Vitros Troponin Assay from QuidelOrtho Receives FDA Clearance for Early Heart Attack Detection

QuidelOrtho Corporation has announced that its Vitros hs Troponin I Assay has been granted 510(k) clearance by the FDA.

The test is intended for the quantitative measurement of cardiac troponin I (cTnI) in human plasma (heparin) samples, to aid in the diagnosis of acute myocardial infarction (AMI).

Troponin I is a key biomarker for cardiac muscle injury. Its accurate, early measurement is crucial for diagnosing AMI and stratifying risk in acute coronary syndromes (ACS).

High-sensitivity (hs) troponin assays, capable of detecting very low levels of troponin and small changes over time, are increasingly considered standard of care in Europe and parts of Asia. Including them in workflows can accelerate diagnosis and help rule out non-AMI cases more rapidly.

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QuidelOrtho said they “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.”

The company cited the fact that studies show that the use of an hs troponin diagnostic can reduce 30-day mortality by 12% and one-year mortality by 10% in patients with suspected ACS.

“High-sensitivity troponin tests consistently improve the accuracy and efficiency of identifying ACS patients for better patient care and outcomes.”

In its press release, QuidelOrtho notes that cardiovascular disease remains the leading cause of death for men and women aged 45+ in the US. In 2023, over 919,000 people in the US died from cardiovascular disease, which is about one in every three deaths.

The company said that the new clearance supports faster, guideline-aligned decision-making in emergency and acute settings.

QuidelOrtho explains that its Vitros systems are built on dry-slide, MicroWell and Intellicheck Technologies, “designed to deliver workflow efficiency, reliability and quality clinical results in laboratories worldwide.”

For labs already running Vitros systems, this clearance allows them to add an hs-cTnI assay without switching platforms. That may reduce the barrier to upgrading to high-sensitivity troponin testing.

“Cardiovascular care depends on speed, accuracy and confidence,” said Jonathan Siegrist, PhD, executive vice president of Research & Development and 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 commercial launch to US laboratories using Vitros systems is expected to begin later this year.