Pharma Focus America

Roche Receives FDA Breakthrough Device Designation for Blood Test Evaluating Lp(a) as Key Indicator of Hereditary Cardiovascular Risk

Thursday, May 23, 2024

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Tina-quant® lipoprotein Lp(a) RxDx assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). This designation aims to identify patients who might benefit from innovative Lp(a)-lowering therapy currently in the works. Lp(a) is increasingly recognized as a significant yet often overlooked risk factor for cardiovascular disease, a critical public health concern.

"Despite modern lifestyle factors contributing significantly, up to 30% of cardiovascular disease-related deaths occur in individuals without modifiable risk factors," remarked Matt Sause, CEO of Roche Diagnostics. "Lp(a) stands as a crucial marker for individuals at risk of cardiovascular disease, but the medical field has lacked comprehensive solutions to address it. Through our collaboration with Amgen, Roche aims to establish elevated Lp(a) as an actionable biomarker."

"Lp(a) testing rates remain notably low, and existing lab tests may not consistently or accurately measure Lp(a) levels," noted Jay Bradner, M.D., Executive Vice President of Research and Development and Chief Scientific Officer at Amgen. "By combining Amgen's extensive experience in cardiovascular disease with Roche's diagnostic expertise, we can expedite access to more standardized testing, empowering more patients and healthcare providers with vital information to assess cardiovascular disease risk."

Upon approval, the new Tina-quant® test is anticipated to be accessible to aid in selecting patients who could benefit from an innovative Lp(a)-lowering therapy.

Globally, as many as one in five individuals have elevated Lp(a), where lifestyle changes such as diet and exercise have limited impact. While various factors such as menopause, kidney and liver disease, and hyperthyroidism can influence Lp(a) levels, they are primarily (>90%) determined by genetic variations in the LPA gene. Elevated Lp(a) is particularly prevalent among women and individuals of African descent.

High levels of Lp(a) have been linked to lipid accumulation in artery walls, leading to plaque development and an increased risk of cardiovascular events. Lp(a) testing is thus crucial for clinicians to accurately assess cardiovascular risk and is expected to become a standard part of diagnostic testing in the future. Several professional bodies worldwide recommend considering Lp(a) measurement at least once in every adult's life.

Since Lp(a) lacks a defined molecular weight, the scientific community suggests measuring Lp(a) levels in terms of the number of molecules per liter of blood (nmol/L), contrasting with available tests that measure Lp(a) molecular weight in the blood (mg/L).

The FDA has granted Breakthrough Device Designation to the Tina-quant Lp(a) RxDx assay for identifying patients with elevated Lp(a) and a history of atherosclerotic disease for treatment with an Lp(a)-lowering drug. This test, conducted through a routine blood draw, measures the number of Lp(a) molecules per liter in a person's bloodstream, laying the groundwork for Lp(a) to serve as an actionable biomarker in the future. Upon approval, it will be available on selected cobas® platforms.

Currently, there is no FDA-authorized Lp(a) assay measuring Lp(a) in nmol/L available in the US. This assay will complement Roche's broader portfolio of cardiovascular disease tests, enabling healthcare professionals to make informed decisions and granting patients access to new and innovative treatments.

The Breakthrough Devices Program is a voluntary initiative for certain medical devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It aims to expedite the development and review of these medical devices.



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