VITROS® Syphilis Assay Now Available on VITROS 3600 Immunodiagnostic System, VITROS 5600 and VITROS XT 7600 Integrated Systems in the U.S.
QuidelOrtho (Nasdaq: QDEL) has received FDA 510(k) clearance for its VITROS syphilis assay, now available on VITROS 3600, 5600, and XT 7600 systems in the U.S. This automated assay detects total antibodies to Treponema pallidum in human serum and plasma, aiding in syphilis diagnosis. The launch addresses the growing syphilis epidemic in the U.S., with over 176,000 new cases reported annually and a 36% increase in primary and secondary syphilis since 2021.
The VITROS syphilis assay improves laboratory efficiency by allowing labs to follow the CDC's reverse testing algorithm for syphilis screening. It also reduces costs through earlier disease detection, minimizing the need for external lab referrals. This expansion aims to provide timely and accurate diagnosis, important for effective treatment and disease control.
QuidelOrtho (Nasdaq: QDEL) ha ricevuto l'approvazione FDA 510(k) per il suo test per la sifilide VITROS, ora disponibile sui sistemi VITROS 3600, 5600 e XT 7600 negli Stati Uniti. Questo test automatizzato rileva gli anticorpi totali contro Treponema pallidum nel siero e nel plasma umano, supportando la diagnosi di sifilide. Il lancio affronta l'emergenza sifilide in crescita negli Stati Uniti, con oltre 176.000 nuovi casi segnalati annualmente e un aumento del 36% dei casi di sifilide primaria e secondaria dal 2021.
Il test per la sifilide VITROS migliora l'efficienza del laboratorio consentendo ai laboratori di seguire l'algoritmo di testing inverso del CDC per lo screening della sifilide. Inoltre, riduce i costi grazie a una diagnosi precoce della malattia, minimizzando la necessità di riferimenti a laboratori esterni. Questa espansione mira a fornire diagnosi tempestive e accurate, fondamentali per un trattamento efficace e il controllo della malattia.
QuidelOrtho (Nasdaq: QDEL) ha recibido la aprobación 510(k) de la FDA para su prueba de sífilis VITROS, ahora disponible en los sistemas VITROS 3600, 5600 y XT 7600 en EE. UU. Esta prueba automatizada detecta anticuerpos totales contra Treponema pallidum en suero y plasma humano, apoyando el diagnóstico de sífilis. El lanzamiento aborda la creciente epidemia de sífilis en EE. UU., con más de 176,000 nuevos casos reportados anualmente y un aumento del 36% en sífilis primaria y secundaria desde 2021.
La prueba de sífilis VITROS mejora la eficiencia del laboratorio al permitir que los laboratorios sigan el algoritmo de pruebas inversas de los CDC para la detección de sífilis. También reduce costos mediante la detección temprana de la enfermedad, minimizando la necesidad de referencias a laboratorios externos. Esta expansión tiene como objetivo proporcionar diagnósticos oportunos y precisos, importantes para un tratamiento eficaz y el control de la enfermedad.
QuidelOrtho (Nasdaq: QDEL)는 미국에서 VITROS 3600, 5600 및 XT 7600 시스템에서 사용할 수 있는 VITROS 매독 검사에 대해 FDA 510(k) 승인을 받았습니다. 이 자동화된 검사는 인간의 혈청 및 혈장에서 Treponema pallidum에 대한 총 항체를 검출하여 매독 진단을 돕습니다. 이번 출시는 미국 내 증가하는 매독 유행에 대응하며, 매년 176,000건 이상의 신규 사례가 보고되고 있으며, 2021년 이후 1차 및 2차 매독의 발생이 36% 증가했습니다.
VITROS 매독 검사는 실험실 효율성을 향상시켜 CDC의 매독 스크리닝을 위한 역행 테스트 알고리즘을 따를 수 있도록 합니다. 또한 조기 질병 발견을 통해 외부 실험실 의뢰의 필요성을 최소화하여 비용을 줄입니다. 이 확장은 효과적인 치료와 질병 통제를 위해 중요한 적시 정확한 진단을 제공하는 것을 목표로 합니다.
QuidelOrtho (Nasdaq: QDEL) a reçu l'approbation FDA 510(k) pour son test de syphilis VITROS, désormais disponible sur les systèmes VITROS 3600, 5600 et XT 7600 aux États-Unis. Ce test automatisé détecte les anticorps totaux contre Treponema pallidum dans le sérum et le plasma humains, aidant ainsi au diagnostic de la syphilis. Le lancement répond à l'épidémie croissante de syphilis aux États-Unis, avec plus de 176 000 nouveaux cas signalés chaque année et une augmentation de 36 % des cas de syphilis primaire et secondaire depuis 2021.
Le test de syphilis VITROS améliore l'efficacité des laboratoires en permettant aux laboratoires de suivre l'algorithme de test inverse des CDC pour le dépistage de la syphilis. Il réduit également les coûts grâce à une détection précoce de la maladie, minimisant ainsi le besoin de références vers des laboratoires externes. Cette expansion vise à fournir des diagnostics rapides et précis, essentiels pour un traitement efficace et le contrôle de la maladie.
