The company has completed its FDA submission for the system and inked a deal with UAE-based healthcare provider Burjeel Holdings to deploy the system in its facilities.

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

Labcorp also becomes a referral lab for the system's seven hospitals and clinical labs and will open three new patient service centers.

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

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

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.

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

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

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.