The Florida company's Kiffik K-Exp platform enables continuous access to interstitial fluid for longitudinal molecular diagnostic testing.

Last week, readers were most interested in a story about concerns among some clinicians around BillionToOne's Unity NIPT due to false negative results.

Readers this past year were most interested in a story about the FDA abandoning its plans to regulate LDTs after a court struck down its efforts.

The assay is the first to receive FDA 510(k) clearance and CLIA waiver for use with Diasorin's Liaison Nes platform.

The SD Biosensor Standard Q COVID-19 Ag Test and Acon Biotech Flowflex SARS-CoV-2 Antigen Rapid Test were previously listed under WHO's emergency use listing.

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 ...

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.