SUNNYVALE, Calif., Sept. 6, 2016 /PRNewswire/ -- Men in the United States can now have easier access
to fast and accurate testing for a potentially dangerous sexually
transmitted infection, thanks to expanded claims allowed by the
Food and Drug Administration (FDA) for the Xpert TV assay by
Cepheid (Nasdaq: CPHD), a sensitive urine-based test for
Trichomonas vaginalis that delivers results in as little as
35 minutes.
Trichomoniasis ("Trich") is considered to be the most common
non-viral sexually transmitted infection in the United States, infecting an estimated 1.4
million men.1 Trich is particularly
challenging because as many as 85% of infected individuals have
minimal to no symptoms, allowing for potentially silent spread of
the infection.2
"A decade ago, Trichomonas vaginalis infections in men
were virtually ignored, but recent research has associated these
infections with urethritis, prostate inflammation and possibly male
infertility3," said David
Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology
Officer. "Further, there is strong evidence that
suggests Trich acts as a co-factor in sexual transmission of
HIV4, highlighting the importance of easily accessible
diagnostics for all patients, regardless of gender."
Following initial clearance of Xpert TV for three types of
female specimens in October of 2015, the latest clearance extends
the range of potential uses of the assay, and positions Xpert TV as
the only cleared Nucleic Acid Amplification Testing (NAAT) test for
urine samples from symptomatic and asymptomatic men.
Xpert TV extends the reach of Cepheid's portfolio of 20 Xpert
tests in the United States for the
GeneXpert System, the world's leading molecular diagnostic platform
with more than 11,000 systems installed globally. Xpert TV
with the extended claim is expected to begin shipping later this
month.
About Cepheid
Based in Sunnyvale, Calif.,
Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company
that is dedicated to improving healthcare by developing,
manufacturing, and marketing accurate yet easy-to-use molecular
systems and tests. By automating highly complex and time-consuming
manual procedures, the company's solutions deliver a better way for
institutions of any size to perform sophisticated genetic testing
for organisms and genetic-based diseases. Through its strong
molecular biology capabilities, the company is focusing on those
applications where accurate, rapid, and actionable test results are
needed most, such as managing infectious diseases and cancer. For
more information, visit www.cepheid.com.
About GeneXpert Systems and Xpert Tests
With more than 11,000 systems in 182 countries, the GeneXpert
System is the world's most popular molecular diagnostics'
system. The GeneXpert System's modular configuration means
that the system is the most scalable available, offering the
ability to perform from one to eighty Xpert tests at the same
time. As a result, the GeneXpert System meets the throughput
requirements of customers of all sizes - from lower volume
point-of-care settings to higher volume reference laboratories –
enabling accurate, fast and cost effective test results.
GeneXpert Systems run proprietary Xpert test cartridges.
The Xpert test menu spans healthcare-associated infections, sexual
health, critical infectious disease, and oncology, and today offers
23 tests outside the US, and 20 tests in the US. More
information on the GeneXpert System and the Xpert tests is
available on our website at www.cepheid.com.
Forward Looking Statements
This press release contains forward-looking statements that are
not purely historical regarding Cepheid's or its management's
intentions, beliefs, expectations and strategies for the future,
including those relating performance, technical and product
specifications, sensitivity, speed, accuracy, diagnostic utility,
accessibility, and clinical efficacy of the GeneXpert TV Assay in
testing for Trichomoniasis in symptomatic and asymptomatic men and
the timing of initial shipments of the test for such purpose.
Because such statements deal with future events, they are subject
to various risks and uncertainties, and actual results could differ
materially from Cepheid's current expectations. Factors that could
cause actual results to differ materially include risks and
uncertainties such as those relating to: test performance in the
field; utilization of the Company's tests by clinicians and future
changes in medical practice and protocols; delays in the initial
shipment of the GeneXpert TV Assay for expanded male urine claims;
the Company's ability to successfully and timely develop new
products; the completion of clinical trials for new products
successfully and in a timely manner; uncertainties related to the
United States FDA, European and other regulatory processes; the
Company's ability to successfully introduce and sell products in
global markets; the Company's research and development budget;
unforeseen supply, development and manufacturing problems; the
potential need for additional intellectual property licenses for
tests and other products and the terms of such licenses; the impact
of competitive products and pricing; the costs of product
components and other factors affecting product pricing; the
Company's ability to manage geographically-dispersed operations;
and underlying regulatory, political and market conditions
worldwide. Readers should also refer to the section entitled "Risk
Factors" in Cepheid's Annual Report on Form 10-K, its most recent
Quarterly Report on Form 10-Q, and its other reports filed with the
Securities and Exchange Commission.
All forward-looking statements and reasons why results might
differ included in this release are made as of the date of this
press release, based on information currently available to Cepheid,
and Cepheid assumes no obligation to update any such
forward-looking statement or reasons why results might differ.
1 Am J Trop Med Hyg. 2014 May
7; 90(5): 800–804.
2 http://www.cdc.gov/std/tg2015/trichomoniasis.htm
3 A Review of Evidence-Based Care of Symptomatic
Trichomoniasis and Asymptomatic vaginalis Infections. Meites et al,
Critical Infectious Disease, 2015
4 Sex Transm Infect. 2013 September ; 89(6): 426-433.
Doi: 10.1136/sextrans-2012-051005
For Cepheid Media & Investor Inquiries:
Jacquie Ross, CFA
+1 408-400-8329
corporate.communications@cepheid.com
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SOURCE Cepheid