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

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

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 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.

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

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

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.

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

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

The false negative rates do not appear out of line with the test's sensitivity figures, but issues have been raised with its workflow and the firm's marketing strategy.