At-home COVID-19 testing is getting a major boost as federal health agencies invest in bringing more products to market.
The Department of Health and Human Services announced this week that the National Institutes of Health will pump $70 million into identifying and moving high-quality testing products through the federal approval pipeline. Tests that meet Food and Drug Administration quality standards will be granted emergency use authorization, the agencies said. The funds will come from the American Rescue Plan.
“Working hand-in-hand with FDA, NIH will produce the precise data needed to make authorization decisions quickly,” National Institutes of Health Director Francis S. Collins, M.D., Ph.D., said in the statement.
The Biden Administration has committed to increasing the supply of testing products by December. As part of this plan, and along with approving more test products, the FDA may also allow some developers to add a single-use testing options to their product lines, potentially allowing more individual sales for a lower price.
Manufacturers are betting on demand for at-home tests as well. Becton Dickinson, a maker of one of the tests shipped free by the federal government to nursing homes in the fall of 2020, has partnered with Amazon to ship a new at-home rapid test direct to consumers. The BD Veritor At-Home COVID-19 Test uses a smartphone app to confirm test results and can report results to public health authorities, Reuters reported.
The FDA, meanwhile, also has reissued the EUA for the Quidel QuickVue At-Home OTC COVID-19 Test as a single test, and issued a new EUA for the Celltrion DiaTrust COVID-19 Ag Home Test, an OTC COVID-19 diagnostic antigen test used over two days.
As of Tuesday, Oct. 26, the FDA has authorized 420 tests and sample collection devices, including 16 antigen tests and eight molecular tests for serial screening programs.
