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

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 ...