SUNNYVALE, Calif., Oct. 5, 2016 /PRNewswire/ -- There's now an
easier way to confidently rule out bladder cancer recurrence,
thanks to a new test from Cepheid (Nasdaq: CPHD), Xpert® Bladder
Cancer Monitor, now commercially available in Germany and cleared for commercial
availability in all countries accepting the CE Mark.
Bladder cancer is the 5th most common cancer in
Europe, affecting over 150,000
patients annually1,2 and is among the most expensive
cancers on a cost per treatment basis3, in part due to
high recurrence rates and invasive surveillance strategies,
including cystoscopy, that have traditionally been required to
manage the condition. Xpert Bladder Cancer Monitor is
designed to provide up-to-date information on cancer recurrence for
bladder cancer patients, using a noninvasive urine specimen.
The test has an overall 93.9% negative predictive value, providing
urologists with actionable results to more confidently risk manage
their patients, potentially reducing the need for as-frequent
invasive testing.
"Xpert Bladder Cancer Monitor delivers accurate results
noninvasively in just 90 minutes, which may improve compliance
in patients being monitored for bladder cancer recurrence,"
said David H. Persing, M.D., Ph.D., Cepheid's Chief
Medical and Technology Officer. "We believe the test will
also likely improve workflow management for urologists and their
bladder cancer patients because it provides same day, clinically
actionable results that inform important downstream management
decisions."
"Bladder cancer continues to have the highest lifetime treatment
costs per patient out of all of the cancers and - with a rising
population - those costs will continue to add up," said
Maximilian Burger of the Department
of Urology, University of Regensburg. "Bladder cancer
continuously demands treatment decisions that can impact outcomes
and quality of life. Guidance tools tailored to patient
management fill this unmet need."
Xpert Bladder Cancer Monitor features an overall sensitivity of
75%, sensitivity for high grade tumors, specifically, of 84%, and
an overall specificity of 80.6%. The new test is available
immediately in Germany, and will
launch throughout Europe in the
coming months.
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, specificity, speed, accuracy,
diagnostic utility and clinical efficacy of the Xpert Bladder
Cancer Monitor test, the timing of the test's commercial
availability, the test's ability to reduce costs of cancer
treatment for bladder cancer, and the test's ability to improve
hospital workflow in the treatment of bladder cancer patients and
to manage recurrence risks and reduce the need for, and frequency
of, invasive testing. 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 ability of hospitals to better allocate urology
resources and direct patient care based on information obtained
from the tests; delays in commercial launch of the tests throughout
Europe; 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 EUCAN Bladder Cancer Fact Sheet (published 2012).
Retrieved from http://eco.iarc.fr/eucan/Cancer.aspx?Cancer=32
2 Ferlay J, Steliarova-Foucher E, Lortet-Tieulent J,
Rosso S, Coebergh JWW, Comber H, Forman D, Bray F. Cancer incidence
and mortality patterns in Europe:
estimates for 40 countries in 2012. Eur J Cancer. 2013
Apr;49(6):1374-403. doi: 10.1016/j.ejca.2012.12.027.
3 Svatek, Robert S., et al. "The economics of bladder
cancer: costs and considerations of caring for this
disease." European urology 66.2 (2014):
253-262.
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/new-bladder-cancer-test-could-reduce-number-of-invasive-procedures-required-for-recurrence-monitoring-300339950.html
SOURCE Cepheid