Roche Receives FDA 510(k) Clearance for First US Blood Test Measuring Lp(a) in Molar Units

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The US FDA has granted 510(k) clearance to the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay (Roche), making it the first FDA-cleared blood test in the US to measure lipoprotein (a) [Lp(a)] in molar units.¹

The Tina-quant Lipoprotein (a) Gen.2 Molarity assay is designed to aid in the evaluation of lipid metabolism disorders and atherosclerotic cardiovascular disease (ASCVD) risk when used alongside clinical assessment and other lipoprotein tests, Roche announced January 30, 2024, in a press release.¹

The National Lipid Association (NLA) recommends that all adults measure Lp(a) at least once in their lifetime to determine cardiovascular risk. Unlike other lipid measurements, Lp(a) varies in size and lacks a single molecular weight. Because of this, experts agree that Lp(a) should be measured in particle concentration (nmol/L) rather than in mass units (mg/dL), as conversion between the two is unreliable. Using nmol/L ensures that laboratory professionals and clinicians obtain more precise readings that reflect the actual number of Lp(a) particles present in the blood.^1,2

"We are proud to support the National Lipid Association's recommendation for Lp(a) testing, emphasizing accurate cardiovascular risk assessment with the first FDA-cleared test measuring in nmol/L units in the U.S.," Brad Moore, president and CEO of Roche Diagnostics North America, said in the press release. 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."¹

Lp(a) has gained attention as a significant but often under-recognized risk factor for cardiovascular disease due to its role in promoting plaque buildup in artery walls, clot formation, and aortic valve calcification. 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 people globally are affected by elevated Lp(a), particularly those of African descent and in women after menopause, according to the press release.¹

"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, professor at the UC San Diego School of Medicine for the Department of Cardiovascular Medicine, said in the statement. "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."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).¹

In May 2024, the FDA granted breakthrough device designation to another of the company’s Lp(a) assays (Tina-quant RxDx), for the identification of patients with history of ASCVD who may benefit from Lp(a)-lowering therapy currently in development.³

References:

1. Roche receives FDA 510(k) clearance for the first blood test in the U.S. measuring LP(a) in molar units. News release. Roche. January 29, 2025. Accessed February 5, 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. Roche granted FDA Breakthrough Device Designation For Blood Test measuring lp(a) - a key marker for hereditary cardiovascular risk. News release. Roche. May 22, 2024. Accessed February 5, 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