NOWDiagnostics and Labcorp Collaborate to Expand Access to the Only FDA-Marketing Authorized Over-the-Counter Syphilis Test in the U.S.
NOWDiagnostics (NOWDx) has announced a collaboration with Labcorp to distribute its First To Know® Syphilis Test in professional and healthcare settings across the U.S. This FDA-authorized over-the-counter test provides results in 15 minutes using a drop of blood. Labcorp plans to offer the test to professionals and hospitals by the end of 2024 and directly to patients through Labcorp OnDemand in 2025.
The collaboration aims to address the 80% increase in syphilis cases since 2018, affecting over 207,000 people, including more than 3,700 newborns in 2022. The partnership will expand access to testing, supporting earlier detection and treatment. Labcorp will also be the U.S. distribution partner for NOWDx's ADEXUSDx® hCG test used in hospital settings.
NOWDiagnostics (NOWDx) ha annunciato una collaborazione con Labcorp per distribuire il suo Test per la Sifilide First To Know® in ambito professionale e sanitario negli Stati Uniti. Questo test da banco autorizzato dalla FDA fornisce risultati in 15 minuti utilizzando una goccia di sangue. Labcorp prevede di offrire il test ai professionisti e agli ospedali entro la fine del 2024 e direttamente ai pazienti tramite Labcorp OnDemand nel 2025.
La collaborazione mira a affrontare l'aumento dell'80% dei casi di sifilide dal 2018, che ha colpito oltre 207.000 persone, comprese più di 3.700 neonati nel 2022. La partnership amplierà l'accesso ai test, supportando una diagnosi e un trattamento più precoci. Labcorp sarà anche il partner di distribuzione negli Stati Uniti per il test ADEXUSDx® hCG di NOWDx utilizzato in contesti ospedalieri.
NOWDiagnostics (NOWDx) ha anunciado una colaboración con Labcorp para distribuir su Prueba de Sífilis First To Know® en entornos profesionales y de atención médica en los EE. UU. Esta prueba de venta libre autorizada por la FDA proporciona resultados en 15 minutos utilizando una gota de sangre. Labcorp planea ofrecer la prueba a profesionales y hospitales para finales de 2024 y directamente a los pacientes a través de Labcorp OnDemand en 2025.
La colaboración tiene como objetivo abordar el aumento del 80% en los casos de sífilis desde 2018, afectando a más de 207,000 personas, incluidos más de 3,700 recién nacidos en 2022. La asociación ampliará el acceso a pruebas, apoyando la detección y el tratamiento más tempranos. Labcorp también será el socio de distribución en EE. UU. para la prueba ADEXUSDx® hCG de NOWDx que se utiliza en entornos hospitalarios.
NOWDiagnostics (NOWDx)는 미국의 전문 의료 환경에서 First To Know® 매독 검사를 배포하기 위해 Labcorp와 협력한다고 발표했습니다. 이 FDA 승인 OTC 검사는 혈액 한 방울을 사용하여 15분 안에 결과를 제공합니다. Labcorp는 2024년 말까지 전문가와 병원에 검사를 제공할 계획이며, 2025년에는 Labcorp OnDemand를 통해 환자에게 직접 제공할 예정입니다.
이번 협력은 2018년 이후 매독 사례가 80% 증가한 것에 대응하기 위한 것으로, 2022년에는 20만 7천 명 이상, 이 중 3,700명 이상의 신생아에게 영향을 미쳤습니다. 파트너십은 검사의 접근성을 확대하고 조기 발견 및 치료를 지원할 것입니다. Labcorp는 또한 NOWDx의 ADEXUSDx® hCG 검사의 미국 배급 파트너가 될 것입니다.
NOWDiagnostics (NOWDx) a annoncé une collaboration avec Labcorp pour distribuer son Test de Syphilis First To Know® dans les milieux professionnels et de santé aux États-Unis. Ce test en vente libre autorisé par la FDA fournit des résultats en 15 minutes avec une goutte de sang. Labcorp prévoit d'offrir le test aux professionnels et aux hôpitaux d'ici fin 2024 et directement aux patients via Labcorp OnDemand en 2025.
La collaboration vise à répondre à l'augmentation de 80 % des cas de syphilis depuis 2018, touchant plus de 207 000 personnes, dont plus de 3 700 nouveau-nés en 2022. Ce partenariat élargira l'accès au dépistage, soutenant une détection et un traitement plus précoces. Labcorp sera également le partenaire de distribution aux États-Unis pour le test ADEXUSDx® hCG de NOWDx utilisé dans les hôpitaux.
NOWDiagnostics (NOWDx) hat eine Zusammenarbeit mit Labcorp bekannt gegeben, um seinen First To Know® Syphilis Test in professionellen und gesundheitlichen Einrichtungen in den USA zu vertreiben. Dieser von der FDA genehmigte Test zum Verkauf liefert Ergebnisse innerhalb von 15 Minuten mit einem Tropfen Blut. Labcorp plant, den Test bis Ende 2024 Fachleuten und Krankenhäusern anzubieten und 2025 direkt an Patienten über Labcorp OnDemand.
