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FDA Clears Two Hologic Vaginitis Assays

NEW YORK (GenomeWeb) – Hologic announced today that the US Food and Drug Administration has cleared two of its infectious disease assays for common causes of a condition called vaginitis. The first is a test for bacterial vaginosis, while the second is an assay that detects and differentiates common causes of yeast infections from parasitic trichomonas infections.

The Hologic Aptima BV and Aptima CV/TV assays run on the firm's Panther and Panther Fusion systems, Together, they detect approximately 90 percent of the causes of vaginitis cases that affect millions of women annually. The symptoms of these three causes of vaginitis are similar, so they are often misdiagnosed, leading to improper treatment and recurring infection.

"Vaginitis is one of the most common reasons women visit a healthcare provider, and Hologic's new molecular assays have the potential to transform how these infections are diagnosed in that very first appointment," said Edward Evantash, medical director and vice president of medical affairs at Hologic, in a statement.

"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," Evantash added.

Candida vaginitis, commonly known as a yeast infection, is frequently self-diagnosed and treated with over-the-counter medication. However, a simple yeast infection is not always the correct diagnosis because the symptoms of vulvovaginal candidiasis are similar to other infections, co-infections are common, and more rare species of candida can cause more virulent infection.

The Aptima CV/TV test differentiates candida from trichomonas infection, but also differentiates between yeast infections caused by Candida albicans and Candida glabrata. The former is most prevalent, while the latter can be more difficult to treat, and sometimes requires more aggressive therapies, the firm said.

Hologic also noted that the CDC recommends testing for trichomonas in all women seeking treatment for vaginal discharge and specifically recommends the use of nucleic acid amplification tests.

Bacterial vaginosis, meanwhile, is the most common vaginal infection in the US, affecting an estimated 21 million women ages 14 to 49 years old, Hologic said.

The risks associated with untreated, persistent bacterial vaginosis or Trichomonas vaginalis infection include an increased likelihood of contracting a sexually transmitted infection upon exposure, as well as pelvic inflammatory disease, infertility, and pregnancy complications such as premature delivery and low birth weight.

These two FDA clearances bring the total number of Hologic Panther system assays cleared in the US to 16 for the detection of more than 20 pathogens. The firm claims it now offers "the only high-throughput molecular diagnostic platforms in the US to combine comprehensive sexual health, cervical health, viral load, respiratory testing, and open channel functionality on a fully automated system."

In Wednesday morning trade on the Nasdaq, shares of Hologic were down 1 percent at $43.67.

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