First At-Home COVID-19 Test Approved by FDA
The Pixel testing kit will cost $119 and will require permission from a doctor to obtain.
The first at-home coronavirus testing kit has been given emergency approval by the Food and Drug Administration.
In a statement on Tuesday, the FDA said it approved the diagnostic kit, called “Pixel,” made by Laboratory Corporation of America (LabCorp). The government agency also added that LabCorp was reissued emergency use authorization (EUA) to test the samples at their facilities. To receive a kit, patients will need to get approval from a doctor after completing a COVID-19 questionnaire.
The FDA’s EUA program allows the agency to authorize the use of an unapproved medical product or an unapproved use of an approved medical product during a serious public health emergency like the coronavirus.
The Pixel self-collection kits will include a nasal swab and saline. Patients will need to swab the inside of their nose, place the sample into the insulated package, and mail it to LabCorp’s lab. The FDA says the kits are set to be available in most states sometime in the coming weeks.
FDA Commissioner Dr. Stephen M. Hahn said they made sure this at-home kit was “as safe and accurate as sample collection at a doctor’s office, hospital or other testing site.”
“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,” he continued. “With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”
LabCorp said it will first make the kits available to health care workers and first responders who may have been exposed to the virus. The company’s website said the kits will cost $119, which includes two-way, overnight shipping.
The FDA notes that the Pixel kits are the only authorized at-home testing kits available. Fake testing kits and treatments for coronavirus have circulated since March, with experts warning of the dangers of non-government approved products. Last month, several companies rushed to ship at-home test kits, and the FDA reissued guidance against using those tests.