Roche receives FDA 510(k) clearance for the first blood test in the U.S. measuring Lp(a) in molar units

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Jan 29, 2025, 09:00 ET

Approximately one in five people worldwide has elevated Lp(a) levels, putting them at increased risk of cardiovascular diseases including myocardial infarction and stroke.¹
The Roche Diagnostics Tina-quant® Lipoprotein (a) Gen.2 Molarity assay is an in-vitro test measuring lipoprotein (a) in a person's bloodstream (serum and plasma), and will be broadly available on Roche's chemistry systems in the U.S.
By using molar units, laboratory professionals and clinicians can mitigate the influence of particle size differences on the measurement of Lp(a).

INDIANAPOLIS, Jan. 29, 2025 /PRNewswire/ -- Roche announced today that the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay has received 510(k) clearance from the United States Food and Drug Administration (FDA). This will be the first 510(k) cleared test of its kind available in the U.S. measuring lipoprotein (a), or Lp(a), in nanomoles per liter (nmol/L). The National Lipid Association (NLA) recommends all adults measure their Lp(a) – often referred to as L-P-Little-A – at least once in a lifetime to help assess cardiovascular risk.

Due to its unique properties, Lp(a) can vary in size and has no single, defined molecular weight. For this reason, there is a consensus in the scientific community that Lp(a) levels should be measured in terms of the number of particles per liter of blood (nmol/L), rather than mass units (mg/dL), and that any conversion between mass and molar units, is generally imprecise and unreliable. By using molar units, laboratory professionals and clinicians know the Lp(a) measurements reflect the number of particles rather than any difference in the size of the particles.

"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.," said Brad Moore, president and CEO of Roche Diagnostics North America. "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."

Lp(a) is emerging as an important, yet under-recognized, potential risk factor for cardiovascular disease due to its ability to promote the development of plaques within artery walls, clot formation and aortic valve calcification. More than 90% of the Lp(a) level is influenced by variations in the genes controlling the Lp(a) particle production,² in which lifestyle interventions such as diet and exercise have no significant impact. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease (ASCVD) risk when used in conjunction with clinical evaluation and other lipoprotein tests.^3,4

"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," said Pam Taub, M.D., FACC, FASPC, professor at the UC San Diego School of Medicine for the Department of Cardiovascular Medicine. "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."

The development of the Tina-quant Lipoprotein (a) Gen.2 Molarity assay aligns with Roche's commitment to lead with science in order to develop transformational solutions that help improve patient outcomes and simplify lab operations. In addition to addressing traditional modifiable risk factors, healthcare professionals increasingly rely on biomarkers like Lp(a) and high sensitive-CRP to enhance cardiovascular risk stratification and provide more comprehensive assessments. Roche's leadership in this field highlights its commitment to advancing innovation in preventive cardiology, emphasizing the importance of accurate Lp(a) testing in nmol/L to refine risk prediction and improve cardiovascular health management.

About Lp(a)

Globally, as many as one in five people has elevated Lp(a),¹ in which lifestyle interventions such as diet and exercise have no significant impact. While Lp(a) levels can be influenced by non-genetic factors including menopause, kidney and liver diseases, and hyperthyroidism, they are predominantly (>90%) determined by genetic variations in the LPA gene.² Raised Lp(a) is particularly prevalent among people of African descent and can increase in women following menopause.^5,6

High levels of Lp(a) have been shown to promote the buildup of lipids in artery walls creating plaques, causing the formation of clots and increasing aortic valve calcification, which have all been associated with an increased risk of cardiovascular (CV) events.² Lp(a) testing is therefore an important tool for clinicians, enabling them to make a more accurate assessment of CV risk, and it is expected to become a part of regular diagnostic testing in the coming years.

Professional bodies around the world, including the National Lipid Association, Canadian Cardiovascular Society, European Atherosclerosis Society, European Society of Cardiology and the Beijing Heart Society, have recommended that Lp(a) measurement should be considered at least once in every adult person's life.

About the Tina-quant Lipoprotein (a) Gen.2 Molarity assay

The FDA granted 510(k) clearance to the Tina-quant Lipoprotein (a) Gen.2 Molarity assay, which is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk, when used in conjunction with clinical evaluation and other lipoprotein tests.

A lipoprotein (a) test involves a routine blood draw, during which a small sample of blood is used for measurement. This test measures the number of Lp(a) particles per liter in a person's bloodstream (serum and plasma), which will help clinicians take actionable steps to reduce atherosclerotic cardiovascular disease risk in the future. It will be broadly available on cobas® c analyzers.

In May 2024, as part of a separate FDA submission, the Roche Tina-quant Lp(a) RxDx assay, which is intended to support the selection of patients who may benefit from an innovative Lp(a)-lowering therapy, received a Breakthrough Device Designation from the FDA. This is different from the Tina-quant Lipoprotein (a) Gen.2 Molarity assay cleared today.

About Roche

Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
1. Tsimikas S and Marcovina S, Ancestry, Lipoprotein(a), and Cardiovascular Risk Thresholds: JACC Review Topic of the Week, J Am Coll Cardiol. 2022 Aug, 80 (9) 934–946
2. Kronenberg F. et al, Lipoprotein(a) in atherosclerotic cardiovascular disease and aortic stenosis: a European Atherosclerosis Society consensus statement, European Heart Journal, Volume 43, Issue 39, 14 October 2022, Pages 3925–3946
3. Koschinsky ML et al. A focused update to the 2019 NLA scientific statement on use of lipoprotein(a) in clinical practice. J Clin Lipidol. 2024 May-Jun;18(3):e308-e319. doi: 10.1016/j.jacl.2024.03.001.
4. Arnett DK et al. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: Executive Summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019 Sep 10;140(11):e563-e595. doi: 10.1161/CIR.0000000000000677.
5. Simony SB, Mortensen MB, Langsted A, Afzal S, Kamstrup PR, Nordestgaard BG. Sex differences of lipoprotein(a) levels and associated risk of morbidity and mortality by age: The Copenhagen General Population Study. Atherosclerosis. 2022 Aug;355:76-82. doi: 10.1016/j.atherosclerosis.2022.06.1023. Epub 2022 Jun 27. PMID: 35803767.
6. Mehta A, Jain V, Saeed A, Saseen JJ, Gulati M, Ballantyne CM, Virani SS. Lipoprotein(a) and ethnicities. Atherosclerosis. 2022 May;349:42-52. doi: 10.1016/j.atherosclerosis.2022.04.005. PMID: 35606075.