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Coronavirus (COVID-19) Update: FDA Authorizes First Direct-to-Consumer COVID-19 Test System

Test system is authorized for at-home sample collection with laboratory test processing

Today, the U.S. Food and Drug Administration authorized LabCorp’s Pixel COVID-19 Test Home Collection Kit for use by any individual 18 years and older without a prescription. This product, which is authorized as the first COVID-19 direct-to-consumer (non-prescription) test system, allows an individual to self-collect a nasal swab sample at home and then send that sample for testing to LabCorp. Positive or invalid test results are then delivered to the user by phone call from a health care provider. Negative test results are...