may wonder which is the best for bisulfite conversion of various types of real-world samples. A study published this week in PLoS One ...
Researchers Perform PCR on DNA Bound to Single-walled Carbon Nanotubes - 04/10/2014
Researchers at West Virginia University have begun to elucidate the parameters for PCR of DNA interacting with single-walled carbon nanotubes. In exploratory research published in PLoS ONE this month, ...
Incubated by Singapore's AITbiotech, Phoenix Molecular Developing Handheld PCR Device - 04/03/2014
Singapore-based molecular diagnostics and genomic services firm AITbiotech recently spun off a new division called AITventures to commercialize life science technology and diagnostics. Funded ...
Toledo Group Publishes Method for Multiplex RT-qPCR Lung Cancer Dx from FFPE - 04/03/2014
A team at the University of Toledo Health Sciences Campus in Ohio has developed a multiplexed method for two-color fluorometric, real-time, reverse transcriptase qPCR from formalin-fixed, paraffin-embedded fine ...
Methylation-Specific PCR Helps Uncover Potential cfDNA Biomarker for Lung Cancer Prognosis - 03/27/2014
Assessing epigenetic silencing of a metastasis-suppressing gene in cell-free DNA provides prognostic information for non-small cell lung cancer, according to a recent study led by researchers from the University ...
Paper Details New Pre-PCR Method for STR Analysis of Forensic Samples - 03/27/2014
An Australian duo has developed a pre-PCR technique to improve results in forensic DNA analysis. The method, published this month in BioTechniques , is designed to eliminate stochastic sampling effects ...
German Group Develops Dipstick Dx for Malaria Using Isothermal RPA Tech - 03/20/2014
A team at the University of Potsdam and the Fraunhofer Institute for Biomedical Engineering (IBMT) in Germany has developed a lateral flow assay to detect P. falciparum parasite, the most deadly ...
Harvard, Akonni Partnership Wins $29M to Develop Drug-resistant Tuberculosis Diagnostic - 03/13/2014
Harvard University and Akonni Biosystems have teamed up to develop and test an amplification array-based diagnostic for multi-drug-resistant and extreme-drug-resistant tuberculosis. The work is one of several ...
Study Shows Clinical Utility of qPCR for Common Viruses in Children with Acute Respiratory Illness - 03/13/2014
With high hopes of slowing antibiotic resistance development, researchers at Karolinska University Hospital in Stockholm have demonstrated clinical utility of a qPCR assay for 16 viruses considered ...
German Team Details RT-qPCR Assay to Detect ALK Rearrangements from FFPE - 03/06/2014
A team of researchers in Germany has developed a new assay to help determine which non-small cell lung cancers are likely to respond to certain targeted therapies. As a screen for gene rearrangements, ...
BU Lab Developing POC Dx for Whooping Cough using Lateral Flow, Blister-pack Reagents - 03/06/2014
Packaging isothermal PCR reagents in blisters and using lateral flow detection, researchers at Boston University hope to develop a low-cost, disposable assay for Bordetella pertussis , the causative agent ...
Q&A: UMich's Muneesh Tewari on miRNAs as Cancer Biomarkers, ddPCR as Detection Method - 02/27/2014
Muneesh Tewari , a former Fred Hutchinson Cancer Research Center scientist who recently moved to the University of Michigan, has taken a special interest in microRNAs and their potential as biomarkers ...
Wave 80 Receives SBIR Grant to Develop No-spin Sample Prep for Chlamydia MDx - 02/27/2014
Molecular diagnostic company Wave 80 Biosciences has received Phase I Small Business Innovation Research funding from the National Institutes of Health to develop rapid sample prep to support chlamydia testing ...
Dana-Farber Researchers Use ddPCR for Noninvasive Detection of Cancer Treatment Response - 02/20/2014
Genotyping cell-free DNA and circulating tumor cells can provide a useful measure of cancer treatment response up to 16 weeks prior to standard clinical measures, according to a study from a group ...
New Multiplex qPCR Assay Measures mtDNA Copy Number, Aging-related Deletions - 02/20/2014
Researchers at the University of North Texas Health Science Center recently developed an assay capable of quantifying nuclear DNA, mitochondrial DNA copy number, and the ratio of age-related deletions ...
At Threshold of Detection, False-Positive Droplets a Nuisance in ddPCR - 02/13/2014
Quantifying HIV levels in patients on antiviral therapy demands assays able to function well in the lowest ranges. ...
Korean Team Develops Microfluidic Chip Integrating RNA Extraction, cDNA Synthesis, and Amplification - 02/06/2014
Researchers at Inje University in South Korea have developed a microfluidics-based chip that integrates three PCR needs into one device. The chip, which is about the size of a microscope slide, performs ...
Scripps Team Creates High-Fidelity Unnatural Base Pair with Eye Toward Biologics - 01/30/2014
Work published recently by a Scripps Research Institute team has advanced the field of synthetic nucleic acids, demonstrating an unnatural base pair palatable to DNA replication machinery under standard PCR conditions, ...
