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Sep 18, 2012

FDA Okays Meridian’s Strep Throat Diagnostic

  • FDA cleared Meridian Bioscience’s illumingene® molecular diagnostic test for Group A Streptococcus pharyngitis. The test, carried out on the illumigene molecular diagnostic platform, uses loop-mediated isothermal DNA amplification to detect Streptococcus pyogenes in throat samples, takes less than an hour to complete, and the kit includes all reagents and disposables that can be stored at room temperature.

    “Our diagnostic tests are specifically developed for faster and more accurate detection and early diagnosis of acute infectious disease-causing pathogens,” states Jack Kraeutler, CEO. “With illumigene Group A Strep, healthcare providers and patients can get a definitive strep throat diagnosis rapidly.”

    Meridian offers a broad range of diagnostic test kits, purified reagents and biopharmaceutical enabling technologies. The firm’s diagnostic portfolio includes tests for the early diagnosis of Clostridium difficile, Helicobacter pylori, foodborne diseases, and respiratory infections. 



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