FDA clears first assay designed to measure lipoprotein(a) in nanomoles
Key takeaways:
- The FDA cleared a new lipoprotein assay designed to measure lipoprotein(a) in nmol/L.
- Measuring nmol/L rather than mg/dL may improve diagnostic accuracy during CV risk assessment.
Roche announced its next generation assay received FDA 510(k) clearance for the measurement of lipoprotein(a) for assessment of CV risk.
The assay (Tina-quant Gen.2) is the first Lp(a) assay available in the U.S. designed to measure Lp(a) in nmol/L, according to a company press release.
“Current FDA-cleared assays on the market measure Lp(a) in mass units — mg/dL,” Laura Parnas, PhD, lab value lead at Roche Diagnostics Medical & Scientific Affairs, told Healio. “As Lp(a) has no single, defined molecular weight and can vary in size, measuring the number of particles in a sample is preferred over measuring the mass of the particles in a sample. For this reason, the scientific community, including the National Lipid Association, agrees that Lp(a) levels should be measured in terms of the number of particles per liter of blood — nmol/L — rather than mass units.”
Parnas explained that by measuring Lp(a) nmol/L, measurements would represent the number of particles rather than any difference in the size of the particles.
The assay is designed to be used in conjunction with clinical evaluation and other lipoprotein tests to evaluated atherosclerotic CV risk in patients, according to the release.
As Healio previously reported, another of the company’s Lp(a) assays (Tina-quant RxDx) received FDA breakthrough device designation for the identification of patients with history of ASCVD who may benefit from Lp(a)-lowering therapy currently in development.
“Lp(a) has long been recognized as a critical marker for people at risk for CVD, with approximately one in five people worldwide living with elevated Lp(a) levels, putting them at increased risk for CVD including MI and stroke. But medicine has lacked the tools to tackle the problem,” Parnas told Healio. “Although Lp(a)-lowering therapies are in development, the current management of individuals with elevated Lp(a) are primarily targeted at reducing a patient’s traditional risk factors by encouraging lifestyle changes and managing the other conditions if present, such as high BP, high cholesterol, diabetes and weight.
“Lp(a) testing is therefore an important tool, enabling clinicians to make a more accurate assessment of CV risk,” Parnas said. “It is expected to become a part of regular diagnostic testing in the coming years, helping clinicians use this biomarker to guide patients to improved CV health.”
For more information:
Laura Parnas, PhD, can be reached at 9115 Hague Road, PO Box 50457, Indianapolis, IN 46250-0457.