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Meridian Bioscience gets FDA nod for molecular C. difficile test

3:02 pm by | 0 Comments

Diagnostics company Meridian Bioscience Inc. (NASDAQ: VIVO) has received the go-ahead from the Food and Drug Administration to sell its first molecular test — illumigene C. difficile.

Over the years the Cincinnati life science company has gotten good at making diagnostic test kits that detect bugs like C. difficile, which is a bacterium that can cause diarrhea and, in severe cases, a life-threatening inflammation of the colon.

Its illumigene testing system detects the presence of the toxin-producing region of the C. difficile DNA within an hour. Already launched in Europe, illumigene C. difficile uses an amplification technology that makes it easier and less expensive to use than some other molecular tests in the fast-growing market for rapid test kits.

“The first platform of C. difficile … is capable of producing somewhere in the range of $10 million to $20 million annually,” Jack Kraeutler, Meridian’s chief executive, said during a January interview. “The second generation of illumigene, which will probably start to go into clinical trials later this fiscal year, should be able to do even more than that.”

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The new testing platform augments — not replaces — the immunoassays the company already sells.

“Some years ago, Meridian recognized that its infectious disease lab customers may require molecular amplification capabilities in specific instances,” Kraeutler said in a Tuesday release. “Our goal has been to deliver the power of molecular amplification in a platform that is simple, highly cost effective and accessible for any of our lab customers.

“With the introduction of illumigene C. difficile, we have achieved the first step toward that goal,” he said. “We will be expanding the test menu for this exciting new platform.”

Meridian shares were up $1.24, or 7 percent, to $18.76 in mid-afternoon trading on the Nasdaq Stock Market.

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Mary Vanac

By Mary Vanac

Mary Vanac is a co-founder of MedCity News.
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