Last week, readers were most interested in a story about how the FDA could exert authority over LDTs in the future.

The company, also known as DRW, shared early data on its forthcoming multiplex qPCR-based platform and infectious disease ...

The firms are developing a workflow that will include Cepheid's sample and library preparation, nanopore sequencing, and automated data analysis.

VIENNA – Irish researchers presented data Saturday at the European Society of Clinical Microbiology and Infectious Diseases ...

Bruker said the investment will increase its capabilities in small molecule clinical diagnostics, including in therapeutic drug monitoring and other applications.

The agency could continue to pursue more extensive LDT oversight by tightening control over items like RUO reagents and specimen collection devices.

The PD-L1 IHC 22C3 PharmDx (Code SK006) assay is now certified for use to aid treatment decisions for patients with gastric or gastroesophageal junction adenocarcinoma.

The firm is developing a kitted version of the four-biomarker combination test, and it plans to commercialize them in the EU and US markets.

The US Food and Drug Administration granted clearances for testing instruments, a blood clot drug companion diagnostic test, and infectious disease tests, among other devices.