QuidelOrtho Receives FDA 510(k) Clearance for VITROS™ Immunodiagnostic Products hs Troponin I Assay
QuidelOrtho (Nasdaq: QDEL) announced FDA 510(k) clearance for the VITROS hs Troponin I Assay on November 3, 2025.
The assay measures cardiac troponin I in human plasma (heparin) to aid diagnosis of myocardial infarction and integrates with existing VITROS Systems and workflows. The company said U.S. commercial rollout for laboratories running VITROS Systems will begin later this year. QuidelOrtho highlighted studies showing hs troponin pathways can reduce 30-day mortality by 12% and 1-year mortality by 10% in suspected acute coronary syndrome patients.
QuidelOrtho (Nasdaq: QDEL) ha annunciato l'autorizzazione FDA 510(k) per il VITROS hs Troponin I Assay il 3 novembre 2025.
Il test misura la troponina I cardiaca nel plasma umano (eparinato) per supportare la diagnosi di infarto miocardico e si integra con i sistemi VITROS esistenti e con i relativi flussi di lavoro. L'azienda ha detto che il rollout commerciale negli Stati Uniti per i laboratori che eseguono i sistemi VITROS inizierà nel corso di quest'anno. QuidelOrtho ha evidenziato studi che mostrano che i percorsi della troponina hs possono ridurre la mortalità a 30 giorni del 12% e la mortalità a 1 anno del 10% nei pazienti con sospetto di sindrome coronarica acuta.
QuidelOrtho (Nasdaq: QDEL) anunció la aprobación 510(k) de la FDA para el VITROS hs Troponin I Assay el 3 de noviembre de 2025.
La prueba mide la troponina I cardíaca en plasma humano (heparina) para ayudar en el diagnóstico de infarto de miocardio e integra con los sistemas y flujos de trabajo VITROS existentes. La compañía dijo que el despliegue comercial en Estados Unidos para laboratorios que ejecutan sistemas VITROS comenzará a finales de este año. QuidelOrtho destacó estudios que muestran que las vías de troponina hs pueden reducir la mortalidad a los 30 días en un 12% y la mortalidad a 1 año en un 10% en pacientes con sospecha de síndrome coronario agudo.
QuidelOrtho (나스닥: QDEL)가 2025년 11월 3일 FDA 510(k) 승인을 받아 VITROS hs Troponin I Assay를 발표했습니다.
이 분석은 인간 혈장(헤파린)에서의 심근 트로포닌 I를 측정하여 심근경색 진단을 돕고 기존의 VITROS 시스템 및 워크플로우와 통합됩니다. 회사는 VITROS 시스템을 운영하는 실험실을 위한 미국 내 상용화 출시가 올해 말 시작될 것이라고 밝혔습니다. QuidelOrtho는 hs 트로포닌 경로가 의심되는 급성 관상동맥 증후군 환자에서 30일 사망률을 12% 감소시키고 1년 사망률을 10% 감소시킬 수 있다는 연구를 강조했습니다.
QuidelOrtho (Nasdaq : QDEL) a annoncé l'autorisation FDA 510(k) pour le VITROS hs Troponin I Assay le 3 novembre 2025.
Le test mesure la troponine I cardiaque dans le plasma humain (héparine) pour aider au diagnostic de l'infarctus du myocarde et s'intègre aux systèmes et flux VITROS existants. L'entreprise a déclaré que le déploiement commercial américain pour les laboratoires utilisant les systèmes VITROS débutera plus tard cette année. QuidelOrtho a mis en évidence des études montrant que les voies de troponine hs peuvent réduire la mortalité à 30 jours de 12% et la mortalité sur un an de 10% chez les patients présentant un syndrome coronarien aigu suspecté.
QuidelOrtho (Nasdaq: QDEL) gab die FDA 510(k)-Freigabe für den VITROS hs Troponin I Assay am 3. November 2025 bekannt.
Der Test misst das kardiale Troponin I im menschlichen Plasma (Heparin) zur Unterstützung der Diagnose eines Herzinfarkts und integriert sich in vorhandene VITROS-Systeme und Arbeitsabläufe. Das Unternehmen sagte, dass der US-weite kommerzielle Rollout für Labors, die VITROS-Systeme verwenden, später in diesem Jahr beginnen wird. QuidelOrtho hob Studien hervor, die zeigen, dass hs-Troponin-Wege die 30-Tage-Mortalität um 12% und die 1-Jahres-Mortalität um 10% bei Verdacht auf akutes Koronarsyndrom senken können.
QuidelOrtho (بورصة ناسداك: QDEL) أعلنت عن موافقة FDA 510(k) لـ VITROS hs Troponin I Assay في 3 نوفمبر 2025.
