QuidelOrtho received FDA 510(k) clearance for its VITROS hs Troponin I Reagent Pack on November 3 2025, enabling high‑sensitivity troponin I testing on VITROS Systems.
The assay uses dry‑slide, MicroWell, and INTELLICHECK™ technologies to provide quantitative measurement of cardiac troponin I in plasma, supporting rapid diagnosis of myocardial infarction in emergency settings.
The clearance expands QuidelOrtho’s high‑margin consumable revenue stream and strengthens its position in the cardiovascular diagnostics market. The company’s Labs segment, which accounts for a significant portion of revenue, will benefit from the new assay’s integration into existing workflows.
QuidelOrtho’s recent financial results show a Q2 2025 earnings surprise with EPS of $0.12, and the company completed a $3.4 billion debt refinancing. The company’s full‑year 2025 revenue guidance remains $2.6 billion to $2.81 billion, indicating continued growth despite declining COVID‑19 revenues.
The high‑sensitivity troponin market is projected to reach $19.05 billion by 2030, and the new assay positions QuidelOrtho to capture a larger share of this expanding segment. The company also pursues growth in molecular diagnostics, including a potential acquisition of LEX Diagnostics, and continues to focus on operational efficiencies to enhance margins.
A Class I recall of QuidelOrtho’s triage cardiac panel in June 2023 due to lower‑than‑expected troponin detection highlights the critical nature of accurate cardiac biomarker testing.
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