Diagnostics company bioMerieux (PARIS:BIM) has received 510(k) clearance from the U.S. Food and Drug Administration for a test to detect and screen for methicillin-resistant staphylococcus, more commonly called MRSA.
BioMerieux said that its automated molecular test, called NucliSENS EasyQ MRSA, detects seven MRSA types and covers the most prevalent strains. The advantage of molecular-based testing is faster results. BioMerieux claims its system can process up to 46 tests with a turnaround time of three hours. Conventional culture-based tests can take up to three days.
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“BioMerieux is committed to bringing innovative solutions to the microbiology lab that reduce the time to results so that clinicians can treat patients more rapidly,” CEO Stephane Bancel said in a statement.
With U.S. regulatory clearance on EasyQ, bioMerieux can offer clinicians molecular-based MRSA screening and culture-based screening through its chromID test. The chromID diagnostic received FDA clearance in 2009.
France-based bioMerieux, which has major operations in Durham, North Carolina, has been moving to expand its reach by going beyond medical diagnostics. The company last week announced it would acquire French microbiological analysis firm AES Laboratoire for $260 million, an acquisition that makes bioMerieux a lead player in food testing.
BioMerieux said that MRSA is responsible for an estimated 19,000 U.S. deaths a year. The company said that infection-control measures such as MRSA screening can cut MRSA rates by up to 50 percent.
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Other companies that have FDA-cleared molecular MRSA tests include Roche (OTC:RHHBY) and BD (NYSE:BDX).
