Medical Device

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 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

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

News Provided by Canada Newswire via QuoteMedia

Johnson & Johnson to Participate in the Cowen 43rd Annual HealthCare Conference

Johnson & Johnson (NYSE: JNJ) will participate in the Cowen 43 rd Annual HealthCare Conference on Tuesday, March 7 th , at the Boston Marriott Copley Place, Boston, MA. Joseph J. Wolk, Executive Vice President and Chief Financial Officer will represent the Company in a session scheduled at 11:10 a.m. (Eastern Time).

This live audio webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com .

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Thermo Fisher Scientific to Power All Current U.S. Sites With 100 Percent Renewable Electricity

Thermo Fisher's latest net-zero milestone to be achieved through 200-megawatt solar project

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced it will power all of the company's current U.S. sites with 100 percent renewable electricity by 2026. The company's new 20-year virtual power purchasing agreement with EDF Renewables includes the full output of the 200-megawatt (MW) Millers Branch Solar project.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Medtronic continues to make significant advances as an Inclusion, Diversity & Equity leader

Medtronic named to the 2023 Bloomberg Gender-Equality Index (GEI) the same week the company publishes its Global Inclusion, Diversity & Equity 2022 Annual Report

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, announced that it joins 483 other global companies as a member of the 2023 Bloomberg Gender-Equality Index (GEI) a modified market capitalization-weighted index developed to gauge the performance of public companies dedicated to reporting gender-related data.

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less

Bausch Health to Announce Fourth-Quarter and Full-Year 2022 Results on Feb. 23

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) will release its fourth-quarter and full-year financial results on Thursday, Feb. 23, 2022. Bausch Health will host a conference call and live webcast at 8:00 a.m. U.S. EST to discuss the results and provide a business update. All materials will be made available on the Investor Relations section of the Bausch Health website prior to the start of the call

Conference Call Details

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less

Thermo Fisher Scientific Reports Fourth Quarter and Full Year 2022 Results

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the fourth quarter and full year ended December 31, 2022.

Fourth Quarter and Full Year 2022 Highlights

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Federal Appellate Court Rejects Controversial J&J Ploy to Dodge Talc Cancer Lawsuits

Nachawati Law Group: Ovarian cancer victims deserve day in court

Trial lawyers with the Nachawati Law Group praised a ruling by the U.S. Court of Appeals for the Third Circuit rejecting Johnson & Johnson's (NYSE: JNJ) use of a controversial bankruptcy ploy to shed more than 38,000 lawsuits filed by women who developed ovarian cancer after using J&J's talc-based products.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×