Why-FDA stopped Covid-19 Home-Testing

Why-FDA stopped Covid-19 Home-Testing
Why-FDA stopped Covid-19 Home-Testing

Why-FDA stopped Covid-19 Home-Testing

Covid-19 testing by SCAN, (Seattle Coronavirus Assessment Network) was stopped on Thursday following a call from the Food and Drug Administration (FDA), which proposed that SCAN required further federal authorization to continue the program.

SCAN, which had been working in partnership with Washington state and county public health officials, conducted home tests for the virus and processed the results of the self-administered nasal swabs. In February, SCAN researchers uncovered evidence of the primary instance of community spread of the virus therein area. After the notice from the FDA, the program is prohibited from both accepting new tests and providing those that have already taken the test with results.

“The Food & Drug Administration (FDA) presently made known its policies for home-based, self-collected samples to be analyzed for COVID-19,” reported by a Thursday press release from SCAN. “It was brought to our notice that a separate federal emergency use authorization (EUA) is needed to submit results for self-collected tests. The FDA has not raised any concerns regarding the safety and accuracy of SCAN’s test, but we’ve been asked to pause testing until we receive that additional authorization.”

Why-FDA stopped Covid-19 Home-Testing

SCAN had received support from Gates Ventures, a risk capital firm started by Microsoft founder Gates . In a Tuesday blog post, Gates praised the program as how to elevate the understanding of the spread of the virus throughout Seattle and round the world.

Needing more validation, the FDA stopped the efforts of a Washington State group analyzing in-home testing.

Recently, the FDA are yet to approve any in-home testing kits. However, in April, LabCorp  one at-home test was awarded an emergency use validation by the FDA. Previously, only given access to health care providers, the test enables consumers to swab their own noses and send the samples to a laboratory for further investigation.

Why-FDA stopped Covid-19 Home-Testing

EUAs are often issued to “allow unapproved medical products or unapproved uses of approved medical products” in an emergency to treat serious medical conditions, like coronavirus.

Hydroxychloroquine, a malaria drug touted by President Donald Trump as a possible therapeutic for the virus, received an EUA from the FDA and is a component of the Strategic National Stockpile. Hospitals may ask for the drug from the stockpile as a cure for the disease. Clinical trials of the drug, administered with the antibiotic azithromycin, began within the U.S. on Thursday.

Studies in other countries have cast doubt on the effectiveness of hydroxychloroquine within the fight against coronavirus. An April study of the drug published within the U.K. did not “accept the fact that hydroxychloroquine is efficient for the management of  mild COVID-19 symptoms.”


Why-FDA stopped Covid-19 Home-Testing

Karen Whitsett, the Michigan Democratic State Representative appreciated the drug in April, giving a review that it “saved her life.” When she experienced a rapid onrush of coronavirus symptoms, Whitsett took hydroxychloroquine which she credits for creating her feel better “within a few hours.”

“Had President Trump not talked about this,” Whitsett said, “it wouldn’t have been accessible for anyone to get, not immediately.”


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