NEW YORK (GenomeWeb News) – Meridian Bioscience today announced the US Food and Drug Administration has cleared its molecular diagnostic test for Group B Streptocococcus (GBS).
The clearance is the second for a Meridian MDx test that runs on its illumigene platform, following FDA clearance of the Cincinnati-based firm's test for C.difficile in June 2010.
According to the company, Strep B is a major perinatal pathogen for both mothers and infants, and the GBS test allows laboratories to comply with recommendations from the Centers for Disease Control and Prevention calling for universal culture-based screening to be performed at 35 to 37 weeks of gestation.
The test, Meridian said, has a simplified workflow and increased sensitivity "for early diagnosis and proper management." Using loop-mediated isothermal DNA amplification technology, the GBS test can yield results in less than one hour.
"The new test begins the expansion of the illumigene platform and provides a molecular technology that is affordable, simple, and quick," Richard Eberly, COO of Meridian, said in a statement.
In its fourth-quarter earnings release last month the company said that it plans launches later this year of its illumigene Mycoplasma pneumonia, illumigene Group A Strep, and illumigene Pertussis for whooping cough tests.