FDA Approves First Direct-to-consumer, Non-prescription Covid-19 Test System

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The U.S. Food and Drug Administration Wednesday authorized LabCorp's Pixel Covid-19 Test Home Collection kit, that can be used without prescription by people of age 18 years and older.

Using this first direct-to-consumer Covid-19 test system one can self-collect nasal swab sample and send that to LabCorp for testing.

Positive or invalid results are informed through phone call by a healthcare provider, while negative results are sent through email or online portal.

Pixel test system is intended to enable users to access information about their Covid-19 infection status and take required steps to assist with health care decisions.

"While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing," said Jeff Shuren, M.D., J.D., director of FDA's Center for Devices and Radiological Health.

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