Gen-Probe Trichomonas Test Cleared - Analyst Blog
April 21 2011 - 1:18PM
Zacks
Diagnostic products maker
Gen-Probe Inc (GPRO) has won the approval of the
U.S. Food and Drug Administration (“FDA”) for its APTIMA assay for
Trichomonas vaginalis, a sexually transmitted disease. The
California-based company filed the 510 (k) application for the
assay with the regulator in October 2010. The APTIMA
Trichomonas assay was cleared in Europe in June
2010.
Trichomonas, a sexually
transmitted parasite, can cause inflammatory conditions such as
vaginitis and urethritis and can make women susceptible to the HIV
infection. According to the U.S. Centers for Disease Control,
Trichomonas infection afflicts roughly 7.4 million people
annually in North America, making it more prevalent than chlamydia
and gonorrhea, the most common sexually transmitted bacterial
infections.
Currently, screening for
Trichomonas is limited, in part, due to the shortcomings
of the existing testing methods such as culture and wet mount
microscopy (microscopic examination of a sample). These traditional
techniques are slow and less sensitive vis-à-vis molecular
tests.
The APTIMA Trichomonas
assay leverages the same nucleic acid amplification technologies as
Gen-Probe’s market leading chlamydia and gonorrhea test APTIMA
COMBO 2 assay. It is the first approved amplified nucleic acid test
(“NAT”) to specifically detect Trichomonas vaginalis.
Based on the clinical study results, Gen-Probe’s amplification
technology offers greater sensitivity than the current test
techniques.
Moreover, the APTIMA
Trichomonas assay can be used with Gen-Probe’s TIGRIS
system, the only fully automated testing system for molecular
diagnostics, to test the same samples used with APTIMA COMBO 2.
This will offer a convenient way for physicians and laboratories to
provide fast and accurate detection of infectious diseases.
Gen-Probe is a dominant player in
the rapidly expanding NAT market, the fastest growing segment of
the clinical diagnostic market. It is a market leader in
domestic gonorrhea and chlamydia testing with its PACE and APTIMA
assay product lines. Gen-Probe competes with more established firms
in the molecular diagnostic industry such as Roche
(RHHBY), Becton Dickinson (BDX), and
Abbott Labs (ABT).
Gen-Probe has a strong pipeline of
novel assay products that are expected to drive future
growth. Moreover, the ongoing market shift away from traditional
diagnostic methods towards molecular testing represents a tailwind
for the company. Currently, we have a Neutral recommendation on
Gen-Probe.
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