FDA extends shelf life of some popular COVID tests

[Image courtesy of Abbott]The FDA announced today that certain COVID-19 diagnostic tests under emergency use authorization now have a longer shelf life.

Diagnostics made by Abbott, Maxim Biomedical and iHealth Labs all received extensions for their expiration dates.

The Abbott BinaxNow COVID-19 antigen self tests now have a shelf life of 22 months. Previously, the popular test had a 15-month shelf life.

Maxim Biomedical’s ClearDetect COVID-19 antigen home test initially received authorization with an eight-month shelf life. The FDA announced that it extended the shelf life of that test to 12 months.

iHealth Labs COVID-19 antigen rapid tests received a three-month extension from 12 months to 15 months.

“The expiration dates for these tests have been extended to reflect the longer shelf-life,” the FDA said in a notice. The agency based its extension on additional data provided by the manufacturers. This data demons…

Read more
  • 0

NIH to boost COVID-19 testing capabilities

[Photo by Fusion Medical Animation on Unsplash]

The National Institutes of Health announced a $129.3 million plan to support scaling and manufacturing for COVID-19 tests.

As part of its Rapid Acceleration of Diagnostics (RADx) initiative, NIH is awarding contracts to nine companies for their technologies that include portable point-of-care tests for immediate results and high-throughput laboratories that can produce results in 24 hours.

Yesterday’s announcement follows a July investment in seven companies from NIH worth $248.7 million in new technologies to address challenges with COVID-19 testing.

Some of the testing technologies are also being supported by the Biomedical Advanced Research and Development Authority (BARDA) as part of the U.S. Dept. of Health and Human Services, along with Defense Advanced Research Projects Agency (DARPA), in the U.S. Defense Dept.

Here are the nine co…

Read more
  • 0