The automated real-time PCR test provides results in as little as 18 minutes.
The test leverages loop mediated isothermal amplification technology and enables the rapid detection of Neisseria meningitidis directly from cerebrospinal fluid samples.
The firm's in vitro diagnostic nucleic acid screening test performs direct detection of Babesia DNA and RNA in whole blood specimens from human blood donors.
The firm said that it will soon apply for a CLIA waiver of the second-generation test,which can report positive results in as little as five minutes
The firm said today that it has received all regulatory clearances to close the deal that it first proposed in February 2016.
Smaller labs, hospital outreach labs, and labs servicing high numbers of elderly are thought to face the highest risks.
The deal ends an investigation by the SEC into certain accounting practices by Alere's foreign subsidiaries. The company also consented to a cease-and-desist order.
Guardant is providing its Guardant 360 CDx test for a clinical trial of Merck's small molecule, c-Met kinase inhibitor called tepotinib.
Patients with PD-L1-expressing gastric or gastroesophageal junction tumors can now be identified for potential treatment with Keytruda using Agilent's assay.
The NIH is soliciting public comments on a planned update to its Genomic Data Sharing Policy that guides data management of genomic summary results.
Genetic profiles generated by Thermo Fisher's Yfiler Plus PCR amplification kit can now be included in the FBI's DNA indexing system.
The company's PD-L1 IHC 28-8 pharmDx diagnostic can now be used in cases of urothelial carcinoma and squamous cell carcinoma of the head and neck.
The thermocycler is a point-of-care diagnostic system that enables real-time molecular testing in hospitals, clinics, physician offices, and the field.
The kit detects 29 mutations in exons 18, 19, 20, and 21, and has a limit of mutation detection at .1 percent in a background of wild-type DNA.
The British-based firm says that its assay detects hepatitis C via a single-use, disposable cartridge within 90 minutes of testing.
The test, miRpredX 31-3p, is a positive theranostic test that quantifies the expression of miR-31-3p in FFPE using RT-qPCR technology.
The panel, developed by collaborator Janssen, is expected to improve detection of influenza and respiratory syncytial virus.
His time at OIVD was one of breakneck advancement in molecular diagnostics, to which the agency responded with regulatory action and efforts to reduce regulatory burden.
The software provides analysis of HLA typing by NGS on several platforms, including ones from Illumina, Thermo Fisher, and PacBio.
Based on iCubate's Amplicon-Rescued Multiplex PCR technology, the iC-GPC assay is the first of the company's portfolio's to earn CE mark.
The New York Times profiles 23andMe's Anne Wojcicki and describes how she bounced back from a bad year.
Fotis Kafatos, the founding president of the European Research Council, has died, according to the Associated Press.
In PLOS this week: genomic analysis of honeybee disease, microRNA profiles of people with lupus nephritis, and more.
The Verge's Angela Chen tried out a gene test for fitness advice, but didn't learn much new information.