FDA Streamlines Sales, Testing Process For At-Home Covid Tests
The FDA has changed its rules so that some companies can sell at-home covid tests without having to first test them on asymptomatic people. The move is designed to boost widespread consumer testing as well as efforts for returning to work and school.
Axios:
FDA Moves To Streamline At-Home COVID-19 Test Approval
The Food and Drug Administration announced Tuesday that it will allow some companies developing COVID-19 tests to market their products for regular at-home use without first seeing how they perform on asymptomatic people, Politico reports. The agency hopes the move will streamline emergency-use authorizations for such tests, making it easier to conduct widespread testing of people who may soon be returning to schools and office spaces, the FDA noted in a statement. (Saric, 3/16)
Politico:
FDA Opens Door To Widespread At-Home Covid-19 Tests
The Food and Drug Administration will allow some developers of Covid-19 tests to market their products for regular at-home use without first studying how well the tests perform in people without symptoms. The agency's announcement Tuesday is aimed at making it easier to screen Americans returning to school and work, senior FDA regulators said. (Lim, 3/16)
Boston Globe:
Saliva-Based COVID-19 Test To Be Submitted For Emergency Use Authorization With The FDA
Dr. Angela Slitt was already thinking about surveillance tools for COVID-19 before a single case was identified in Rhode Island. In the beginning days of the pandemic, she monitored the challenges of the common polymerase chain reaction (PCR) tests; how access was severely hampered due to disruptions in the supply chain, how they required extraction of the nucleic acids, access to thermocyclers, and other lab equipment that was both sophisticated and expensive. ... A year later, Slitt and her team have developed a new saliva-based COVID-19 test that overcomes the challenges of PCR tests. This new test, called quantiCOVID-19, is not only less invasive than the nasal swabs that most tests use, but is sensitive, specific, eliminates the supply chain issues, and can deliver results at a lower cost with minimal scientific equipment. (Gagosz, 3/16)
In other covid research news —
Capital & Main:
Baffling Illness In Children Follows In The Wake Of COVID
It was toward the end of last summer that Martha Kuhl began to notice the numbers. With increasing frequency, parents were bringing their kids to the emergency department of UCSF Benioff Children’s Hospital in Oakland, the young patients complaining of an array of symptoms – fever, pain in the stomach or neck, rash, bloodshot eyes – that at first glance appeared to mimic other childhood ailments. “Some of the parents were really afraid that it was COVID-19, and we had been seeing some cases of acute COVID,” said Kuhl, a registered nurse in pediatric oncology at Benioff. “But these were a kind of post-COVID case that was different.” (Disclosure: Kuhl is a member of the California Nurses Association, which is a financial supporter of Capital & Main.) (Kriedler, 3/15)
Axios:
Good Coronavirus Treatments Exist, But How To Get Them Is Complicated
Only a minority of patients are receiving some of the most promising coronavirus treatments. COVID-19 is almost certainly going to be part of our lives for a long time, even with high vaccination rates. Antibody treatments could make it much less deadly — but only if patients get them. (Owens, 3/16)
