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Cepheid Receives Health Canada License for SARS-CoV-2, Flu A, Flu B and RSV Combination Test

·3 min read

Challenged by Similar Clinical Presentations, Accurate Detection & Differentiation of all 4 Viruses is Critical for Clinicians This Flu Season

SUNNYVALE, Calif., Jan. 14, 2021 /PRNewswire/ -- Cepheid today announced that Health Canada has issued Cepheid a medical device license 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 test is now available in Canada and can be used in laboratories and at the point of care. The four-in-one test is designed for use on any of Cepheid's almost 30,000 GeneXpert® Systems placed worldwide, with results delivered in approximately 36 minutes.

"The ability to run a single, highly-sensitive test that detects SARS-CoV-2, Flu A, Flu B, and respiratory syncytial virus provides actionable results and helps to alleviate pressure on the healthcare system," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "Xpert® Xpress SARS-CoV-2/Flu/RSV delivers reference lab quality testing in a cartridge that can be run near-patient, often providing results while patients are being seen or admitted. Rapid results help healthcare workers make real-time patient management decisions including qualification for antiviral therapy and triage for emergency procedures."

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.

"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."

Visit www.cepheid.com/en/about/SARS-CoV-2-Test-Development-Information 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

*Cepheid internal study based on 30 minute test results.

For Cepheid Media Inquiries:
Darwa Peterson
darwa.peterson@cepheid.com

SOURCE Cepheid