SUNNYVALE, Calif., June 9, 2020 /PRNewswire/ -- Cepheid today
announced the development of a next-generation test to assist
global efforts in the fight against the spread of COVID-19 during
the upcoming respiratory virus season. The Xpert® Xpress
SARS-CoV-2/Flu/RSV four-in-one test is expected to deliver
qualitative detection of SARS-CoV-2, Flu A, Flu B and RSV from a
single patient sample. The test is designed for use on any
of Cepheid's more than 25,000
GeneXpert® Systems placed worldwide, with results
expected in as little as 35 minutes.
"Patients infected by SARS-CoV-2, Flu A, Flu B, and RSV have
overlapping clinical presentations, but fundamentally different
treatment and management pathways," said Dr. David Persing,
MD, Ph.D., Chief Medical and Technology Officer at
Cepheid. "Unlike the common cold viruses, infection with these
four viruses is often associated with fever and other systemic
manifestations that may be coupled with severe outcomes, especially
in the elderly."
In the coming weeks, Cepheid intends to pursue the FDA's
Emergency Use Authorization (EUA) pathway for regulatory
authorization and make the test available globally on its
cartridge-based GeneXpert Systems, which features instruments that
can be configured for both near patient point-of-care and high
volume laboratory testing needs.
"On March 20th, Cepheid was
granted the first-ever EUA by the FDA for use in point-of-care
settings for our Xpert Xpress SARS-CoV-2 test," said Cepheid
President Warren Kocmond. "Since
then, we have experienced unprecedented demand for this technology.
Leveraging the quality design of Xpert Xpress SARS-CoV-2 and our
widely utilized Xpert Xpress Flu/RSV tests, we're combining two
world-class products in a single, rapid solution ahead of the
upcoming flu season. This will enable our customers to have
increased testing throughput on their current GeneXpert System
and increase our ability to provide supply continuity for the
market."
Visit www.cepheid.com/coronavirus for latest updates on our
SARS-CoV-2 tests.
GeneXpert's Modular Design Enables High-Volume Laboratory and
Near-Patient Point-of-Care Testing
The GeneXpert System was built for simple, reference lab quality
PCR testing – on location at medical centers and hospitals or
closer to patient in health clinics and nursing homes. At the core
of every GeneXpert System is the module (or testing bay) where a
test cartridge is loaded onto the machine. Our line of GeneXpert
Systems can be configured with a varying number of modules, or test
bays, to meet the volume requirements of any setting. Smaller
GeneXpert Systems are configured with 2 or 4 modules – meaning up
to four different tests can be run at one time. Our largest
GeneXpert System is configured with up to 80 modules – meaning as
many as 80 tests can operate independently at any given time with a
capacity of about 2,000 tests per day*.
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 molecular diagnostic 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.
*Cepheid internal study based on 30 minute test
results.
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