), 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.
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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
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
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
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
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,
), carries a Zacks Rank #2 (Buy).