Meridian Bioscience receives FDA approval for Shiga-detecting test
Rapid diagnostic tool is first to distinguish between Shiga toxin producing E. coli and other 0157 strains; partnership with Merck pays off; only twenty minures needed to make a diagnosis
The fight against the evil E. coli marches on. Cincinnatti, Ohio-based Meridian Bioscience, announced this week that it had received FDA approval for its ImmunoCard STAT! EHEC rapid diagnostic test — the first, the company said, capable of differentiating between Toxin 1 & Toxin 2. The ImmunoCard STAT! EHEC comes in the wake of new Centers for Disease Control (CDC) recommendations that laboratories use a test that detects all Shiga toxin producing E. coli (which can cause bloody diarrhea and lead to kidney failure in children or people with weakened immune systems) and not just a test that detects the more general class of O157 E. coli strains. The test is also the first product to come out of the strategic partnership announced in August 2006 between Meridian and Darmstadt, Germany-based Merck KGaA and EMD. “The launch of ImmunoCard STAT! EHEC further solidifies Meridian’s position as a leader in the field of E. coli testing,” said company COO John Kraeutler.
-read more in this company news release
