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Hologic's tests to detect vaginal infections win US FDA nod

The U.S. Food and Drug Administration approved Hologic Inc. Aptima BV and Aptima CV/TV tests to detect infections of the vagina.

Vaginitis generally refers to vaginal disorders caused by infection, inflammation or changes in the normal vaginal flora.

The tests can be used to detect vaginitis caused by bacterial vaginosis, vulvovaginal candidiasis — commonly known as a vaginal yeast infection — and trichomonas vaginalis infections. About 90% of vaginitis is caused by these types of infections in women.

Bacterial vaginosis is a type of vaginal inflammation caused by the overgrowth of bacteria naturally found in the vagina, which upsets the natural balance, while trichomoniasis a sexually transmitted disease caused by the single-celled protozoan parasite.

"The improved sensitivity and specificity of Hologic's molecular assays over traditional methods in determining the underlying cause of vaginitis not only means identifying the right infection, but enabling the right treatment and, in turn, reducing the potential for recurrent or persistent infections," said Edward Evantash, medical director and vice president of medical affairs at Hologic.

Hologic's Aptima multitest swab specimen kit help healthcare providers to test up to seven disease states and infections, including bacterial vaginosis, Candida species, Candida glabrata, trichomoniasis, chlamydia, gonorrhea and Mycoplasma genitalium.