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Recently, Hologic Inc. (HOLX - Analyst Report), a prominent player in the women’s healthcare market, gained the U.S. Food and Drug Administration (FDA) clearance for the commercial launch of its Aptima Trichomonas vaginalis Assay to be used on its fully-automated Panther System. The clearance has expanded the company’s diagnostic portfolio.

The Aptima Trichomonas vaginalis Assay is the only FDA-cleared amplified nucleic acid test to detect Trichomonas vaginalis, the most prevalent curable sexually transmitted infection reported in the U.S. Earlier, following the FDA clearance in April 2011, the Aptima Trichomonas vaginalis Assay was used only on Hologic’s Tigris System.  

Potential Market

Trichomonas is a commonly reported sexually transmitted infection caused by a parasite. According to statistics from the U.S. Centre for Disease Control and Prevention, an estimated 7.4 million Americans suffer from Trichomonas annually. However, about 70% of the infected individuals do not exhibit any symptoms.

Although Trichomonas is the most common curable sexually transmitted disease, it can cause severe health-related problems if it remains undiagnosed. It can lead to infertility in women, pelvic inflammatory disease, premature births with lower-than-normal birth weight and higher risk of HIV transmission.

The nucleic acid testing has many advantages over the tests currently available in the market. The widely used culture method is slow and less sensitive compared with the molecular assay testing used by Hologic.

Considering that women in the U.S. are more prone to this infection, which is exacerbated by low testing rates, the commercialization of Hologic’s Aptima Trichomonas vaginalis Assay presents an opportunity to improve reproductive health in the U.S.

Our Take

The test menu expansion on Hologic’s Panther System should catalyze growth going forward. It is also likely to extend the test menu available at hospital laboratories, one of the fastest growing divisions of the healthcare industry.

The Aptima assays along with the molecular diagnostic platforms of Panther and Tigris Systems were inducted in Hologic’s portfolio with the acquisition of Gen-Probe (completed in August 2012). The company currently derives 44% of its revenues from the diagnostics franchise. This is likely to increase in the future as Hologic continues to expand its test menu.

We currently have a long-term Neutral recommendation on the stock, which carries a Zacks Rank #3 (Hold). One of its peers, QIAGEN NV (QGEN - Analyst Report), carries a Zacks Rank #2 (Buy).

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