Monday, May 23, 2022
News on Pathogens and Preparedness
Global Biodefense
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe
No Result
View All Result
Global Biodefense
No Result
View All Result
Home Biodetection

FDA Authorizes Flowflex COVID-19 Home Test from ACON Laboratories

by Global Biodefense Staff
October 4, 2021
Coronavirus-Like Particles Could Ensure Reliability of Simpler, Faster COVID-19 Tests

Credit: NIAID

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the ACON Laboratories Flowflex COVID-19 Home Test, an over-the-counter (OTC) COVID-19 antigen test in an effort to increase access to testing for consumers.

The Flowflex COVID-19 Antigen Home Test is a simple nasal swab test which will soon be available for purchase without a prescription in major retail stores and online. It may be used for self-testing by individuals aged 14 years and older, or with adult-collected nasal swabs from children as young as 2 years old.

In contrast to other home tests which require testing twice within a two-to-three-day period (a process known as serial screening), the Flowflex COVID-19 Antigen Home Test has been authorized for use as a single test by individuals with or without symptoms. This will allow for the distribution of more affordable single-test packaging, resulting in greater access to home testing.

Flowflex COVID-19 tests are already available in many countries outside the U.S., including widespread distribution in the UK through the National Health Service (NHS). The international popularity of this test has led ACON to greatly expand global production capacity at multiple manufacturing sites. This emergency use authorization will now allow ACON to quickly respond to the unmet demand for simple and inexpensive home diagnostics as a critical tool in the fight against COVID-19.

By years end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022, according to a statement by the FDA.

Sources: FDA, ACON Laboratories

Tags: COVID-19Editor PickEmergency Use AuthorizationRapid DiagnosticsSARS-CoV-2

Related Posts

NIH to Further Invest in Point-of-Care Technologies Research Network
Biodetection

NIH to Further Invest in Point-of-Care Technologies Research Network

May 10, 2022
Where is Testing Needed Most During Pandemic Surges? WVU Researchers Develop Machine Learning Prediction Tools
Biodetection

Where is Testing Needed Most During Pandemic Surges? WVU Researchers Develop Machine Learning Prediction Tools

May 6, 2022
Rapid COVID-19 PCR Test Developed at Northwestern Receives FDA Emergency Use Authorization
Biodetection

Rapid COVID-19 PCR Test Developed at Northwestern Receives FDA Emergency Use Authorization

March 19, 2022
There’s No Such Thing as Just-in-Time Healthcare and Public Health Preparedness
Industry News

Appili Awarded $10M in New Biodefense Funding for Tularemia Vaccine Candidate

March 3, 2022
Load More

Latest News

NIH to Further Invest in Point-of-Care Technologies Research Network

NIH to Further Invest in Point-of-Care Technologies Research Network

May 10, 2022

How a COVID-19 Infection Spurs Antibodies Against Common Colds

May 8, 2022
Hospitals Resilience to Extreme Events: One-Third of Staff May Be Lost During a Disaster

Hospitals Resilience to Extreme Events: One-Third of Staff May Be Lost During a Disaster

May 6, 2022
Where is Testing Needed Most During Pandemic Surges? WVU Researchers Develop Machine Learning Prediction Tools

Where is Testing Needed Most During Pandemic Surges? WVU Researchers Develop Machine Learning Prediction Tools

May 6, 2022

Subscribe

  • About
  • Contact
  • Privacy
  • Subscribe

© 2022 Stemar Media Group LLC

No Result
View All Result
  • Featured
  • COVID-19
  • Funding
  • Directory
  • Jobs
  • Events
  • Subscribe

© 2022 Stemar Media Group LLC