ClearPath Diagnostics Launches Molecular Assay for Group B Streptococcus, Improves Third Trimester Strep B Accuracy on Pregnant Women by Up to 50%

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ClearPath Diagnostics has launched a new women’s health molecular assay, illumigene® GBS from Meridian Bioscience, Inc., that detects Group B Streptococcus (GBS). Sensitivity on the new assay approaches 99% versus a range of 65% with the culture method.

"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

ClearPath Diagnostics, a leading anatomical pathology lab serving upstate New York, with expansion plans underway throughout the Northeast, 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, replacing the current culture methodology used in most US laboratories today. Sensitivity on the new assay approaches 99% versus a range of 65% with the culture method.

With over 4.3 million births in the US, 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.

ClearPath Diagnostics provides anatomic pathology and women’s health diagnostics to over 60% of the OB/GYN physician offices in its currently served markets. It has selected the Meridian Bioscience illumigene GBS test not only for its excellent sensitivity, specificity, ease of use, and FDA compliance, but because the test is available nationwide to support the labs expansion plans.

Michael A. Jozefczyk, M.D., president of ClearPath Diagnostics commented, “We are excited to begin offering our clients the new Meridian Group B Strep test. This test is another example of our commitment to excellence in launching innovative assays in which clinicians are provided more accurate information to diagnose and treat challenging health issues facing women every day. The illumigene test will ultimately help us prevent infant mortality for patients who might otherwise not be accurately diagnosed.”

GBS testing is recommended by the Centers for Disease Control (CDC) for use in all pregnant women in their third trimester. The illumigene GBS test offers the best overall performance of any assay available on the market that is fully CDC compliant. Every test taken increases the likelihood of improved outcomes and a healthy mother and infant.

Jack Kraeutler, Meridian Bioscience, Inc. CEO said, “Simply stated…a successful pregnancy is one that results in a healthy baby being born. We are delighted that our illumigene GBS technology has been adopted by ClearPath Diagnostics as a primary element of its women’s health initiative. Accurate detection of Group B Streptococcal infection during pregnancy is a critical step leading to appropriate treatment of the expectant mother at the time of labor and delivery.”

For more information on test offering available at ClearPath Diagnostics, visit http://www.ClearPathDiagnostics.com.

For additional information on illumigene products and Meridian Bioscience; visit http://www.meridianbioscience.com.

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Stewart Koenig
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