NEW YORK (GenomeWeb News) – AdvanDx today said that it will offer Inverness Medical Innovations' BinaxNow PBP2a test in the US.
The test, which is an antibody-based rapid immunochromatographic membrane assay, received 510(k) clearance from the US Food and Drug Administration last month.
The test rapidly detects penicillin-binding protein 2a present in methicillin-resistant Staphylococcus aureus directly from S. aureas-positive blood cultures. Conventional methods of susceptibility testing can take 24 hours, and mecA gene identification is expensive and time-consuming, AdvanDx said in a statement.
In clinical studies, the test demonstrated 97.1 percent positive agreement and 100 percent negative agreement with conventional methods of testing for MRSA, AdvanDx said.
Combining S. aureus identification from PNA FISH and "reflexing to PBP2a" detection in MRSA with the BinaxNow test will allow AdvanDx to "offer a unique, cost-effective, and easy-to-use solution" that will enable laboratories to provide accurate test results one day sooner than with conventional methods, the company said.
The company, which has offices in Woburn, Mass., and Vedbaek, Denmark, provides molecular diagnostic products for diagnosing and treating bloodstream infections.