The firm said that it has completed clinical trials for the Group B Strep assay for the FDA and will start trials for the C. difficile test this month.
The Hereditary Cancer Solution combines target capture probes from Integrated DNA Technologies with specialized analytics developed by Sophia.
The test combines two previously CE marked assays that are based on the company's Nucleosomics platform for identifying and quantifying nucleosome structural features.
The combination of the new test with Biocartis' existing KRAS assay offers customers a complete solution for testing metastatic colorectal cancers as reccomended by professional guidelines.
The next-generation sequencing-based test is designed to detect bacteria and viruses in blood samples from patients with suspected infections, especially immunocompromised patients.
The assay uses loop-mediated isothermal amplification to directly detect Streptococcus agalactiae infection, a common cause of neonatal meningitis.
The real-time PCR-based test runs on the BD Max system and comes in a single tube that snaps into the BD MAX extraction cartridge.
Roche said it will offer the microarray-based Harmony IVD kit and Ariosa Cell-Free DNA System (AcfS) software to laboratories outside the US.
Pisces will market and sell WaveSense's products, including its EpiSep platform and bead-based CD138+ cell isolation technology, in Ireland and the UK.
The approval also covers the company's magnetic bead technology for isolation of CD138-positive cells, which it plans to commercialize in Europe.
In PNAS this week: carbapenem resistance in Enterobacteriaceae, selection against educational attainment-linked variants, and more.
Technology Review points out that a new US presidential science advisor hasn't been selected.
Researchers find that blood tests might be able to help determine severity of a concussion, Wired reports.
President-elect Donald Trump considers other candidates for director of the National Institutes of Health, Nature News reports.