FDA Grants 510(k) Clearance to First Lp(a) Blood Test in Molar Units

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay, marking the first blood test cleared for the US market to measure lipoprotein (a) [Lp(a)] in molar units.¹

Announced by Roche, on January 29, 2025, the Tina-quant Lipoprotein (a) Gen.2 Molarity assay could aid the evaluation of lipid metabolism disorders and atherosclerotic cardiovascular disease (ASCVD) risk when used in conjunction with clinical assessment and other lipoprotein tests.

“Through no fault of our own, Lp(a) levels are determined at birth by genetics and thought to be unaffected by lifestyle changes, with approximately 20% of individuals living with elevated levels of this particle," Pam Taub, MD, a professor in the department of cardiovascular medicine at the UC San Diego School of Medicine, said in a statement.¹ "With the opportunity to now consistently and accurately measure Lp(a) in particle concentration units, and anticipated Lp(a)-lowering treatments coming to market, clinicians have an opportunity to help their patients understand and potentially lower their cardiovascular risk."

Recommendations from the National Lipid Association (NLA) advocate for all adults to measure Lp(a) at least once in a lifetime to determine cardiovascular risk. Lp(a) has emerged as a notable risk factor for ASCVD, with the ability to promote the spread of plaque in the artery walls, clot formation, and aortic valve calcification, but remains under-recognized across medicine.²

Lp(a) is variable in size without a defined molecular weight – scientific consensus has suggested Lp(a) should be measured in nanomoles per liter (nmol/L), rather than mass units (mg/dL). More than 90% of Lp(a) concentration is affected by variations in genetic Lp(a) levels, wherein factors, including diet and exercise, demonstrate no significant impact. Nearly 1 in 5 are affected by elevated Lp(a), particularly those of African descent and in women after menopause.³

Testing for Lp(a) could allow a more accurate determination of cardiovascular risk, with the potential to become a part of regular diagnostic testing and risk stratification based on this biomarker. The Tina-quant Lipoprotein (a) Gen.2 Molarity assay could allow for an assessment of ASCVD risk and lipid metabolism disorders in conjunction with other clinical and lipoprotein testing.¹

A routine blood draw will test for the number of Lp(a) particles per liter in a patient’s bloodstream (serum and plasma), providing clinicians with action items to reduce future ASCVD risk. Roche announced the blood test will be widely available on the company’s chemistry systems in the US (cobas® c analyzers).

In May 2024, the FDA granted Breakthrough Device Designation to the Roche Tina-quant Lp(a) RxDx assay, intended to select patients who may benefit from an innovative Lp(a)-lowering therapy.⁴ In their release, Roche confirmed its commitment to further advancement in preventive cardiology, emphasizing accurate Lp(a) testing using nmol/L to improve risk stratification and benefit the management of cardiovascular health.¹

"We are proud to support the NLA’s recommendation for Lp(a) testing, emphasizing accurate cardiovascular risk assessment with the first FDA-cleared test measuring in nmol/L units in the US," Brad Moore, president and CEO of Roche Diagnostics North America, said in a statement.¹ "Roche has an unrivaled ability to provide access to testing at scale and is committed to advancing innovation in preventive cardiology. This clearance comes in advance of disease-modifying therapies on the horizon expected to help clinicians use this biomarker to guide patients to improved cardiovascular health."

References

1. _{Roche receives FDA 510(k) clearance for the first blood test in the U.S. measuring LP(a) in molar units. Diagnostics. January 29, 2025. Accessed January 29, 2025. https://diagnostics.roche.com/us/en/news-listing/2025/roche-receives-fda-510k-clearance-for-the-first-blood-test-in-the-us-measuring-lpa-in-molar-units.html.}
2. _{Koschinsky ML, Bajaj A, Boffa MB, et al. A focused update to the 2019 NLA scientific statement on use of lipoprotein(a) in clinical practice. J Clin Lipidol. 2024;18(3):e308-e319. doi:10.1016/j.jacl.2024.03.001}
3. _{Kronenberg F, Mora S, Stroes ESG, et al. Frequent questions and responses on the 2022 lipoprotein(a) consensus statement of the European Atherosclerosis Society. Atherosclerosis. 2023;374:107-120. doi:10.1016/j.atherosclerosis.2023.04.012}
4. _{Roche granted FDA Breakthrough Device Designation For Blood Test measuring lp(a) - a key marker for hereditary cardiovascular risk. Diagnostics. May 22, 2024. Accessed January 29, 2025. https://diagnostics.roche.com/us/en/news-listing/2024/roche-granted-fda-breakthrough-device-designation-for-blood-test-measuring-lpa-a-key-marker-for-hereditary-cardiovascular-risk.html.}