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FDA Clears Meridian's Group A Streptococcus MDx Test

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared for marketing Meridian Bioscience's Group A Streptococcus molecular diagnostic test that runs on its illumigene platform, the company said after the close of the market on Monday.

The test uses loop-mediated isothermal DNA amplification, or LAMP, technology to detect Streptococcus pyogenes in throat samples, and relies on a procedure that takes less than one hour, the Cincinnati-based company said, adding that all reagents and disposables are contained in the test kit and can be stored at room temperature.

"Illumigene Group A Strep is a significant addition to Meridian's illumigene menu, especially as it offers the advantage of both faster and more accurate strep throat diagnostic results," Meridian Chief Commercial Officer Rick Eberly said in a statement.

FDA clearance of the test follows clearance from the agency for two other tests run on the company's illumigene platform, one for C. difficile, cleared in July 2010, and the other for Group B Streptococcus, cleared in December 2011.

Three weeks ago, Meridian reaffirmed its 2012 guidance of EPS in the range of $.78 and $.81 on revenues of between $171 million and $175 million. It also provided fiscal 2013 guidance of between $190 million and $195 million in revenues, and diluted EPS of between $.86 and $.91 per share.