Devices & Diagnostics

Meridian Bioscience gets FDA clearance for molecular group B strep test

Diagnostic test maker Meridian Bioscience (NASDAQ:VIVO) has received regulatory clearance of a molecular diagnostics test […]

Diagnostic test maker Meridian Bioscience (NASDAQ:VIVO) has received regulatory clearance of a molecular diagnostics test for group B streptococcus.

The group B strep test is the second in the Cincinnati-area company’s illumigene line of molecular diagnostic tests to be cleared by the U.S. Food and Drug Administration. The illumigene product line is key to Meridian’s future as more customers look to molecular diagnostics, a means of analyzing the makeup of an organism at the genetic level.

Meridian says the illumigene platform provides its hospital and laboratory customers with a simpler, cheaper option to test samples for certain types of bacteria without the use of expensive instrumentation. Meridian’s first illumigene test, for the bacterium C. difficile, received FDA approval in July 2010.

The new group B strep (GBS) test yields results in an hour and works via a “simple” procedure that includes heat treatment, amplification and detection, according to a statement from Meridian.

GBS is a bacterial infection that can be passed to a woman’s baby during delivery. The bacteria is normally found in the vagina and/or rectum of about 25 percent of all healthy adult women, the American Pregnancy Association said.

The U.S. Centers for Disease Control and Prevention has recommended routine screening for GBS for all pregnant women to be performed between the 35th and 37th weeks of pregnancy.

Meridian is planning to release several other new tests on the illumigene platform over the next year or so.

 

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