The rapid molecular chlamydia and gonorrhea self-test provides results in 30 minutes from a self-collected swab sample, the firm said.

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

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

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.

NEW YORK – Finnish diagnostics company Uniogen is on track to seek a CE-IVD mark for an early-stage ovarian cancer detection test by 2027. Currently available for research use only, the firm's Glyvar ...

NEW YORK — Computational imaging firm Macula Vision Systems said Thursday that it has raised $1.7 million in seed funding for the commercialization of its MVS Epsilon infectious disease microscopy ...

NEW YORK – Roche said Thursday that it has secured the CE mark for its mass spectrometry assay kit for antibiotics drug monitoring. With the approval, the company's automated clinical mass spec system ...

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 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 – With its $275 million buy of Foresight Diagnostics announced last week, Natera plans to expand into the hematological oncology market and boost sensitivity of its flagship Signatera solid ...

NEW YORK — Quanterix said Wednesday that it and its Lucent Diagnostics brand have struck an exclusive deal for the distribution of its Simoa platform for blood-based Alzheimer's disease testing in ...