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

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

- Cepheid today announced that Health Canada has issued Cepheid a medical device license for Xpert ® Xpress SARS-CoV-2FluRSV 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 https://www.cepheid.com

*Cepheid internal study based on 30 minute test results.

For Cepheid Media Inquiries:
Darwa Peterson

SOURCE Cepheid

Cision View original content to download multimedia: https://www.newswire.ca/en/releases/archive/January2021/14/c6011.html

News Provided by Canada Newswire via QuoteMedia

The Conversation (0)
cardiologist wearing virtual reality glasses

2 Biggest Medical Device ETFs in 2024

Exchange-traded funds (ETFs) are a popular investment strategy, and generally contain a variety of publicly traded companies under one stock symbol, often with a focus on a specific sector.

Depending on the ETF, investors may be able to track up-and-coming companies, get exposure to top firms or a mix of both. Aside from stocks, some ETFs also track commodities or bonds.

In the healthcare industry, medical device ETFs bring together companies that go to great lengths to develop pharmaceutical-based technology that can improve the lives of patients.

Keep reading...Show less

Salix Announces 2024 Gastrointestinal Health Scholars Program

Salix to Provide Scholarships to 10 Students Living with GI Diseases

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) today announced the opening of the 2024 Salix Gastrointestinal Health Scholars Program application period. The program will award 10 exceptional students living with GI disease a scholarship of up to $10,000 as they work to pursue their higher education goals

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
Cleo Diagnostics

Cleo Completes Design Transfer

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to confirm that it has concluded design transfer activities relating to the core technology for its ovarian cancer detection test.

Keep reading...Show less

Grounding in Healing To Navigate the DEI Landscape in 2024


Dr. Sally Saba, Medtronic Chief Inclusion and Diversity Officer and Medtronic Foundation President

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Medtronic: Green Flags To Look For in ID&E Reporting

When it comes to inclusion, diversity, and equity reporting - not all reports are created equal

Following the pandemic and social unrest of 2020, many organizations prioritized inclusion, diversity, and equity (ID&E) to foster a more inclusive and equitable workplace, address systemic inequities, and promote a sense of belonging among their diverse workforces. But what actually drives impact

News Provided by ACCESSWIRE IA via QuoteMedia

Keep reading...Show less

Knight Therapeutics Announces Launch of Bijuva® in Canada

Knight Therapeutics Inc., (TSX: GUD) ("Knight"), a Pan-American (ex-USA) specialty pharmaceutical company, announced today the launch of BIJUVA ® (estradiol and progesterone) capsules in Canada. BIJUVA ® is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause in women with an intact uterus. VMS affects 60% to 80% of women entering menopause 1 and are commonly known as hot flashes or flushes and night sweats. BIJUVA ® is a once-daily combination of bioidentical estradiol and progesterone in a single oral capsule. The two hormones included in BIJUVA ® have the same structure as the hormones produced and circulating in a woman's body.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News