• Skip to main content
  • Skip to secondary menu
  • Skip to footer

Press Media Release

press release distribution

  • Submit a Press Release
  • Market Wire
  • Make a Contribution
  • About
    • Template for press/media release
  • Contact

Coronavirus (COVID-19) Update: FDA Issues first Emergency Use Authorization for Point of Care Diagnostic

March 21, 2020 By admin Leave a Comment

Today, the U.S. Food and Drug Administration issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test.

“The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort. With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them,” said HHS Secretary Alex Azar. “With the development of point of care diagnostics, Americans who need tests will be able to get results faster than ever before. More and more options for reliable, convenient testing are becoming available at an incredibly rapid pace, thanks to the hard work of our FDA team and the ingenuity of American industry.”

“Our dedicated team at the FDA has been working nonstop to expedite the review and authorization of novel diagnostics during the COVID-19 public health emergency,” said FDA Commissioner Stephen Hahn, M.D. “Today marks an important step in expanding the availability of testing and, importantly, rapid results. Point-of-care testing means that results are delivered to patients in the patient care settings, like hospitals, urgent care centers and emergency rooms, instead of samples being sent to a laboratory. With today’s authorization, there is now an option for testing at the point of care, which enables patient access to more immediate results.”

The FDA issued an emergency use authorization to Cepheid for the Xpert Xpress SARS-CoV-2 test for use in high- and moderate-complexity CLIA-certified laboratories as well as in certain patient care settings. The company intends to roll-out availability of its point-of-care testing by March 30.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration
http://www.fda.gov

Filed Under: Press Release Tagged With: COVID-19, Coronavirus

Reader Interactions

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Footer

Recent Posts

  • The Role of Forests in Climate Change Mitigation
  • U.S. Department of State, Bezos Earth Fund, and Rockefeller Foundation Announce Next Steps on Energy Transition Accelerator
  • Social Media Digest
  • COVID-19 Claims 2,000 Lives Per Week; 3 Critical Things Everyone Should Know
  • Economic Uncertainty Rising, 83% of Marketing Leaders to Prioritize Investments in Operational Efficiency and Hiring in 2023
  • PXEF.com adds new AI painting to art gallery: “Rich girl, poor girl in the swimming pool”
  • Market Research Media releases new market research report on the U.S. government market for low-code/no-code software
  • XRY, the MSAB extraction solution, comes with new features centered on ensuring the chain of custody of digital evidence
  • Ultisim Announces Advisory Board
  • Exclusive.org Announces Sale of Exclusive Domains

Media Partners

  • VPNW.com
  • OPINT
  • Digital Market
Five Simple Strategies for Boosting Your Personal Productivity
Watching the sea can be an incredibly relaxing and therapeutic activity
Why companies should think twice before pulling back on work flexibility of remote workers
Employee expectations have undergone a seismic shift
Eating smaller, more frequent meals and cutting calories is a more effective way to manage weight than intermittent fasting
AWS Named Swisscom’s Preferred Public Cloud Provider to Accelerate Digital Transformation Strategy and Move Towards Cloud-Native 5G Network
Bloomberg Increases Carbon Emissions Data to Cover 100,000 Companies
Lender Compliance Technologies Raises $4.15 Million in Series A Funding
Repeat Raises $6 Million in Series A Financing to Help CPG Brands Turn One-Time Buyers Into Repeat Customers
Waiting for Facebook to die
Leading Web3 Platform Vatom Partners with Premiere Music Experiences Company elrow to Unlock the Future of Fan Experiences, Announces International Expansion
Valour Inc., a Subsidiary of DeFi Technologies, Valour announces new incoming CEO
Blockchain.com Rolls Out Crypto Trading in Oklahoma
Industry Briefs
Domains of the day: low-code-no-code.com

Media Partners

  • Media Instances
  • PXEF.com
  • S3H.com
The Art of Blacksmithing: A Lost Craft
Abstract art as an universal language
Perfectionism is associated with a string of mental-health disorders
Stress comes to us all in tiny little assaults throughout the day
Blockchaining 2022
Sanctions Bite: Russian Oligarchs Feel the Squeeze
Sunflowers, Van Gogh-ish
Apple Regains World’s Most Valuable Brand Status
Mongolian manuscript from the 19th century
Post-Covid Travel Season is Here
The Impact of Climate Change on Biodiversity
5G Brings New Threats and Opportunities to Cybersecurity Landscape
Living a longer life is no longer sufficient
Can companies be run like democracies?
AI Hardware Trends 2023

Copyright © 2022 PressMediaRelease.com

Sponsored by Exclusive Domains

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept”, you consent to the use of ALL the cookies.
Do not sell my personal information.
Cookie SettingsAccept
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT