COVID-19: FDA Grants EUA for First Over-the-Counter, At-Home Test Kit

On December 9th, the FDA granted an emergency use authorization (EUA) for the first non-prescription, over-the-counter COVID-19 test kit for at-home use. The LabCorp Pixel COVID-19 Test Home Collection Kit allows anyone 18 and older to buy the kit and collect nasal swab samples at home.

After the test is done at home, the nasal swabs should be sent to a LabCorp facility for testing. In the event of negative results, the customer will be informed via an online platform, while positive or invalid results are delivered by phone or in person.

LabCorp is a publicly-traded firm based out of North Carolina that has received $850 million in funding since its founding in 1978.

New COVID-19 Antibody Test

“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,” Dr. Jeff Shuren, the director of the FDA’s Center for Devices and Radiological Health, said in a statement.

Image Courtesy: LabCorp

The kit can help individuals understand their COVID-19 status and decide when self-isolation or quarantine may be necessary, the FDA said. It can also help with healthcare decisions after discussions with providers.

After buying the test, users register the kit on the website and follow the included instructions. The test results are then delivered to the consumer via the LabCorp portal, and a healthcare provider will counsel consumers who test positive. While this new test is exciting, LabCorp was sure to emphasize in its news release that the new COVID-19 at-home testing kit is not a substitute for a doctor’s visit.

COVID-19 Testing Environment

A similar test, Lucira COVID-19 All-In-One, is a molecular single-use test that is available only by prescription. This test was made available and granted a EUA last month, but the prescription makes its accessibility much more limited. Despite these limitations, the FDA commissioner, Stephen Hahn, called it a critical development.

The test uses a molecular amplification technology that can return results in 30 minutes and detect the virus in people with known or suspected COVID-19.

Currently, the three main types of tests on the market are molecular tests, such as RT-PCR tests that look for the virus’s genetic material, antibody tests that detect whether a patient ever had a COVID infection, and antigen tests that detect specific proteins from the virus. A molecular COVID-19 test searches for signs of the coronavirus’ RNA.

“This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” Hahn said.

The LabCorp test costs US$ 119 and is also reimbursable for uninsured individuals as a result of legislation from March 2020. This test also has the advantage of being orderable after a simple online questionnaire. There is already a discussion taking place to try to get the test available in retail outlets.

Industry Predictions

While the global population is still increasing, pandemics of this scale could keep repeating in an all the more interconnected world. The lessons learned from this pandemic will encourage radical medical improvements and innovations like at-home testing kits and point of care tests. Innovations such as the LabCorp at-home testing kit will likely become a normal and standard part of dealing with future pandemics and possibly other diseases. Doing this will make doctors more productive and cut down on the state’s costs in using emergency services to bring the physically challenged people in for testing. At-home testing will likely become the standard, and doctor interactions can be more productive when the tests are already done before they see the patient.

By Eduardo Longoria

Related Article: 7 Things to Know About Lucira, the First At-Home COVID-19 Diagnostic Test to Bag FDA’s EUA

References

1. https://www.businesswire.com/news/home/20201209006036/en/LabCorp-Receives-FDA-Authorization-to-Make-At-Home-COVID-19-Collection-Kits-Available-Through-Retail

Related posts:

COVID-19: After Lilly, Regeneron Bags EUA for its Antibody Therapy Moderna Files for USFDA Authorization After Achieving 94.1% Vaccine Efficacy Moderna’s COVID-19 Vaccine Bags FDA’s Emergency Use Authorization, Inoculations to Start on Monday Celltrion Bags FDA’s Emergency Approval for COVID-19 Rapid Test, Prepares to Ship Supply to the US

Author

Eduardo Longoria