Analytik Jena Launches Polymer-mediated Extraction Kit for cfDNA - 01/23/2014
German company Analytik Jena has launched a kit for enrichment and extraction of circulating cell-free DNA, which it believes is quicker than currently commercially available products, requiring fewer steps as well as lower ...
EKF's DNA Enrichment Tech Enables Cancer Biomarker Detection in Preliminary Study - 01/23/2014
Preliminary results from a collaboration between EKF Molecular Diagnostics and researchers at Swansea University in Wales have demonstrated that EKF's PointMan DNA enrichment technology may enhance detection ...
Dutch Group Validates New HPV Test; Shows Self-, Clinician-collected Samples Comparable - 01/16/2014
Persistent infection with high-risk strains of human papillomavirus can cause cervical cancer, and uninfected individuals have a low risk of developing the disease. As such, validating assays purporting ...
Co-Diagnostics Claims 2.5M-fold Reduction in Non-specific Amplification with New Primer Tech - 01/16/2014
During PCR, if primers begin to amplify each other it can kick off a propagating reaction, threatening to swamp out PCR signal and leading to false negative results. Hot-start PCR can reduce the problem somewhat, but so-called primer-dimers ...
Purigen Biosystems Wins SBIR Funding to Develop Isotachophoresis Chip for Nucleic Acid Prep - 01/09/2014
Purigen Biosystems , a Bay Area biotech company founded in 2012, recently received $150,000 in Phase I Small Business Innovation Research funding from the National Institutes of Health to develop a device ...
Biological Dynamics Looks to Commercialize cfDNA Sample Prep through CLIA Lab, Partners - 01/02/2014
Biological Dynamics , a five-year-old startup in San Diego, Calif., recently received a US patent for a device that uses a dielectrophoretic microelectrode microarray to quickly purify circulating cell-free ...
German Team Publishes Modified qPCR Method to Quantify DNA Damage in Nuclear, Mitochondrial Genomes - 01/02/2014
A recently published study has demonstrated the advantages of a modified real-time PCR-based technique for quantifying DNA damage. The authors claimed the new method, called long-run real-time DNA-damage ...
Recent Studies Demonstrate Potential of ddPCR to Detect Circulating microRNA for Lung Cancer Dx - 12/19/2013
While cancer's microRNA signature continues to yield to scientific scrutiny, tricky sample prep and the limitations of qPCR have hampered use of miRNA expression patterns as non-invasive biomarkers. A pair ...
ASU Lab Develops Emulsion-based Continuous Flow Droplet qPCR for the Deep Sea and Beyond - 12/12/2013
Arizona State University researchers recently published the details of an emulsion-based droplet qPCR platform believed to be the first ever to enable real-time analysis on a continuous-flow system. ...
Using $15M DARPA Award, Caltech Team Shows Robust Digital Isothermal PCR on 'SlipChip' Device - 12/05/2013
Using a microfluidic device called SlipChip, a cell phone camera, and cloud computing, a California Institute of Technology team has shown the superiority of digital over real-time isothermal PCR under perturbed ...
Mobile PCR Lab in Rural Cambodia Detects Asymptomatic Malaria Infection with Eradication in Mind - 11/21/2013
In Cambodia's Ratanakiri Province , main roads project like spokes from the small city of Banlung, population 17,000. Here, next to the local health department, a team of Cambodian and Belgian researchers intent ...
SBIR Funds in Hand, DxTerity Developing Radiation Toxicity Predictor Using Chemical Ligation Probes - 11/14/2013
Molecular diagnostics company DxTerity Diagnostics was recently awarded a $280,000 Small Business Innovation Research contract from the National Cancer Institute to develop a test for susceptibility ...
New Method Uses Simple Fixes to Increase PCR Yields from FFPE Samples - 11/07/2013
Ramping up concentrations of polymerase and dNTPs, and lengthening reaction time in PCR on formalin-fixed paraffin-embedded samples overcomes common barriers to detection, according to recently published ...
Dx Startup DiaCarta Launches Mutation Detection Assays Using 'QClamp' Xenonucleic Acid Tech - 10/31/2013
DiaCarta, a four-year-old Bay Area startup eyeing point-of-care diagnostics, said this week that it has commercially launched a line of real-time PCR test kits for somatic mutations linked to cancer. Called ...
Study Finds Pooled Nucleic Acid Testing in Vancouver Clinics Reduces HIV Spread - 10/17/2013
A combination of pooled nucleic acid testing and social marketing improved early diagnosis of HIV infection in men who have sex with men in Vancouver, according to research published this week. A team led ...
Diagnovus Launches Real-Time PCR Assay to Gauge Barrett's Esophagus Cancer Risk - 10/10/2013
Molecular diagnostics company Diagnovus this week launched a real-time PCR-based assay to measure a patient's risk of developing a specific type of esophageal cancer from the condition Barrett's esophagus. ...
