SUNNYVALE, Calif., Sept. 29, 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/Flu/RSV, a rapid molecular diagnostic
test for qualitative detection of the viruses causing COVID-19, Flu
A, Flu B, and RSV infections from a single patient sample. The
four-in-one test is designed for use on any
of Cepheid's over 26,000
GeneXpert® Systems placed worldwide, with results
delivered in approximately 36 minutes.
"Things may get complicated this respiratory season as
clinicians encounter a range of viral infections with symptoms
overlapping with COVID-19, including Flu A, Flu B, and respiratory
syncytial virus," said Dr. David Persing, MD, Ph.D., Chief
Medical and Technology Officer at Cepheid. "The ability to run
a single, highly sensitive test that detects all four viruses in a
syndromic panel provides actionable results and helps to alleviate
pressure on our healthcare system."
Cepheid's previously announced capacity expansion program,
supported by parent company Danaher Corporation, was designed in
part to address anticipated demand for
Xpert Xpress SARS-CoV-2/Flu/RSV. Cepheid
expects the first impact of the program in the fourth quarter of
2020 with additional capacity ramping through 2021.
"The dramatic impact of SARS-CoV-2 has been felt by us all, and
we understand that a reliable supply of SARS-CoV-2 tests is
critical to the communities our healthcare institutions serve — for
the coming Flu season and beyond," said Cepheid President
Warren Kocmond. "Another goal of the
capacity expansion program is to ensure supply continuity of not
only our 4-Plex combination test for SARS-CoV-2, Flu A&B and
RSV, but the entire portfolio of critical tests Cepheid supplies —
including tests for tuberculosis, MRSA, C. difficile, CT/NG,
Strep A, and many more."
The new EUA combination test is expected to begin shipping to US
customers this week, with expected CE-IVD availability in
November.
Visit www.cepheid.com/coronavirus for more information, videos,
package inserts and more.
GeneXpert System – Reference Lab Quality Tests Anywhere They
Are Needed
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 GeneXpert Systems
are 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.
About Emergency Use Authorization Status
This test has
not been FDA cleared or approved. It has been authorized by the FDA
under an EUA for use by authorized laboratories. The test has been
authorized only for the simultaneous qualitative detection and
differentiation of nucleic acid from SARS-CoV-2, influenza A virus,
influenza B virus, and RSV and not for any other viruses or
pathogens. The test is only authorized for the duration of the
declaration that circumstances exist justifying the authorization
of emergency use of in vitro diagnostic tests for detection and/or
diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C.
§ 360bbb-3(b)(1), unless the authorization is terminated or revoked
sooner.
*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