On July18, 2023, the FDA released a Class I tag on the Quidel Triage Cardiac Panel, which means usage of the product may lead to serious injury or death without action. There were numerous complaints received that demonstrated that the test’s ability to detect troponin was faulty as it showed lower-than-expected troponin levels. This could lead to a delayed or even missed diagnosis of myocardial infarction. Against the backdrop, the FDA recall of the Triage Cardiac Panel is a massive blow to the multi-parameter cardiac marker tests market in the US, says GlobalData, a leading data and analytics company.

According to GlobalData’s Stock Keeping Unit (SKU) Tracker, the Triage Cardiac Panel dominates the multi-parameter cardiac marker tests market in the US with almost 100% share since 2014 to February 2023. The SKU tracker covers 1,300 US hospitals, 450 distribution centres, 250 physician offices, and 380 clinics across the US.

Selena Yu, Medical Analyst, at GlobalData, comments: “According to the FDA database, there are currently 16,194 Quidel Triage Cardiac Panels in commerce globally. Therefore, this recall will not only delay myocardial infarction care across the US but can also cause a ripple of delays globally as other government health departments may also issue recalls. With QuidelOrtho as the sole leader in the US market for the past couple years, facilities may not have stockpiles of other tests to continue during multi-parameter testing during this recall.”

QuidelOrtho’s revenue from multi-parameter tests in the cardiac marker tests market in the US stood at 1.87% in 2022. Furthermore, by market share value, QuidelOrtho holds 19.68% of the market, with Roche and Abbott leading with 26.63% and 21.56%, respectively.

Yu concludes: “With the multiparameter test only making up 0.38% of total market value in the US, the total market will now be severely impacted. Moreover, since the Triage Test contributes to 1.87% of QuidelOrtho’s Cardiac Marker Test revenue, this recall will not impact QuidelOrtho’s revenue severely. There may be drops in sales after the recall as facilities may be hesitant to repurchase or have replaced the Triage with another test. However, it is important to note that since QuidelOrtho holds 100% of the multiparameter test market, the segment may drop in market share for 2023.”