FDA OKs New Test That Identifies Signs Of Past Covid Infection
Adaptive Biotechnologies' test is the first of its kind to receive emergency authorization from the FDA. The agency also approved another over-the-counter test from Cue Health.
Stat:
FDA Authorizes New Test To Detect Past Covid-19 Infections
The Food and Drug Administration on Friday issued an emergency authorization for a new test to detect Covid-19 infections — one that stands apart from the hundreds already authorized. Unlike tests that detect bits of SARS-CoV-2 or antibodies to it, the new test, called T-Detect COVID, looks for signals of past infections in the body’s adaptive immune system — in particular, the T cells that help the body remember what its viral enemies look like. Developed by Seattle-based Adaptive Biotechnologies, it is the first test of its kind. (Palmer, 3/5)
Axios:
FDA Authorizes Over-The-Counter Coronavirus Test
The Food and Drug Administration on Friday issued an emergency use authorization for a COVID-19 test for home and other over-the-counter uses. The single-use test, developed by Cue Health, may increase the availability of reliable coronavirus tests in the United States, potentially allowing Americans to avoid trips to the doctor’s office or a testing site. (Knutson, 3/5)
In other testing news —
Politico:
Biden Team Plots The Country’s First National Covid Testing Strategy
The Biden administration is preparing to launch the first of several Covid-19 testing hubs to coordinate and oversee a $650 million expansion of testing in K-8 schools and congregate settings like homeless shelters. The Department of Health and Human Services hopes to open the first hub in April, as part of a public-private partnership that could eventually add up to 25 million tests per month to the nation’s testing totals, two sources briefed on the plans told POLITICO. Administration officials discussed details of the program on Tuesday during a call with industry, government agencies and state and local health departments. They held a second industry call on Thursday. (Lim, 3/7)
Axios:
A Worrying Decline In COVID Testing
Daily COVID-19 tests in the U.S. have declined by more than a quarter since mid-January. Even with cases and deaths falling dramatically in recent weeks, the pandemic is far from finished, and less demand for testing could put us a step behind the spread. (Walsh, 3/6)
And in Japan, you can grab a test on the run —
Reuters:
In Japan, Vending Machines Help Ease Access To COVID-19 Tests
In Japan, convenience is king and getting tested for COVID-19 can be highly inconvenient. Part of solution, as it is for a range of daily necessities in Tokyo, has become the humble vending machine. Eager to conserve manpower and hospital resources, the government conducts just 40,000 polymerase chain reaction (PCR) tests a day, a quarter of its capacity, restricting them to people who are quite symptomatic or have had a high chance of being infected. That’s led to the public to rely heavily on private clinics or buying PCR tests by other means. (Sakai and Swift, 3/8)
