The new financial agreements include $5 million of new term-loan proceeds to strengthen liquidity and funding for continued investment in product development.

The US Food and Drug Administration cleared a number of molecular tests and immunoassays, as well as a clinical chemistry and a cellular deformation test.

NEW YORK – Fulgent Genetics announced on Monday that it has entered into a definitive agreement to acquire lab service provider StrataDx, as well as certain assets of Bako Diagnostics. Fulgent said it ...

Abbott's Exact Sciences buy, Blackstone and TPG's Hologic acquisition, and Water's BD transaction could herald a busy 2026 for diagnostics deals, observers said.

The deal gives clinicians in PathNet's national lab network access to Valar's AI-powered Vesta diagnostic portfolio for non-muscle invasive bladder cancer.

The digital revolution is now more quickly transforming pathology lab workflows, pointing towards accelerating adoption in the coming years.

In 2023 the institute was also deemed an EU reference lab for high-risk IVDs for the detection of hepatitis viruses, retroviruses, and respiratory viruses.

Last week, readers were most interested in a story about the reasons behind the rapid adoption of BioMérieux's SpotFire syndromic qPCR instrument.

Approaches incorporating rapid or digital PCR, CRISPR, syndromic testing, and multimodal systems reached new milestones this year.

Launched less than three years ago, the system may be changing how point-of-care tests are used in doctor's offices and emergency rooms.

NEW YORK – As 2024 closed, the US Food and Drug Administration had — much to the chagrin of clinical labs — at last made good on its decades-long promise to regulate laboratory-developed tests (LDTs), ...

The goal of the proposal is to "streamline and future-proof" the IVDR, particularly to relieve the burden on small- and medium-sized enterprises.