Thursday, June 29, 2017

Molecular test for common causes of vaginitis receives FDA approval

molecular test for vaginitis, vaginitis gynecology news
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"Johns Hopkins researchers report that a molecular diagnostic test accurately distinguishes among the three most common causes of vaginitis, an inflammation of vaginal tissue they say accounts for millions of visits to medical clinics and offices in the U.S. each year.

In an article published June 8 in Obstetrics & Gynecology, the investigators said the new assay -- based on the presence of the genetic footprints of bacteria, yeast and the sexually transmitted protozoa trichomonas -- was as accurate as and more objective than traditional laboratory tests.

"Overall, the disease prevalence identified by the traditional and the new molecular methods were similar," according to Charlotte Gaydos, Dr.P.H., M.P.H., professor of medicine and director of the Johns Hopkins Center for the Development of Point of Care Tests for Sexually Transmitted Diseases at the Johns Hopkins University School of Medicine.

The comparative data, she added, earned U.S. Food and Drug Administration market authorization for use by diagnostic laboratories on October 28, 2016. The assay is licensed to BD Diagnostics, which will market it under the BD MAX™ Vaginal Panel..."

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