Saturday, June 22, 2024

Breakthrough in Cardiovascular Diseases: FDA Approves Roche’s New Lp(a) Blood Test for Cardiovascular Risk

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Roche has announced that its Tina-quant® lipoprotein (a) [Lp(a)] RxDx blood test for cardiovascular diseases has received Breakthrough Device Designation from the Food and Drug Administration (FDA). This innovative blood test measures Lp(a), a critical marker for hereditary cardiovascular risk, and is expected to improve the management of cardiovascular diseases significantly. Elevated levels of Lp(a) are associated with an increased risk of cardiovascular events such as myocardial infarction and stroke. The FDA’s Breakthrough Device Designation aims to expedite the development and review of medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

This new test, developed in collaboration with Amgen, will be available on Roche’s extensive network of over 90,000 serum work area systems worldwide. The test’s availability on such a broad platform ensures that healthcare providers globally can access this advanced diagnostic tool. The widespread implementation of the Tina-quant® Lp(a) RxDx assay will enable more standardized and accurate measurement of Lp(a) levels, which is crucial for identifying patients at risk and tailoring appropriate therapeutic interventions.

The collaboration between Roche and Amgen combines Amgen’s deep expertise in cardiovascular disease with Roche’s leading diagnostic capabilities. This partnership underscores the importance of collaborative efforts in addressing significant health challenges and advancing patient care. By leveraging their respective strengths, the two companies aim to enhance the detection and management of cardiovascular risk, ultimately improving patient outcomes.

New Blood Test Promises More Accurate Risk Assessment and Hope for Cardiovascular Disease Management

The introduction of this assay represents a significant advancement in the field of cardiovascular diagnostics. Current lab tests for Lp(a) levels often suffer from inconsistencies and may not accurately reflect a patient’s cardiovascular risk. The Tina-quant® Lp(a) RxDx assay addresses these limitations by providing a more reliable and precise measurement of Lp(a) in nanomoles per liter (nmol/L). This level of accuracy is essential for clinicians to make informed decisions regarding patient care and treatment plans.

In addition to its diagnostic precision, the Tina-quant® Lp(a) RxDx assay will play a pivotal role in ongoing research and development of new therapies aimed at lowering elevated Lp(a) levels. Identifying patients who could benefit from these innovative treatments is critical for advancing cardiovascular medicine and offering new hope to those with hereditary risk factors. The test’s integration into routine clinical practice will facilitate better patient monitoring and management, contributing to improved long-term health outcomes.

Overall, the FDA’s Breakthrough Device Designation for the Tina-quant® Lp(a) RxDx assay highlights the test’s potential to transform cardiovascular risk assessment and management. Roche’s commitment to innovation and collaboration with Amgen reflects its dedication to addressing unmet medical needs and enhancing global healthcare delivery. With the widespread availability of this test, healthcare providers will be better equipped to identify at-risk patients and implement timely, effective interventions to mitigate cardiovascular risks.

Cardiovascular Disease

New Test Targets Under-recognized Lp(a) for Improved Cardiovascular Disease Management

Approximately one in five people globally have elevated Lp(a) levels, which increases their risk of cardiovascular diseases, including myocardial infarction and stroke. Despite this, Lp(a) is often an under-recognized risk factor. “While modern lifestyles contribute significantly to cardiovascular risk, 30% of mortality associated with cardiovascular disease occurs in individuals without modifiable risk factors,” said Matt Sause, CEO of Roche Diagnostics. Elevated Lp(a) is a crucial marker that medicine has yet to adequately address.

Through collaboration with Amgen, Roche aims to address the low testing rates and inconsistencies in existing Lp(a) lab tests. Jay Bradner, M.D., Executive Vice President of Research and Development and Chief Scientific Officer at Amgen, stated, “By combining Amgen’s expertise in cardiovascular disease with Roche’s diagnostic capabilities, we can accelerate access to standardized testing and equip patients and healthcare providers with essential information to better understand cardiovascular risk.”

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From Diagnosis to Treatment: Roche’s Test Integrates into Cardiovascular Disease Management

The new Tina-quant® test will measure Lp(a) levels in nanomoles per liter (nmol/L), a more accurate method than the current tests that measure in milligrams per liter (mg/L). This assay is expected to support selecting patients who may benefit from innovative Lp(a)-lowering therapies currently in development. Once approved, this test will be a part of Roche’s broader portfolio of cardiovascular disease tests, providing healthcare professionals with tools to make informed treatment decisions.

Professional bodies worldwide, including the Association and the European Society of Cardiology, recommend measuring Lp(a) at least once in every adult’s life. Elevated Lp(a) levels, predominantly determined by genetic factors, are a significant concern, especially among women and people of African descent. These raised levels can lead to the buildup of lipids in artery walls, increasing the risk of cardiovascular events.

Roche has grown into the world’s largest biotechnology company and a global leader in in-vitro diagnostics. The company’s commitment to scientific excellence and personalized healthcare has transformed how healthcare is delivered, aiming to improve and save lives worldwide. Roche’s collaboration with Amgen and the development of the Tina-quant® Lp(a) RxDx assay highlight its ongoing efforts to innovate and provide solutions to critical health challenges.


Resource: Roche, May 22, 2024

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