Aptitude's Next-Gen Metrix COVID Test Wins First 510(k) Clearance
The updated Metrix molecular diagnostic moves from emergency use to traditional FDA clearance, with higher sensitivity and faster results.
The FDA has granted Aptitude a 510(k) clearance for the next-generation Metrix COVID diagnostic, the company's first such clearance for the platform. The original Metrix test had been authorized under an emergency use authorization.
According to Aptitude, the updated test is about three times more sensitive than the earlier version and produces results roughly 30% faster. The clearance specifically covers the Metrix molecular diagnostic for COVID.
The 510(k) clearance shifts the product from the temporary emergency use pathway to a standard regulatory status, giving it a more durable footing in the market. The reported figures come from a single source, with no independent data cited.
More in Medicine & Biotech
Ebola Vaccine Trial Launches in DR Congo Outbreak Zone
Health workers in DR Congo have begun testing whether a vaccine designed for a different Ebola strain can protect against the current outbreak.
Beacon Gene Therapy for Rare Vision Loss Succeeds in Pivotal Trial
A pivotal trial of Beacon Therapeutics' gene therapy for X-linked retinitis pigmentosa improved visual acuity, clearing the path toward an FDA submission.
Alkermes orexin agonist shows early promise for ADHD
Early-stage data suggest Alkermes' orexin agonist could expand the drug class beyond sleep disorders into ADHD.
Telix to Buy ITM for $1.65B, Challenging Novartis in Radiopharma
The acquisition gives Telix a late-stage pipeline and supply network that could compete with Novartis' Lutathera.