Trending...
- Skool Alternatives Reddit: Skool vs Circle vs Whop - Did you join one yet?
- Cal State LA secures funding for two artificial intelligence projects from CSU
- AI Visibility: The Key to Beating Google's AI Overviews and Regaining Traffic
SUNNYVALE, Calif., Sept. 14, 2021 /PRNewswire/ -- Cepheid today announced it has received Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) for Xpert Xpress CoV-2/Flu/RSV plus, a rapid molecular diagnostic test for qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and respiratory syncytial virus (RSV) infections from a single patient sample. The new plus version of the test provides a third gene target for SARS-CoV-2 detection to meet the challenge of future viral mutations. Xpert Xpress CoV-2/Flu/RSV plus is designed for use on any of Cepheid's over 35,000 GeneXpert® Systems placed worldwide, with results delivered in approximately 36 minutes.
Multiple variants of the virus that causes COVID-19 have been documented globally during the pandemic. Viruses constantly change through mutation, and new variants of a virus are expected to occur over time. Adding a 3rd gene target to the plus version of Cepheid's CoV-2/Flu/RSV test delivers broader coverage to mitigate the possible effects of future viral genetic drift.
"This respiratory season, healthcare providers may encounter a range of viral infections with symptoms that overlap with COVID-19, including Flu A, Flu B, and respiratory syncytial virus. Having a fast and accurate test that is designed to detect current and future variants of the viruses that cause COVID-19 and influenza will become increasingly important," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "The ability to collect one sample and run a single, highly-sensitive multiplexed test that detects and differentiates all four viruses will provide actionable results to inform better front-line decisions within our healthcare systems."
More on The Californer
Xpert Xpress CoV-2/Flu/RSV plus is expected to begin shipping to US customers in the next few weeks.
Visit www.cepheid.com for more information, videos, and package inserts.
About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company. 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.
More on The Californer
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.
For Cepheid Media Inquiries:
Darwa Peterson
[email protected]
SOURCE Cepheid
Multiple variants of the virus that causes COVID-19 have been documented globally during the pandemic. Viruses constantly change through mutation, and new variants of a virus are expected to occur over time. Adding a 3rd gene target to the plus version of Cepheid's CoV-2/Flu/RSV test delivers broader coverage to mitigate the possible effects of future viral genetic drift.
"This respiratory season, healthcare providers may encounter a range of viral infections with symptoms that overlap with COVID-19, including Flu A, Flu B, and respiratory syncytial virus. Having a fast and accurate test that is designed to detect current and future variants of the viruses that cause COVID-19 and influenza will become increasingly important," said Dr. David Persing, MD, Ph.D., Chief Medical and Technology Officer at Cepheid. "The ability to collect one sample and run a single, highly-sensitive multiplexed test that detects and differentiates all four viruses will provide actionable results to inform better front-line decisions within our healthcare systems."
More on The Californer
- California: Governor Newsom statement on the court temporarily blocking the Trump Administration's unlawful immigration tactics in the Los Angeles area
- Governor Newsom urges Californians to take precautions as state endures triple digit heat, smoky conditions
- Yvette Kendall Secures $6 Million Deal with The Sessions Studios for Horror Thriller, "NORTH"
- Buy The Crave Launches Premium Creatine and Natural Wellness Supplements for Modern Lifestyles
- Long Beach Parks, Recreation and Marine's Homeland Cultural Center Presents DanceFest at Cesar Chavez Park Amphitheater on August 16
Xpert Xpress CoV-2/Flu/RSV plus is expected to begin shipping to US customers in the next few weeks.
Visit www.cepheid.com for more information, videos, and package inserts.
About Cepheid
Based in Sunnyvale, Calif., Cepheid is a leading molecular diagnostics company. 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.
More on The Californer
- Sisu, a Portrait of Grit, Connection and Triumph, Premieres on Documentary Showcase
- New Liz Taylor Book Coming Soon: Chasing Elizabeth Taylor
- City of Long Beach Experienced a 4% Decrease in Fireworks-Related Reports on July 4
- The Blue Luna Encourages Local Schools to Take Steps to Enhance Safety for Students and Staff
- Wise Business Plans Launches Turnkey Startup Packages to Help Entrepreneurs Start and Scale
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.
For Cepheid Media Inquiries:
Darwa Peterson
[email protected]
SOURCE Cepheid
Filed Under: Business
0 Comments
Latest on The Californer
- Easton & Easton, LLP Files Suit Against The Dwelling Place Anaheim & Vineyard USA Over Abuse Allegations
- AI Visibility: The Key to Beating Google's AI Overviews and Regaining Traffic
- First Partner highlights apprenticeship program helping underrepresented youth break into careers in California's iconic entertainment industry
- Stuck Doing Math or Figuring Out Life's Numbers? Calculator.now Makes It Stupidly Simple
- Cal State LA secures funding for two artificial intelligence projects from CSU
- Colbert Packaging Announces WBENC Recognition
- New Mobile Car Detailing Platform Connects Drivers with On-Demand Local Pros
- Over the past three months, California seized $476 million worth of unlicensed cannabis products
- California scores more clean energy records: 9 in 10 days this year partially powered by 100% clean energy
- "Mobile Suit Gundam" Takes Over San Diego Comic-Con 2025
- DivX Empowers Media Enthusiasts with Free Expert Guides for Advanced MP4 Management
- Assent Expands Executive Team to Accelerate Global Growth & Innovation
- The World's Largest Green Economic Revolution Emerges as Nature, Tech, and Finance Converge
- Hamilton Zanze Sponsors the Acquisition of Two Garden-Style Communities in Reno Area
- Meet a Scientologist Captures Greece's Timeless Beauty with Videographer Lambros Malamas
- Vinnetwork Unveils Decentralized AI Platform with Vinnetwork(VIN) Token to Challenge Tech Giants' Data Monopoly
- Moovs Launches Advanced Contact Center Solution for Large-Scale Transportation Operations
- Centennial Flyers to Become Colorado's First Launch Customer for All-Electric B23 Energic Aircraft
- Second Annual Artists' Rights Advocate Award to Be Presented at The Comedy Store on July 17th
- Pyro Marketing Opens New Digital Marketing Company to Power Growth for Fitness and Ecommerce Brands