QuidelOrtho Receives FDA 510(k) Clearance for VITROS™ Immunodiagnostic Products hs Troponin I Assay
Rhea-AI Summary
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.
Positive
- 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
Negative
- None.
News Market Reaction – QDEL
On the day this news was published, QDEL gained 2.67%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
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)?
