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.
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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.