The agency cleared the automated qualitative IVD test last month for the detection of the toxin B gene of toxigenic Clostridium difficile.
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 funding will be used to pay for clinical trials in the US that will be used as underlying evidence for FDA clearance of the test, the company said.
The PCR-based test can simultaneously detect for the Zika virus, all serotypes of the dengue virus, the chikungunya virus, the West Nile virus, and a host gene.
The iC-System is based on on iCubate's amplicon-rescued multiplex PCR technology, which detects multiple pathogens simultaneously.
The US Food and Drug Administration yesterday granted emergency use authorization to Thermo Fisher Scientific's TaqPath Zika Virus Kit.
The new version of the mass spectrometry-based system adds 144 microbial species to its database and includes new tools for sample preparation.
NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in Korea, while envisioning a 2019 submission to the US FDA.
The firm said that the RealTime CMV test is the only commercially available cytomegalovirus that can amplify two select regions of the CMV genome.
China may include regulations protecting genes and embryos in its update of its civil code, Nature News reports.
23andMe and Airbnb have partnered to offer "heritage travel," according to Venture Beat.
In Nature this week: exome sequence analysis of individuals with type 2 diabetes, genomic prediction of maize yield across environments, and more.
NPR reports on efforts to engineer bacteriophages to destroy antibiotic-resistance bacteria.