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