GENE ONLINE|News &
Opinion
Blog

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

by Eduardo Longoria
Share To

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

 

©www.geneonline.com All rights reserved. Collaborate with us: [email protected]
Related Post
World Vaccine Congress Washington 2025 Recap: Urgent Calls for Trust, Tech, and Global Access
2025-04-25
Fake Ozempic Floods Market as FDA Warns Patients to Check Authenticity of Prescriptions
2025-04-16
Breaking New Ground in 2025 with 8 First-in-Class Drugs Close to FDA Approval – Part II
2025-04-01
LATEST
AI-Based Model Accurately Classifies Pediatric Sarcomas Using Digital Pathology Images
2025-04-30
Taiwan’s BPIPO and DCB Join Japan’s LINK-J and FIRM for First Regenerative Medicine Investment Forum in Tokyo
2025-04-29
Study Shows ctDNA Liquid Biopsy Detects Colorectal Cancer Recurrence Earlier Than Imaging
2025-04-29
AACR Annual Meeting 2025: Cancer Research Innovations, NIH Funding Advocacy, and AI-Driven Advances
2025-04-28
Senti Biosciences to Showcase New Cell & Gene Therapy Data at AACR Annual Meeting 2025
2025-04-27
World Vaccine Congress Washington 2025 Recap: Urgent Calls for Trust, Tech, and Global Access
2025-04-25
Astellas’ Transformation Journey: From Merger to Global Player, Betting on the Edge of Innovation and Risk?
2025-04-25
EVENT
2025-04-25
AACR Annual Meeting 2025
Chicago, U.S.A
2025-05-03
29th Taiwan Joint Cancer Conference 2025
Taipei, Taiwan
2025-05-05
Swiss Biotech Day 2025
Basel, Switzerland
2025-05-13
ASGCT 28th Annual Meeting 2025
New Orleans, U.S.A.
2025-05-30
ASCO Annual Meeting 2025
Chicago, U.S.A
2025-06-11
ISSCR 2025 Annual Meeting
Hong Kong
Scroll to Top