Morning RX: June 7, 2023


Cue Health gets FDA’s first de novo approval for at-home COVID-19 test, Novavax says its new vaccine will fight new variants and HHS creates new cert standards for peer support workers.

Cue Health Gets FDA’s First Regular-Use Clearance For At-Home COVID-19 Test

Healthcare tech company Cue Health has received marketing authorization from the FDA for its at-home COVID-19 test, the company announced Tuesday. This marks the first time an at-home COVID-19 test received marketing authorization from the agency using a traditional premarket review pathway. It is also the first authorization granted for any home use respiratory test. The test, which can deliver results in 20 minutes, was approved for an Emergency Use Authorization in 2021. The cartridge-based diagnostic has an overall accuracy of 98% and can detect all known COVID-19 variants.

“Today’s authorization is the first at-home COVID-19 test granted marketing authorization outside of emergency use authorities, representing a new era of consumer access to diagnostic tests that can be performed entirely at home,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a release. “The FDA continues to proactively work with test developers that desire to market their products beyond emergency use authorities. This is part of the FDA’s broader effort to advance the development and availability of at-home tests for a variety of medical conditions to expand patient access to testing.”

Novavax’s New COVID-19 Vaccine Should be Effective Against Latest Variants

A COVID-19 vaccine being produced by biotech company Novavax should be protective against any variants that are currently on the rise, Filip Dubovsky, head of research and development at Novavax, told Reuters. He said the vaccine, which was developed to target the XBB.1.5 variant, should also be effective against the XBB.2.3 variant and any other ones that may be related to it. The company announced earlier this year that it was making the vaccine, but the protein-based product takes longer much longer to develop than the mRNA vaccines from Pfizer and Moderna. A panel of FDA advisers is scheduled on June 15 to meet and discuss strain selection for this year's COVID-19 booster shots.

HHS Publishes Certification Standards for Peer Support Workers

The US Department of Health and Human Services has published national model standards for substance use, mental health, and family peer workers. The announcement on Tuesday said the model standards aim to “accelerate universal adoption, recognition, and integration of the peer workforce across all elements of the healthcare system.” Developed through the Substance Abuse and Mental Health Services Administration, the model standards were created in collaboration with federal, state, tribal, territorial, and local partners, as well as public comment. Peer support workers are individuals who help others deal with substance abuse or mental health issues through their own lived experiences.

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