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Roche, the parent company of Indianapolis-based Roche Diagnostics, said it received FDA clearance to sell a new test to help determine a patient’s risk of an often untested but common, usually genetic, risk factor for cardiovascular disease.
Roughly one in five people have elevated lipoprotein (a), or Lp(a), levels increasing their risk of heart attacks, strokes or other cardiac diseases. Lp(a)—often pronounced “L-P-Little-A”—like LDL-cholesterol can build up in the walls of your blood vessels, according to the Centers for Disease Control and Prevention. Elevated Lp(a) runs in families.
The Roche Diagnostic Tina-quant Lipoprotein (a) Gen.2 Molarity assay measures Lp(a) in something called molar units, which allows clinicians to better measure the number of particles, rather than mass units, to determine potential risk more accurately.
Roche said Lp(a) has long been recognized as a critical marker for people at risk of cardiovascular disease. However, the health care industry has lacked the tools to tackle the problem. The company said treatments are in development and Lp(a) testing is expected to become an important tool.
The company expects the test to be available in the second quarter of 2025. The test could be ordered by a physician along with other common bloodwork or as part of a cardiovascular risk assessment.
Swiss-based Roche, with its Roche Diagnostic North American headquarters in Indianapolis, said last week that the test is the first of its kind to receive FDA clearance in the United States.
“Since Lp(a) does not have a single, defined molecular weight and its size can differ, it is preferable to count the number of particles in a sample rather than measure their mass,” Laura Parnas, lab value lead of medical and scientific affairs for Roche Diagnostics, told the IBJ in a written response.
Parnas said the scientific community including the National Lipid Association agrees that Lp(a) levels should be quantified in terms of the number of particles per liter of blood (nmol/L, or nanomoles per liter) instead of mass units (mg/dL). “Utilizing molar units ensures that laboratory professionals and clinicians are measuring the number of particles, irrespective of their size variability,” she said.
Dr. James Trippi, cardiologist and lipidologist with Ascension St. Vincent, said he sees patients with lipid disorders and often measures Lp(a) levels.
“The good news is that there is more and more appreciation of this risk factor,” Trippi said.
Indianapolis-based Eli Lilly and Company announced in November that in a Phase 2 clinical trial, muvalaplin, an investigational small molecule medication, significantly reduced elevated Lp(a) levels in adults by up to 85% in the highest tested dosage.
Trippi said elevated Lp(a) levels is incredibly risky for people who have other risk factors such as very high cholesterol, smoking, high blood pressure and diabetes. “Lp(a) there adds another 60% to already high risk for heart disease,” he said. “So all these medicines are going to be aimed at people at high risk for developing cardiovascular disease because of existing risk factors and high Lp(a).”
He called the Tina-quant Lipoprotein (a) Gen.2 Molarity assay an important tool for cardiologists.
“We definitely want to do everything we can to prevent more heart problems and vascular problems,” Trippi said.
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