QuidelOrtho Receives FDA 510(k) Clearance for VITROS™ Immunodiagnostic Products hs Troponin I Assay

Clearance expands menu and enables high-sensitivity troponin I measurement to aid in the diagnosis of myocardial infarction

SAN DIEGO, Nov. 3, 2025 /PRNewswire/ -- The U.S. Food and Drug Administration ("FDA") has granted QuidelOrtho Corporation (Nasdaq: QDEL) ("QuidelOrtho"), a global leader of in vitro diagnostics, 510(k) clearance for the VITROS hs Troponin I Reagent Pack (the "VITROS hs Troponin I Assay"). The assay is intended for the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) to aid in the diagnosis of myocardial infarction (MI).

"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 U.S. laboratories operating VITROS Systems will begin later this year. For ordering information, validation support or technical documentation, customers should contact their QuidelOrtho representative. 

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 by 10% 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.

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SOURCE QuidelOrtho Corporation