The U.S. FDA has made it easier for people who want to get tested for COVID-19, granting emergency use authorization (EUA) for direct-to-consumer sales of Laboratory Corporation of America Holdings’ (LabCorp) Pixel COVID-19 test home collection kit. With this latest EUA, any individual 18 years and older can purchase the Pixel test system without a prescription.
Pixel is authorized as the first nonprescription COVID-19 test system to allow an individual to self-collect a nasal swab sample at home and then send it to LabCorp for testing. If results are positive or invalid, a health care provider will call to discuss the outcome. Negative test results will be delivered via email or an online portal.
The home sample collection kit can be purchased online or in a store without a prescription. By authorizing OTC use, the FDA hopes to increase users’ access to information about their COVID-19 infection status, which could aid in determining if they should quarantine and inform decisions about appropriate care after discussion with a health care professional.
Expanding access to testing
“This is the first kit for consumers to self-collect a nasal sample for COVID-19 in their home that does not require a prescription,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health. “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.”
The authorization comes as new cases of the novel coronavirus are raging across the U.S., straining the health care systems and state and local resources. On Dec. 9, the daily death toll surpassed 3,000.
Brian Caveney, chief medical officer and president of LabCorp Diagnostics said giving people access to an over-the-counter at-home collection kit for COVID-19 will empower them take responsibility for their health. “With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”
Speaking at the recent Evercore ISI Healthconx virtual conference, LabCorp CEO Adam Schechter said the company can now do 270 tests a day and deliver results in one to two days. To increase capacity, the company has automated a lot of its processes, such as pipetting, which has allowed for fast turnarounds despite increasing demand.
Growing array of home test options
The FDA authorized the first at-home collection system for COVID-19 in mid-March, expanding the original EUA for LabCorp’s polymerase chain reaction (PCR) test for SARS-CoV-2 to include the Pixel self-collection kit. The move was a portent of a wider testing strategy to restore the U.S. economy to normalcy. To date, the FDA has issued EUAs for more than a dozen tests that provide for collection of samples at home. All but the OTC version of the Pixel COVID-19 test require a doctor’s prescription.
In November, Emeryville, Calif.-based Lucira Health Inc. became the first company to obtain FDA emergency use authorization for a prescription molecular diagnostic test for COVID-19 that can be performed from start to finish in the convenience of one’s home. The single-Use, COVID-19 All-in-One Test Kit utilizes a simple ‘swab, stir and detect’ design that yields results within 30 minutes, enabling individuals who suspect they have the virus to get results while isolating at home.
That EUA followed fulfilled another FDA goal. During a September diagnostic town hall, Tim Stenzel, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said the agency was eager to authorize a test that could be used at home without medical supervision, but had yet to receive any EUA filings.
Now with prescription-free availability of LabCorp’s Pixel COVID-19 test system, consumers have one more option for smart and convenient testing.
At last month’s Credit Suisse Healthcare Conference, LabCorp CEO Adam Schechter said the Pixel at-home tests have been around for years, but few people used them. With COVID-19, “now people understand and Pixel’s become almost a household name.”
He added there may be opportunities for LabCorp to do other at-home collections in the future.
LabCorp shares (NYSE: LH) hit a high of $208.19 on Thursday afternoon before ending the day at $207.59, up 2.58% from the previous day’s close of $202.57.