SUNNYVALE, Calif., March 21, 2020 /PRNewswire/ -- Cepheid today
announced it has received Emergency Use Authorization (EUA) from
the U.S. Food & Drug Administration (FDA) for Xpert®
Xpress SARS-CoV-2, a rapid molecular diagnostic test
for qualitative detection of SARS-CoV-2, the virus causing
COVID-19. The test has been designed to operate on any of Cepheid's
more than 23,000 automated GeneXpert® Systems
worldwide, with a detection time of approximately 45 minutes.
"During this time of increased demand for hospital services,
Clinicians urgently need an on-demand diagnostic test for real-time
management of patients being evaluated for admission to health-care
facilities. An accurate test delivered close to the patient can be
transformative — and help alleviate the pressure that the emergence
of the 2019-nCoV outbreak has put on healthcare facilities that
need to properly allocate their respiratory isolation resources,"
said Dr. David Persing, MD, Ph.D., Chief Medical and
Technology Officer at Cepheid. "By leveraging the design principles
of our current Xpert Xpress Flu/RSV cartridge
technology, in which multiple regions of the viral genome are
targeted to provide rapid detection of current and potential
future variants of SARS-CoV-2, we have developed a test that
provides reference lab-quality results in multiple settings where
actionable treatment information is needed quickly."
"Cepheid currently has nearly 5,000 GeneXpert®
Systems in the US capable of point-of-care testing and for use in
hospitals," said Cepheid President Warren
Kocmond. "Our automated systems do not require users to have
specialty training to perform testing — they are capable of running
24/7, with many systems already doing so today."
The test will begin shipping next week. For more information
about Cepheid's Xpert Xpress SARS-CoV-2 test, please visit
www.cepheid.com/coronavirus.
About Cepheid
Based in Sunnyvale, Calif.,
Cepheid is a leading molecular diagnostics company that is an
operating company within Danaher Corporation's (NYSE: DHR)
Diagnostics platform. Cepheid 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 http://www.cepheid.com.
For Cepheid Media Inquiries:
Darwa Peterson
darwa.peterson@cepheid.com
Media Contacts:
Jason
Spark,
CanaleComm, jason@canalecomm.com
Cammy Duong,
CanaleComm, cammy@canalecomm.com
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SOURCE Cepheid