FDA clears development, sale of at-home COVID-19 tests

The FDA posted new guidelines May 6 that allow manufacturers to develop and market COVID-19 test kits that could be used by people at home and mailed to any lab in the country, a move the agency hopes will significantly increase U.S. testing capacity, The New York Times reported. 

The guidelines allow companies to develop diagnostic kits with tools for people to collect their own samples and mail them to any lab in the country. 

The FDA reviewed studies conducted by UnitedHealthcare and funded by the Bill & Melinda Gates Foundation that tested the accuracy of self-collected samples that spent several days in a dry plastic tube at high temperatures to make sure the samples collected would survive in the mail, according to the Times

But experts have questioned if commercial labs have the capacity to process large quantities of self-collected samples. 

The FDA also said it hopes the guidelines will speed the production of inexpensive diagnostic tests that could be ordered online or purchased at pharmacies without a physicians' order, according to the Times

Read the full article here.


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