The US Food and Drug Administration (FDA) has granted 510(k) clearance to Quidel's non-instrumented molecular diagnostic assay, designed for the detection of toxigenic Clostridium difficile (C difficile) bacterial DNA. The AmpliVue C. ...
Tags: FDA, Non-Instrumented C Difficile Detection Assay, medical technology
The US Food and Drug Administration (FDA) has granted 510(k) clearance to Nanosphere's CYP2C19 nucleic acid test to determine gene variants affecting drug metabolism. The CYP2C19 enzyme, in general, metabolizes approximately 15% of all ...
Tags: FDA, CYP2C19 enzyme, automated sample-to-result Verigene system
Roche has introduced new CE certified IVD version of the MagNA Pure 96 system, designed for extracting nucleic acid. The MagNA Pure 96 system, which can purify a broad spectrum of human samples, provides laboratory information management ...
Tags: Roche, IVD version, MagNA Pure 96 system, nucleic acid, data transfer
The European Union has granted CE mark to Abacus Diagnostica's molecular diagnostic assay, designed for detecting toxin-producing Clostridium difficile. The GenomEra C. difficile assay, which is designed for use with the company's ...
Bio-Rad Laboratories has unveiled a new Digital Biology Center to develop new products for research and diagnostics markets. The first launched QX100 Droplet Digital PCR system will utilize the droplet partitioning technology to ...
Tags: Bio-Rad Laboratories, Digital Biology Center, PCR system, Bio-Rad Labs
US-based 3M Food Safety has achieved NF Validation mark for its Molecular Detection Assay Salmonella from AFNOR Certification. The Salmonella assay was among three pathogen test cases that the company unveiled, following the launch of its ...
The US Food and Drug Administration (FDA) has approved Roche's new COBAS TaqMan HIV-1 viral load test. The HIV viral load test utilizes the FDA-approved high pure system viral nucleic acid kit for manual specimen preparation and the COBAS ...
Tags: HIV-1 viral load test, COBAS TaqMan, FDA
Illumina system used in faster genome sequencing 08 Oct 2012 A sequencing protocol using a rapid-throughput platform could help diagnose critically ill infants. Faster sequencing Investigators at Kansas City's Children's Mercy ...
Tags: Illumina system, Science Translational Medicine, test, health
Biocartis in Switzerland has introduced a new proteomic and nucleic acid platform for high-quality biomarker analysis. Using semi-conductor technologies and micro-fluidics, the new Dynamic Multi-Analyte technology (DMAT) analyzes several ...
Tags: Biocartis, proteomic and nucleic acid, biomarker analysis
Lab21 has entered into a collaboration agreement to develop polymerase chain reaction-based assays on BD Diagnostics' automated BD MAX molecular system for a series of oncology markers. The two assays, which will be initially developed, ...
Tags: Lab21, collaboration agreement, BD Diagnostics, reaction-based assays
The US Food and Drug Administration (FDA) has granted de novo petition to market Nanosphere's gram-positive blood culture nucleic acid test (BC-GP) on the automated sample-to-result Verigene system. Single automated BC-GP test detects ...
Tags: Nanosphere, FDA, BC-GP test, Verigene system
Quest Diagnostics has received FDA 510(k) clearance for its Simplexa C difficile Universal Direct Test on the 3M Integrated Cycler. The test, which uses a proprietary chemistry that eliminates the need for nucleic-acid extraction, is ...
Tags: Quest Diagnostics, 3M integrated cycler, Simplexa tests
Roche has gained FDA approval for the new HIV viral load test, the COBAS TaqMan HIV-1 Test, v2.0, and will launch the product in the US, later in 2012. The COBAS TaqMan HIV-1 Test, v2.0, targets two highly conserved regions of the HIV-1 ...
Enzo Biochem, a molecular diagnostics company, has introduced the ColonSentry blood-based risk stratification test to assess a patient's risk of having colorectal cancer. ColonSentry requires a small blood sample and utilizes RNA to ...
Tags: Enzo Biochem, ColonSentry blood-based risk stratification test
Sequella has licensed its B-SMART technology to Laboratory Corporation of America (LabCorp) to allow LabCorp to develop a new laboratory-based antibiotic susceptibility assay for Mycobacterium tuberculosis and to use the assay in the US ...
Tags: LabCorp, B-SMART technology, Sequella