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Congresswoman Urges Biden to Expedite Authorizations of COVID-19 At-Home Tests

NEW YORK ─ US Rep. Kim Schrier (D-Washington) is urging the Biden Administration to make rapid, at-home COVID-19 tests more broadly available in the US.

In a letter dated Oct. 7 Schrier called on President Joseph Biden to issue "an executive order providing an expedited approval pathway that recognizes tests already approved in the European Union."

While 36 rapid antigen tests that have received Emergency Use Authorizations for diagnosing COVID-19, none have received full approval from the US Food and Drug Administration.

Schrier's call for action comes in the wake of the White House COVID-19 Response Team's announcement Wednesday that the Biden administration will invest an additional $1 billion to expand access to SARS-CoV-2 rapid antigen tests.

She said the new funding will provide more access to COVID-19 rapid antigen tests, but "Even with the surge of newly authorized [Acon Laboratories'] FlowFlex tests in addition to the rapid tests currently on the market, we will still lack the capacity to truly optimize the use of these tests as they are intended." She added, "We need a plan now to bridge the gap until supply can meet demand."

Rapid antigen tests, including home-based assays, have become broadly used in European countries such as the UK and Germany where they are inexpensive, and governments have made them a key part of their COVID-19 containment strategies. In the US, however, home tests have remained in short supply, with only a small number of companies selling them, and typically at prices considerably higher than in Europe.

"The most efficient way to ramp up supply is to provide access to the dozens of test that have already received approval from an equally rigorous approval process," Schrier said in her letter. "The European Union has recognized 138 rapid antigen tests that provide accurate results. The United Kingdom has 36 at-home tests that have passed validation. Germany has 36 tests approved for self-use."

The US, by comparison, has approved only three test that are "currently available for consumers to purchase," the congresswoman added.

Schrier advocates more frequent screening of asymptomatic individual, with all students getting tested two to three times a week. "Right now, to test the over 50 million K-12 students in America two times a week, we need over 100 million tests a week," which translates to four billion tests for a full school year, she wrote.