Labcorp partners with NOWDx to expand syphilis testing options

USA—Labcorp, a global leader in laboratory services, has expanded its portfolio of sexually transmitted infection (STI) testing options by introducing the First to Know® Syphilis Test.

This addition comes shortly after the U.S. Food & Drug Administration (FDA) granted market authorization for NOWDiagnostics’ Know Syphilis Test, marking it as the first over-the-counter blood test for syphilis that both physicians and patients can use.

Through an exclusive agreement with NOWDiagnostics (NOWDx), a developer of over-the-counter and point-of-care diagnostic tests, Labcorp will distribute the First to Know Syphilis Test to healthcare providers nationwide.

This expansion highlights Labcorp’s ongoing commitment to broadening access to fast and reliable syphilis testing, with the goal of addressing the increasing number of syphilis cases across the United States.

Between 2018 and 2022, syphilis cases in the U.S. surged by 80%, with over 207,000 cases reported in 2022.

According to the World Health Organization (WHO), many syphilis cases remain asymptomatic or undiagnosed, making timely testing essential for proper diagnosis and treatment.

If left untreated, syphilis can lead to severe health complications, including damage to the heart, brain, and nervous system, potentially causing blindness, deafness, and paralysis.

Commenting on this surge, Dr. Brian Caveney, Labcorp’s chief medical and scientific officer, noted that the recent rise in syphilis cases highlights a critical gap in testing and treatment.

He added that the First to Know Syphilis Test is an essential tool in the hands of healthcare providers as they confront this public health emergency.

He explained that the agreement with NOWDx demonstrates Labcorp’s dedication to ensuring that both providers and patients have access to tests that deliver quick, reliable results, enabling informed healthcare decisions.

Echoing these sentiments, NOWDx CEO Robert Weigle remarked that Labcorp’s extensive infrastructure and commitment to advancing diagnostic technology make it the ideal partner to increase access to their tests.

Together, they aim to ensure that these cutting-edge, user-friendly tests reach more patients and providers, ultimately improving early identification and treatment outcomes for syphilis.

Labcorp plans to use its vast resources, as one of the largest diagnostic laboratories in the world, to facilitate the broad distribution of the First to Know Syphilis Test.

The test provides results within 15 minutes using just a single drop of blood collected through a fingerstick.

Physicians can administer the test in clinical settings or give it to patients for at-home use. Labcorp aims to make the test available to providers by the end of 2024 and to patients via Labcorp OnDemand by 2025.

The FDA has emphasized that results from the First to Know Syphilis Test should be followed by additional testing to confirm a syphilis diagnosis, as the test alone is not sufficient for definitive diagnosis.

Labcorp already offers a range of treponemal and non-treponemal assays recommended by the Centers for Disease Control and Prevention (CDC) for syphilis screening and diagnosis.

Over the past decade, the company’s syphilis testing volume has more than doubled, now surpassing 5.5 million tests annually.

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