FDA Grants 510(k) Clearance to Roche’s Tina-quant Molarity Assay

Roche has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Tina-quant Lipoprotein (a) Gen.2 Molarity assay, marking a milestone in cardiovascular diagnostics. This clearance makes it the first assay in the US to measure lipoprotein (a), or Lp(a), in nanomoles per litre (nmol/L). 

Lp(a) is a key biomarker in assessing cardiovascular disease risk. The National Lipid Association (NLA) recommends that all adults undergo Lp(a) measurement at least once to evaluate their risk for cardiovascular disease. Elevated Lp(a) levels have been linked to an increased risk of atherosclerotic cardiovascular disease (ASCVD), including heart attacks and strokes. Roche’s newly cleared assay is expected to play a vital role in lipid metabolism analysis and ASCVD risk assessment when used alongside other lipoprotein tests. 

Advancing Precision in Cardiovascular Risk Assessment 

Unlike traditional assays that measure Lp(a) in mass units (mg/dL), Roche’s Tina-quant assay quantifies it based on particle number per litre of blood. This method is preferred within the scientific community because Lp(a) particles vary in size, making mass-based measurements less consistent. By providing molar unit measurements, the assay offers clinicians a more accurate tool to determine the actual number of Lp(a) particles, thereby improving risk assessment. 

The assay is performed via a routine blood draw, making it an accessible and straightforward diagnostic tool for clinicians and laboratory professionals. With this information, healthcare providers can make informed decisions regarding patient care and take necessary steps to mitigate cardiovascular risks. Identifying patients with elevated Lp(a) levels allows for early interventions, including lifestyle modifications and emerging therapeutic approaches aimed at reducing cardiovascular risk. 

Roche’s Continued Commitment to Innovation in Cardiology 

Roche has been actively advancing Lp(a) diagnostics. In May 2024, its Tina-quant Lp(a) RxDx assay received breakthrough device designation from the FDA. That assay is designed to help identify individuals who may benefit from emerging Lp(a)-lowering therapies, further supporting personalized cardiovascular care. 

The FDA’s clearance of the Tina-quant Lipoprotein (a) Gen.2 Molarity assay represents a major step forward in cardiovascular diagnostics, offering healthcare professionals improved precision in assessing cardiovascular disease risk and guiding patient management strategies. By expanding access to more accurate Lp(a) testing, Roche continues to contribute to the evolution of preventive cardiology, enabling better patient outcomes through early detection and targeted intervention. 

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