SUNNYVALE, Calif., Oct. 27, 2016 /PRNewswire/ -- With the flu
season fast approaching, healthcare providers no longer need to
choose between a fast test result or an accurate test result for
patients suspected of influenza infection. Now, they can have
both, with Xpert® Xpress Flu/RSV from Cepheid (Nasdaq: CPHD), a new
test that delivers reference-quality molecular test results in as
little as twenty minutes.1
"For too long, clinicians have been asked to treat suspected
cases of influenza empirically, since gold-standard RT-PCR based
tests took too long to process in the critical first 24 hours of
symptom onset," said David H.
Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology
Officer. "With the arrival of fast molecular tests like Xpert
Xpress Flu/RSV, patients and their healthcare providers can now
expect an accurate diagnosis, and access to targeted therapies
substantially more quickly. Unnecessary treatment with
antimicrobial agents can also be avoided. This supports
clinical efforts to improve the patient experience, and further
streamlines workflow in the laboratory, which can be particularly
challenging in the midst of a busy respiratory virus season."
Upper respiratory infections are among the most common reasons
for outpatient visits in the United
States and worldwide.2,3 Early
symptoms for a wide variety of viral and bacterial respiratory
infections are often clinically indistinguishable, yet treatment is
different depending on the cause of infection, highlighting the
importance of accurate diagnostic tests like Xpert Xpress
Flu/RSV. With this development, hospitals and clinics can
reliably diagnose influenza and respiratory syncytial virus (RSV)
infection in 30 minutes or less.
Xpert Xpress Flu/RSV is twice as fast as its predecessor, Xpert
Flu/RSV XC, but has comparable performance characteristics.
The new assay features a novel design, which employs multiple
targets for each virus. The built-in redundancy provides very
high test sensitivity, avoiding the impact of seasonal drift that
has been a problem historically with molecular tests, while
maintaining high specificity. This assay is the first in a series
of tests from Cepheid that will deliver results in 30 minutes or
less.1
The new test is available immediately in the EU and all
countries recognizing the CE-Mark.
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
24 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
and clinical efficacy of the Xpert Xpress Flu/RSV test, the test's
impact on speed of access to targeted therapy, improving patient
experience and streamlining the workflow in the lab, and the launch
of future Cepheid tests targeting results in 30 minutes or
less. 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;
the Company's ability to successfully and timely develop new
products, particularly those targeting results in 30 minutes or
less; 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 Results from negative specimens are reported in
approximately 30 minutes. When running in a Flu only or an
RSV only reporting mode, positive results can be reported in soon
as 20 minutes.
2 "Upper Respiratory Tract Infection" Medscape.
Menegetti et al; June 2016
(http://emedicine.medscape.com/article/302460-overview)
3
http://www.cdc.gov/rsv/research/us-surveillance.html
For Cepheid Media & Investor Inquiries:
Jacquie Ross, CFA
+1 408-400-8329
corporate.communications@cepheid.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/30-minute-or-less-molecular-flursv-test-now-available-outside-the-us-300348933.html
SOURCE Cepheid