) Xpert CT/NG test has been recently categorized as 'Moderate
Complexity' under the Clinical Laboratory Improvement Amendments
(CLIA) by the U.S. Food and Drug Administration (FDA). Earlier,
in December 2012, the company gained FDA clearance to market its
Xpert CT/NG test.
About Xpert CT/NG
Cepheid's Xpert CT/NG is an innovative qualitative in-vitro
molecular diagnostic test, based on the GeneXpert Systems, for
the detection and differentiation of
(NG). The test ensures same-day patient consultation and possible
treatment for two of the most common sexually transmitted
bacterial infections in the U.S.
Thus far, Cepheid's latest offering is the only molecular test
for CT/NG to be categorized as Moderately Complex. The
categorization will extend the testing universe which benefits
from molecular diagnostics.
The categorization is a milestone towards improvement of sexual
health and prevention of sexually transmitted diseases in the
U.S. With accessibility to over 20,000 Moderately Complex U.S.
labs and 7,000 High Complexity U.S. labs, Xpert CT/NG should lead
to lower rates of sexually transmitted disease going forward.
Chlamydia is the most common sexually transmitted bacterial
infection in the U.S. Despite widespread prevalence, the market
for chlamydia testing remains largely untapped. In 2011, the
disease infected more than a million Americans. According to
guidelines by the Centre for Disease Control and Prevention
(CDC), women aged 25 and under should undergo annual testing for
chlamydia. However, statistics suggest that only 38% of sexually
active women were tested in 2011.
Gonorrhea is the second most commonly reported bacterial
infectious disease in the U.S. Per CDC estimates, more than
700,000 individuals in the U.S. are infected with gonorrhea
annually. However, more than 50% of these cases remain
undiagnosed. While reported cases of gonorrhea decreased during
2007-2011, the figures for chlamydial infections remain
Based on a recent study by the Institute of Medicine and the
National Research Council, the highest rate of sexually
transmitted diseases in youths was recorded in the U.S. when
compared with 23 other developed nations. The quick diagnosis and
treatment of CT/NG and other sexually transmitted diseases will
help in controlling the epidemic of such diseases in the
We currently have a long-term Neutral recommendation on the
stock which carries a Zacks Rank #3 (Hold). We believe that
Cepheid's growth prospects are very attractive as the molecular
diagnostic franchise is the fastest growing segment in the
in-vitro diagnostics market.
The company has been consistently working on expanding its
portfolio of tests. We are encouraged by Cepheid's pipeline
development as it targets commercialization of 37 tests in the
U.S. and 36 tests in the offshore market by the end of 2017.
However, the company should take note of portfolio expansion
of other players in the industry. Its peers
Becton Dickinson and Company
) carry a Zacks Rank #2 (Buy).
BECTON DICKINSO (BDX): Free Stock Analysis
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