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ClearPath launches molecular assay for Group B Strep

SYRACUSE — ClearPath Diagnostics has launched a new women’s health molecular assay for the detection of Group B Streptococcus (GBS) from Meridian Bioscience, Inc. The new assay, named illumigene GBS, is the next generation of technology for GBS testing, ClearPath says. Sensitivity on the new assay approaches 99 percent versus a range of 65 percent […]

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With more than 4.3 million births in the U.S., GBS is the leading cause of morbidity and mortality in infants, with the most common complication being early-onset neonatal sepsis. Infant mortality is preventable with appropriate diagnostic testing, according to ClearPath Diagnostics.

“The illumigene test will ultimately help us prevent infant mortality for patients who might otherwise not be accurately diagnosed,” Michael A. Jozefczyk, M.D., president of ClearPath Diagnostics, said in a news release.

GBS testing is recommended by the Centers for Disease Control (CDC) for use in all pregnant women in their third trimester.

Journal Staff