Die Zusammenarbeit zielt darauf ab, den 80%igen Anstieg der Syphiliserkrankungen seit 2018 anzugehen, die über 207.000 Menschen betreffen, darunter mehr als 3.700 Neugeborene im Jahr 2022. Die Partnerschaft wird den Zugang zur Testung erweitern, was eine frühere Erkennung und Behandlung unterstützt. Labcorp wird auch der Vertriebspartner in den USA für NOWDx's ADEXUSDx® hCG-Test sein, der in Krankenhauseinstellungen eingesetzt wird.
- Exclusive U.S. distribution agreement with Labcorp for the First To Know® Syphilis Test
- Expansion of test availability to professional and hospital settings by end of 2024
- Direct-to-patient offering through Labcorp OnDemand planned for 2025
- Labcorp to distribute NOWDx's ADEXUSDx® hCG test for hospital use
- None.
Insights
The collaboration between NOWDiagnostics and Labcorp to distribute the First To Know® Syphilis Test is a significant development in the fight against rising syphilis cases. This FDA-authorized over-the-counter test provides results in just 15 minutes, potentially revolutionizing syphilis detection and treatment.
Key points to consider:
- Syphilis cases have surged by
80% since 2018, affecting over 207,000 people in the U.S. - The test will be available in professional and healthcare settings by the end of 2024 and directly to patients through Labcorp OnDemand in 2025
- This expansion in accessibility could lead to earlier detection and treatment, potentially reducing complications and transmission rates
For Labcorp (LH), this collaboration could strengthen its position in the diagnostic market, particularly in the growing STI testing segment. However, the financial impact may be in the short term, as the full rollout won't occur until 2025.
This partnership represents a strategic move for Labcorp (LH) to expand its diagnostic offerings in the rapidly growing STI testing market. The collaboration aligns with increasing demand for accessible and rapid diagnostic solutions, particularly in light of the alarming rise in syphilis cases.
Market implications:
- Potential for increased revenue streams from professional, hospital and direct-to-consumer channels
- Enhanced competitive positioning in the STI testing market
- Alignment with the trend towards decentralized, rapid testing solutions
While the immediate financial impact may be modest, the long-term potential is significant as the product gains traction and expands to direct-to-consumer channels. Investors should monitor the adoption rates and any subsequent impact on Labcorp's diagnostics segment revenue in the coming years.
As syphilis cases surge nationwide, the collaboration will bring the First To Know® over-the-counter test to clinicians and patients across professional and hospital settings
First To Know® Syphilis Test With Box - Credit NOWDiagnostics (Photo: Business Wire)
“Our collaboration with Labcorp marks a pivotal moment for NOWDx as we scale up access to our First To Know® Syphilis Test across the U.S.,” said Rob Weigle, CEO of NOWDx. “Labcorp’s confidence in our patented touch-to-test technology, along with their longstanding relationships in professional and hospital settings, ensures this critical diagnostic tool is available to more clinicians. Our retail and public health efforts, which will be announced shortly, alongside Labcorp’s initiatives in the professional and hospital settings, will increase access to testing. This will help support earlier detection and treatment as we address the concerning rise in syphilis cases by providing high-quality, easy-to-use diagnostics."
Syphilis cases in the
“NOWDx’s innovative testing technology is a valuable addition to our syphilis portfolio, and we are pleased to work with them to expand access to the First To Know® Syphilis Test,” said Dr. Brian Caveney, Chief Medical and Scientific Officer at Labcorp. “With syphilis cases rising nationwide, we see a pressing need for accessible testing solutions that empower providers and patients on the path to treatment.”
This collaboration underscores Labcorp and NOWDx’s shared commitment to providing better diagnostic options and improving health outcomes nationwide. Labcorp will also be the
For more information about NOWDx and its full suite of diagnostic solutions, please visit www.nowdx.com.
About First To Know® Syphilis Test
The First To Know® Syphilis Test is a patented buffer-less lateral flow device that provides a qualitative rapid membrane immunochromatographic assay for detecting Treponema pallidum (syphilis) antibodies in human whole blood (capillary) from individuals suspected of having a syphilis infection. First to Know® received marketing authorization from the FDA through the de novo pathway recognizing it as a novel device for syphilis testing in
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
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
View source version on businesswire.com: https://www.businesswire.com/news/home/20241016877731/en/
Media Contacts:
For NOWDx
Alexander Romero-Wilson
alexander@healthandcommerce.com
For Labcorp
Kimbrel Arculeo
Media@Labcorp.com
Source: NOWDiagnostics, Inc.
FAQ
What is the First To Know® Syphilis Test by NOWDiagnostics?
When will Labcorp (LH) start offering the First To Know® Syphilis Test?
How has the syphilis rate changed in recent years according to the NOWDiagnostics press release?
What other NOWDiagnostics product will Labcorp (LH) distribute in the U.S.?
