ARTICLE SUMMARY:
The NIH’s RADx program has helped scores of companies accelerate their rapid, home testing programs for COVID-19 and may have implications beyond the pandemic. One of the first companies to receive an EUA for a home test, Ellume, believes the work it did on COVID-19 is applicable to its broader infectious disease pipeline.
After months of criticism for being too cautious, the FDA has issued eight emergency use authorizations (EUAs) for rapid home COVID-19 testing as of April 6—five of them since early March. That’s good news for the US and rest of the world, as accurate, easy-to-use, and inexpensive tests—millions of them on a weekly basis—will be needed to return to pre-pandemic normalcy.
The feat is all the more notable because prior to COVID-19, the FDA was exceedingly cautious about authorizing over-the-counter (OTC) diagnostic home tests and had never approved any for respiratory infectious diseases. Technological hurdles and long-standing concerns that home tests are subjectively interpreted and therefore prone to error by users, and furthermore, there may be no way to catch such errors because providers are not involved, kept the FDA, clinicians, and industry experts at bay.
