Labcorp Receives Emergency Use Authorization for First Non-Prescription At-Home Collection Kit for Combined COVID-19, Flu and RSV Detection

Rhea-AI Summary

Labcorp (NYSE: LH) has received Emergency Use Authorization (EUA) from the FDA for a new at-home collection kit that tests for COVID-19, influenza A/B, and RSV. This combined kit offers reliable PCR testing from the comfort of home, aimed at individuals aged 2 and older. Tests can be ordered through Labcorp OnDemand without a prescription and may incur no upfront cost for those with insurance. Labcorp has conducted over 74 million COVID-19 tests and continues to innovate in response to respiratory virus prevalence.

Positive

• Emergency Use Authorization received for a combined COVID-19, influenza A/B, and RSV testing kit.
• Kit provides convenient at-home testing and may be available at no cost for insured individuals.
• Labcorp has performed over 74 million COVID-19 tests, enhancing its credibility in the market.

Negative

• Kit has not been FDA cleared or approved, only authorized under EUA, indicating potential limitations.
• The test is only authorized for the duration of emergency use, adding uncertainty to its availability.

New Offering Enhances Portfolio of Leading COVID-19 PCR Testing Options

Combined Kit Provides People with Trusted Answers from the Comfort of Their Homes

BURLINGTON, N.C.--(BUSINESS WIRE)-- Labcorp (NYSE: LH), a leading global life sciences company, today announced the receipt of Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a combined at-home collection kit available that simultaneously detects COVID-19, influenza A/B and respiratory syncytial virus (RSV), a common but contagious respiratory virus often seen in children.

Photo courtesy of Labcorp

The Pixel by Labcorp COVID-19+Flu+RSV Test Home Collection Kit will be available for use by individuals age 2 and older through the Labcorp OnDemand™ digital health platform without a prescription. For those who meet clinical guidelines and have insurance, the kit is available at no upfront cost. By using the Labcorp kit to determine whether they have contracted COVID-19, flu or RSV, individuals are choosing the reliability of PCR testing—considered the gold standard for diagnosing COVID-19 and its variants—to make key health decisions.

“Labcorp’s COVID-19 tests have been trusted by physicians and millions of people throughout the pandemic. This new at-home collection kit makes it easier for consumers to access testing for multiple respiratory viruses – COVID-19, the flu and RSV – that can present similar symptoms,” said Dr. Brian Caveney, chief medical officer and president of Labcorp Diagnostics. “With the spike in RSV cases over the last year, the continued presence of COVID-19, and the ever-present threat of flu, testing for all three viruses at once enables individuals and physicians to quickly identify the illness and determine the appropriate treatment.”

The Pixel by Labcorp COVID-19+Flu+RSV Test Home Collection Kit is shipped via FedEx Priority Overnight to an individual’s home. Once collected, the sample is returned to Labcorp via a prepaid return envelope. Test results are available through an individual’s Labcorp OnDemand account 1-2 days on average after Labcorp receives the completed collection kit.

If a person tests positive, they will receive a call from a third-party physician network with detailed next steps and access to a free clinician consult. Clinical guidelines for receiving the kit at no upfront cost with insurance include experiencing symptoms, being exposed to someone with COVID-19, or receiving a request to get tested from a health care provider. This test is only intended for individuals experiencing flu-like symptoms.

The new at-home test collection kit is the latest example of Labcorp’s commitment to delivering innovations that help physicians, health systems and consumers respond to the pandemic. Labcorp, a leader in COVID-19 testing with more than 74 million tests performed, continues to be a key contributor to the pandemic response. The company is consistently working to expand COVID-19 testing access and further the development of COVID-19 vaccines and therapies.

Labcorp’s combined home collection kit for COVID-19, influenza A/B and RSV has not been FDA cleared or approved and has been authorized by the FDA under an emergency use authorization only for the detection of nucleic acid from SARS-CoV-2, influenza A and/or influenza B, and RSV, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About Labcorp

Labcorp is a leading global life sciences company that provides vital information to help doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations to improve health and improve lives. With more than 75,000 employees, we serve clients in more than 100 countries. Labcorp (NYSE: LH) reported revenue of $16 billion in FY2021. Learn more about us at www.Labcorp.com or follow us on LinkedIn and Twitter @Labcorp.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220517006327/en/

Labcorp Contacts:

Media: Christopher Allman-Bradshaw — 336-436-8263

Media@Labcorp.com

Investors: Chas Cook — 336-436-5076

Investor@Labcorp.com

Source: Labcorp

FAQ

What is the new offering by Labcorp regarding COVID-19 testing?

Labcorp has launched an at-home collection kit that tests for COVID-19, influenza A/B, and RSV.

What is the significance of the Emergency Use Authorization received by Labcorp?

The EUA allows Labcorp to provide a new combined testing kit without prior FDA approval, enhancing access to testing.

How does Labcorp's new kit improve testing accessibility?

The kit can be ordered online without a prescription and may incur no upfront cost for insured patients.

What are the conditions for receiving Labcorp's at-home testing kit at no upfront cost?

Individuals must meet clinical guidelines, including experiencing symptoms or being exposed to a confirmed case.

How many COVID-19 tests has Labcorp conducted to date?

Labcorp has performed over 74 million COVID-19 tests, marking it as a leader in the testing market.