يقيس الاختبار تروبونين القلب I في مصل الدم البشري (هيبارين) للمساعدة في تشخيص احتشاء عضلة القلب ويتكامل مع أنظمة VITROS الحالية وسير العمل. قالت الشركة إن الإطلاق التجاري في الولايات المتحدة للمختبرات التي تشغّل أنظمة VITROS سيبدأ في وقت لاحق من هذا العام. أبرزت QuidelOrtho دراسات تُظهر أن مسارات التروبونين hs يمكن أن تقلل الوفيات خلال 30 يوماً بنسبة 12% و الوفيات خلال سنة بنسبة 10% لدى مرضى الاشتباه بمتلازمة التاجية الحادة.
- FDA 510(k) clearance for VITROS hs Troponin I Assay (Nov 3, 2025)
- Assay provides quantitative cTnI measurement in human plasma (heparin)
- Commercial rollout in U.S. labs operating VITROS Systems begins later in 2025
- Studies cited: 30-day mortality −12% and 1-year mortality −10% with hs troponin pathways
- None.
Insights
FDA 510(k) clearance for the VITROS hs Troponin I Assay expands high‑sensitivity troponin capability on VITROS Systems and enables U.S. commercial rollout later this year.
QuidelOrtho adds a quantitative high‑sensitivity cardiac troponin I test intended for use in human plasma (heparin). The assay targets faster, guideline‑aligned diagnosis of myocardial infarction and integrates with existing VITROS Systems and workflow technologies.
Clinical impact depends on lab adoption, local validation and clinician pathways; rollout timing and support logistics matter because commercial distribution begins later this year. The announcement cites population impact data such as
Watch commercial adoption metrics and lab validation uptake in the months after rollout, the speed of integration into emergency/acute care workflows, and any real‑world performance summaries submitted by laboratories; expect initial measurable signals within the first 6–12 months after U.S. distribution begins.
Clearance expands menu and enables high-sensitivity troponin I measurement to aid in the diagnosis of myocardial infarction
"Cardiovascular care depends on speed, accuracy and confidence," said Jonathan Siegrist, PhD, Executive Vice President of Research & Development & Chief Technology Officer. "With FDA clearance of our VITROS hs Troponin I Assay, clinicians using VITROS Systems can access high-sensitivity cardiac troponin testing that fits seamlessly into existing workflows and supports timely, guideline-aligned decision-making in emergency and acute settings."
The VITROS Systems are built on dry-slide, MicroWell and INTELLICHECK™ Technologies designed to deliver workflow efficiency, reliability and quality clinical results in laboratories worldwide. To learn more about VITROS Systems, visit: VITROS Systems | QuidelOrtho.
"Behind every test result is a person and a family. As part of our ongoing commitment to our clinically impactful cardiac menu, our VITROS hs Troponin I Assay can help clinicians evaluate suspected heart attacks with speed and confidence. With this FDA clearance, laboratories running VITROS Systems can bring that capability to more patients consistently, when minutes matter," said Siegrist.
The commercial rollout for
Why this clearance matters:
- Heart disease is the leading cause of death for men and women aged 45 and over, and for most racial and ethnic groups in the
U.S. - Every 34 seconds, someone in the
U.S. dies from cardiovascular disease. - In 2023, 919,032 people in the
U.S. died from cardiovascular disease, about 1 in every 3 deaths. - High-sensitivity troponin assays can save more lives by identifying patients having a heart attack earlier, allowing faster rule out of low-risk patients and improving clinical outcomes for both patient groups. Studies show that implementing an hs troponin pathway can reduce 30-day mortality by
12% and 1-year mortality by10% in patients with suspected acute coronary syndrome ("ACS"). High-sensitivity troponin tests consistently improve the accuracy and efficiency of identifying ACS patients for better patient care and outcomes.
About QuidelOrtho Corporation
With expertise spanning clinical chemistry, immunoassay, immunohematology and molecular testing, QuidelOrtho Corporation (Nasdaq: QDEL) is a leading global provider of diagnostic solutions, delivering fast, accurate and reliable results that help improve patient outcomes – from the point of care to hospital, lab to clinic. Building on a legacy of innovation, QuidelOrtho works with healthcare providers to advance diagnostics that connect insights with solutions, defining a clearer path for informed decisions and better care.
QuidelOrtho is dedicated to advancing diagnostics to power a healthier future. For more information, please visit quidelortho.com and follow QuidelOrtho on LinkedIn, Facebook and X.
Investor Contact:
Juliet Cunningham
Vice President, Investor Relations
IR@QuidelOrtho.com
Media Contact:
D. Nikki Wheeler
Senior Director, Corporate Communications
media@QuidelOrtho.com
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SOURCE QuidelOrtho Corporation
FAQ
What did QuidelOrtho (QDEL) announce on November 3, 2025 about the VITROS hs Troponin I Assay?
How will the VITROS hs Troponin I Assay affect hospitals using VITROS Systems (QDEL)?
When will U.S. laboratories get the VITROS hs Troponin I Assay from QuidelOrtho (QDEL)?
What clinical benefit did QuidelOrtho cite for hs troponin pathways in the announcement?
What sample type is the VITROS hs Troponin I Assay intended for according to QuidelOrtho (QDEL)?
