AdvanDx won 510(k) clearance from the Food & Drug Administration for a rapid diagnostic designed to detect staphylococcal pathogens in the bloodstream in 90 minutes.
The Woburn, Mass.-based diagnostics maker said the FDA cleared its S. aureus PNA FISH and S. aureus/CNS PNA FISH tests, claiming they cut down turn-around times by an hour by reducing probe hybridization times. Staph bacteria are the most prevalent cause of bloodstream infections and blood culture contamination, according to the company.
It’s the second 510(k) nod for an AdvanDx bloodstream pathogen test in recent months. Its E. faecalis/OE PNA FISH test for enterococcal bacteria got the green light in October.
AdvanDx pulled in $8 million in a Series C round in August from a pair of existing investors, SLS Venture and LD Pensions.
