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FDA Stops Home Covid-19 Diagnostic Test

Covid-19 illustration

(CDC.gov)

16 May 2020. The Food and Drug Administration asked designers of a Covid-19 test collecting samples at home for research to stop giving results to individuals. The Seattle Coronavirus Assessment Network, or SCAN, a not-for-profit group developing the test, says FDA now requires a separate authorization to return a person’s own diagnostic results.

The SCAN project is a joint initiative of health care researchers and providers in Seattle, including Brotman Baty Institute, Fred Hutchinson Cancer Research Center, Seattle Children’s Hospital, and University of Washington Health, with financial backing from the Bill and Melinda Gates Foundation. As described by Bill Gates in a blog post on 12 May, the SCAN test is designed for disease surveillance, providing evidence of Covid-19’s community spread.

The SCAN test collects specimens from individuals using at-home nasal swabs from mucus in the front of the nose, with Q-tip style collectors, rather than a nasopharyngeal swab that collects specimens of nasal secretions at the back of the throat. In most current tests, long swabs are inserted by a clinician in full protective gear through the patient’s nose to the region where the throat meets the roof of the mouth. As reported by Science & Enterprise, FDA in April cleared a commercial home Covid-19 test using a method similar to SCAN’s for specimen collection.

Nasal swab specimens from individuals are then sent back to a University of Washington lab for genetic analysis. Data from individuals are collected and analyzed further by Institute for Disease Modeling, a computational research lab focusing on infectious diseases that maps the spread of Covid-19 in the region and makes projections about further spread of the disease. The value of surveillance testing, says Gates, is finding Covid-19 cases among people with few or no symptoms, while most current testing protocols call for testing only highly symptomatic cases.

While FDA apparently has no problem with SCAN’s disease surveillance work, the agency raised questions about furnishing participants results from their own specimens. In a statement, SCAN says FDA “recently clarified its guidance for home-based, self-collected samples to test for Covid-19. We have been notified that a separate federal emergency use authorization (EUA) is required to return results for self-collected tests. The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test, but we have been asked to pause testing until we receive that additional authorization.”

SCAN is an offshoot of the Seattle Flu Study, a disease surveillance research project begun in 2018 to track community spread of influenza in the Seattle region. Early in 2020, the Seattle Flu Study team from Brotman Baty Institute revised its technology for the SCAN project. On 1 May, in a letter to New England Journal of Medicine, SCAN researchers reported on the first 2,353 fully collected samples through 9 March that detected SARS-CoV-2 virus in 25 samples, or 1.1 percent. Of those 25 cases, say the authors, only seven sought clinical care.

The SCAN statement notes, “We have been in conversation with the FDA since March 1st and hope to have our EUA soon.”

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