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

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

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

360Dx regularly updates this tracker to provide readers with accurate information on the regulatory status of these tests in the US, European, and Asian markets.

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.

Cepheid's GeneXpert system displayed at a conference. NEW YORK – A decade ago, a molecular point-of-care test received CLIA waiver for the first time, ushering in what many thought would be a seismic ...

A colorized transmission electron microscope image of the SARS-CoV-2 virus. Part 1 of 2. NEW YORK – As the SARS-CoV-2 virus ripped through the world like a wildfire in early 2020, the US was desperate ...

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 Global Healthy Living Foundation and Guardant will raise awareness on the importance of early detection and highlight the growing range of accessible screening options. The Florida company's ...

NEW YORK – A US District Court's recent decision vacating the US Food and Drug Administration's final rule on laboratory-developed tests (LDTs) made clear that the agency does not have the legal ...