QuidelOrtho (Nasdaq: QDEL) hat die FDA 510(k)-Zulassung für seinen VITROS Syphilis-Test erhalten, der jetzt in den VITROS 3600, 5600 und XT 7600 Systemen in den USA verfügbar ist. Dieser automatisierte Test erkennt Gesamtantikörper gegen Treponema pallidum im menschlichen Serum und Plasma und unterstützt die Diagnose von Syphilis. Der Launch richtet sich an die wachsende Syphilis-Epidemie in den USA, mit über 176.000 neu gemeldeten Fällen jährlich und einem Anstieg von 36 % bei primärer und sekundärer Syphilis seit 2021.
Der VITROS Syphilis-Test verbessert die Effizienz der Labore, indem er den Laboratorien ermöglicht, dem umgekehrten Testalgorithmus der CDC für das Screening von Syphilis zu folgen. Er senkt auch die Kosten durch frühzeitige Krankheitsdiagnose und minimiert die Notwendigkeit von externen Laborüberweisungen. Diese Erweiterung zielt darauf ab, zeitnahe und genaue Diagnosen bereitzustellen, die für eine effektive Behandlung und Krankheitskontrolle wichtig sind.
- FDA 510(k) clearance received for VITROS syphilis assay
- Expansion of infectious disease test portfolio in the U.S. market
- Improved laboratory efficiency through CDC's reverse testing algorithm
- Cost reduction potential through earlier disease detection
- Addresses growing syphilis epidemic with 176,000+ new cases annually
- None.
Insights
The FDA clearance of QuidelOrtho's VITROS syphilis assay marks a significant advancement in infectious disease testing. This automated test, now available on multiple VITROS systems, offers improved efficiency and earlier detection capabilities. The assay's ability to detect both IgG and IgM antibodies provides a comprehensive screening tool, aligning with the CDC's reverse testing algorithm for syphilis.
Notably, this launch comes at a critical time, with syphilis cases in the U.S. increasing by
QuidelOrtho's strategic expansion of its infectious disease test portfolio with the VITROS syphilis assay positions the company to capitalize on the growing demand for STI testing. With over
This launch could potentially boost QuidelOrtho's market share in the infectious disease testing segment. By reducing the need for outsourced testing, the company may see increased adoption rates among healthcare providers, potentially leading to improved revenue streams and strengthened customer relationships in the competitive diagnostics market.
QuidelOrtho Receives FDA 510(k) Clearance for its VITROS Syphilis Assay
VITROS® XT 7600 Integrated System (Photo: Business Wire)
QuidelOrtho’s infectious disease test portfolio spans the healthcare continuum from point-of-care settings to high-throughput laboratories and is critical in addressing the growing syphilis epidemic in the
“As an in-demand assay for a common sexually transmitted infection (‘STI’), we are pleased to offer the VITROS syphilis assay, bolstering QuidelOrtho’s infectious disease test portfolio in the U.S.,” said Bryan Hanson, Senior Vice President, President North American Commercial Operations at QuidelOrtho. “Not only does this important assay improve laboratory efficiency by allowing labs to follow the CDC’s reverse testing algorithm for syphilis screening, it also reduces costs by providing earlier disease detection, thereby reducing the need to refer tests to outside labs.”
This expansion into the U.S. market aims to provide timely and accurate diagnosis, crucial for effective treatment and control of the disease.
“With an increased national incidence of syphilis and other STIs, having a quick and easy way to test in various healthcare settings is essential,” said Lily Li, Senior Director, Medical Scientific & Clinical Affairs, QuidelOrtho. “The CDC Morbidity and Mortality Weekly Report, updated in February 2024, recommends that both nontreponemal and treponemal serologic tests be used in conjunction to aid in the diagnosis of syphilis.”
QuidelOrtho continues to expand its menu for infectious disease testing and beyond to help our customers provide the highest level of patient care.
Sources:
CDC. Syphilis Statistics 2022. Accessed June 27, 2024. https://www.cdc.gov/std/statistics/2022/overview.htm#Syphilis.
CNN. Maternal Syphilis Rates Surge. Accessed June 27, 2024. https://www.cnn.com/2024/02/13/health/maternal-syphilis-rates-surge-infant-risk/index.html#:~:text=That%27s%20about%
CDC. Media Release on STI Rates. Accessed June 27, 2024. https://www.cdc.gov/media/releases/2023/s0411-sti.html.
About QuidelOrtho Corporation
QuidelOrtho Corporation (Nasdaq: QDEL) is a world leader in in vitro diagnostics, developing and manufacturing intelligent solutions that transform data into understanding and action for more people in more places every day.
Offering industry-leading expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine, bringing fast, accurate and reliable diagnostics when and where they are needed – from home to hospital, lab to clinic. So that patients, clinicians and health officials can spot trends sooner, respond quicker and chart the course ahead with accuracy and confidence.
Building upon its many years of groundbreaking innovation, QuidelOrtho continues to partner with customers across the healthcare continuum and around the globe to forge a new diagnostic frontier. One where insights and solutions know no bounds, expertise seamlessly connects and a more informed path is illuminated for each of us.
QuidelOrtho is advancing diagnostics to power a healthier future.
For more information, please visit www.quidelortho.com.
Source: QuidelOrtho Corporation
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FAQ
What is the VITROS syphilis assay and what FDA clearance did it receive?
How does the VITROS syphilis assay benefit laboratories and patients?
What is the current state of syphilis in the U.S. according to the press release?
How does QuidelOrtho's VITROS syphilis assay align with CDC recommendations?
