Devices & Diagnostics

Meridian Bioscience gets Australian OK for molecular group B strep test

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

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

The test is part of Cincinnati-area Meridian’s illumigene line of molecular diagnostic tests. 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 received U.S. Food and Drug Administration clearance of the test in December.

Group B strep 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.

“This test provides our customers with a simple platform for highly accurate detection of GBS infection, which can help prevent serious disease in infants,” said Colin Denver, regional sales director of Bioline Australia, a subsidiary of Meridian.

Meridian has said it plans to launch between three and four new tests per year from the illumigene product line. A test for Mycoplasma pneumonia, an infection of the lungs, is in clinical trials.

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