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Alexander: FDA Approval of Reliable, Low-Cost, At Home Diagnostic Test is “A Genuine Breakthrough” in COVID-19 Testing

Says breakthrough is the result of extraordinary efforts of the National Institutes of Health’s “Shark Tank”

WASHINGTON, December 15, 2020 — Senate health committee Chairman Lamar Alexander (R-Tenn.) today released the following statement on the Food and Drug Administration’s approval of Ellume’s new over-the-counter, at-home diagnostic COVID-19 test:


“This is a genuine breakthrough in COVID-19 testing. A low-cost, reliable test that can be bought over-the-counter without a prescription and taken at home in 15 minutes. This is the result of the extraordinary efforts of the National Institutes of Health’s ‘Shark Tank,’ or RADx initiative, which has produced 22 new ways to create tens of millions of diagnostic tests in the last 8 months.”


Alexander and Senate health appropriations committee Chairman Roy Blunt (R-Mo.) led an effort in April to pass funding for the competitive “Shark Tank” at NIH so it could work in coordination with the Biomedical Advanced Research and Development Authority (BARDA) and the private sector to fast track new technologies designed to produce tens of millions of tests.


More about Ellume’s test, according to NIH:


Two unique test cartridges contain a single-use, digital fluorescent immunoassay antigen test that returns accurate results in 15 minutes or less. One cartridge testing nasal swabs can be read out on two platforms by healthcare professionals, at the point of care or in laboratory settings for higher throughput. A second cartridge is being developed for home use with a self-administered nasal swab.