Labcorp Expands Sexually Transmitted Infection (STI) Test Offerings with Rapid Syphilis Test

Rhea-AI Summary

Labcorp (NYSE: LH) has expanded its STI testing portfolio with the First to Know® Syphilis Test, the first FDA-authorized over-the-counter blood test for syphilis. As the exclusive distributor for NOWDiagnostics (NOWDx) in the U.S., Labcorp will offer this rapid test to healthcare providers nationwide by the end of 2024 and to patients through Labcorp OnDemand in 2025.

The test provides results in 15 minutes using a single drop of blood from a fingerstick. This expansion aims to combat the rising syphilis cases in the U.S., which have increased by 80% between 2018 and 2022, reaching over 207,000 reported cases in 2022. Labcorp's syphilis testing volume has more than doubled in the past decade, exceeding 5.5 million tests annually.

Positive

• Exclusive distribution agreement with NOWDiagnostics for the First to Know® Syphilis Test
• Expansion of STI testing portfolio with FDA-authorized rapid syphilis test
• Planned availability to healthcare providers by end of 2024 and patients through Labcorp OnDemand in 2025
• Syphilis testing volume has more than doubled over the past decade, exceeding 5.5 million tests annually

Negative

• None.

Labcorp to serve as the exclusive NOWDiagnostics (NOWDx) distributor for clinical testing in the U.S., offering First to Know® Syphilis Test nationwide

BURLINGTON, N.C., Oct 10, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, announced today it has expanded its portfolio of sexually transmitted infection (STI) testing options to include the First to Know® Syphilis Test, the first over-the-counter blood test granted market authorization by the U.S. Food & Drug Administration (FDA) that can be performed by both physicians and patients.

Labcorp will serve as the exclusive distributor of the First to Know Syphilis Test to providers in healthcare settings nationwide, through an agreement with over-the-counter and point-of-care diagnostic test developer NOWDiagnostics (NOWDx). This new offering reflects Labcorp's commitment to expanding provider and patient access to fast and reliable syphilis tests in an effort to help combat the syphilis epidemic.

U.S. syphilis cases have surged by 80% between 2018 and 2022 to more than 207,000 reported cases in 2022. According to the World Health Organization (WHO), most cases are asymptomatic or undiagnosed, which makes testing critical to diagnosis and treatment. If untreated, syphilis can seriously damage the heart and brain and cause blindness, deafness and paralysis.

"The recent rise in syphilis cases highlights a critical gap in testing and treatment across the country," said Dr. Brian Caveney, Labcorp's chief medical and scientific officer. "This test is another tool in a provider's arsenal as they face this serious public health emergency. Our agreement with NOWDx reflects our commitment to providing healthcare providers and patients across the country with access to tests that deliver fast and reliable results that empower them to make informed decisions about their health."

Labcorp will leverage its scale as one of the largest diagnostics laboratories in the world to facilitate widespread availability of the First to Know Syphilis Test, which provides a result in 15 minutes with as little as a single drop of blood collected through a fingerstick. Physicians can utilize the test in clinical settings or give it to a patient to conduct in the comfort of their own home. Labcorp plans to make the test available to providers by the end of 2024 and directly to patients through Labcorp OnDemand in 2025.

"Labcorp's strong infrastructure and commitment to advancing diagnostic technology and making testing widely accessible make it the ideal partner to help expand access to our tests and tackle critical public health issues, such as the rise in syphilis cases," said Robert Weigle, CEO of NOWDx. "Together, we aim to ensure our cutting-edge, user-friendly tests are within reach for more patients and healthcare providers, ultimately enhancing early identification and treatment outcomes."

As the FDA has noted, results from the First to Know Syphilis Test alone are not sufficient to diagnose syphilis infection and should be followed by additional testing to confirm a diagnosis of syphilis.

Labcorp currently offers treponemal and non-treponemal assays recommended by the Centers for Disease Control and Prevention (CDC) for the screening and diagnosis of syphilis. The company has seen syphilis testing volume more than double over the past decade, exceeding 5.5 million tests annually.

For more information, contact diagnosticsales@labcorp.com.

About Labcorp
Labcorp (NYSE: LH) is a global leader of innovative and comprehensive laboratory services that helps doctors, hospitals, pharmaceutical companies, researchers and patients make clear and confident decisions. We provide insights and advance science to improve health and improve lives through our unparalleled diagnostics and drug development laboratory capabilities. The company's more than 67,000 employees serve clients in approximately 100 countries, provided support for 84% of the new drugs and therapeutic products approved in 2023 by the FDA and performed more than 600 million tests for patients around the world. Learn more about us at www.labcorp.com.

About NOWDiagnostics (NOWDx)
NOWDx develops and manufactures over-the-counter (OTC) and point-of-care (POC) diagnostic tests. Its patented approach enables virtually any immunological assay to be accurately performed onsite in one step using a small amount of capillary blood, yielding results in minutes. With over 75 patents issued and pending, NOWDx's First To Know® and ADEXUSDx® product lines are available in markets worldwide. Founded in 2013, with headquarters and manufacturing in Springdale, Arkansas, NOWDx envisions a world where people have greater access to in-home testing with results in minutes. The company's investors include Kompass Kapital Management, DigitalDx Ventures and the Labcorp Venture Fund. NOWDx is committed to changing healthcare by providing accessible, affordable, and accurate testing for all. Please visit nowdx.com for more information.

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SOURCE Labcorp

FAQ

What is the new syphilis test Labcorp (LH) is offering?

Labcorp is offering the First to Know® Syphilis Test, the first FDA-authorized over-the-counter blood test for syphilis that can be performed by both physicians and patients.

When will Labcorp (LH) make the First to Know® Syphilis Test available?

Labcorp plans to make the test available to healthcare providers by the end of 2024 and directly to patients through Labcorp OnDemand in 2025.

How long does it take to get results from the First to Know® Syphilis Test offered by Labcorp (LH)?

The First to Know® Syphilis Test provides results in 15 minutes using a single drop of blood collected through a fingerstick.

What is the current trend in syphilis cases according to Labcorp's (LH) press release?

According to the press release, U.S. syphilis cases have surged by 80% between 2018 and 2022, with more than 207,000 reported cases in 2022.