FDA Approves First Home Test For Covid-19, However Not In New York State

The FDA has granted an emergency use authorization to LabCorp through its’  satellite company, Pixel to be the first company permitted to enable citizens to self-administer the COVID-19 test at home.

“Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” said Dr. Stephan Hahn, Commissioner of the FDA.

The lab kit box is available for $119. “We’ll send you an at-home kit to collect your nasal swab sample and ship it back to our lab.  Our lab will test your sample for SARS-CoV-2, the virus that causes coronavirus disease (also called COVID-19), a respiratory illness” is the message of Pixel’s website. However, the same site says, “Pixel by LabCorp™ is not available in NY, NJ, MD, or RI due to restrictions on how laboratory tests may be ordered.  Please talk with your healthcare provider about options for getting tested.”

The kit that includes a “Q-Tip” type cotton-swab and some saline solution in a container. An acceptable doctor’s RX must be obtained to receive the kit.

“It is important to note that this is not a general authorization for at-home collection of patient samples using other collection swabs, media, or tests, or for tests fully conducted at home,” the FDA said.

“The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers,” Hahn continued.

“…For tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site,” he concluded.