The assay measures lipoprotein(a) levels in molar units to improve cardiovascular risk assessment and standardization across laboratories.
The Food and Drug Administration (FDA) has granted 510(k) clearance for the Diazyme Lipoprotein(a) Molarity Assay, Diazyme Laboratories announced. The clearance enables clinical laboratories to use the assay for the quantitative determination of lipoprotein(a) (Lp(a)) levels in human serum and plasma.
Results from the assay are reported in molar units (nmol/L). The test is designed to provide an isoform-independent measurement, addressing variability in Lp(a) measurements that has historically limited clinical comparability and interpretation across different laboratory platforms.
“FDA 510(k) clearance of our Lipoprotein(a) Molarity Assay represents a major step forward in cardiovascular risk assessment. For decades, variability in Lp(a) measurement due to apo(a) isoform heterogeneity has limited clinical comparability and interpretation across laboratories and platforms,” says Chong Yuan, PhD, managing director of Diazyme Laboratories, Inc., in a release.
Lp(a) is an established independent risk factor for cardiovascular disease. According to the company, the assay provides a measurement that allows for consistent quantification of the biomarker across diverse patient populations. This may help clinicians identify high-risk patients who could go undetected using conventional mass-based or isoform-sensitive methods.
“Our assay directly addresses this challenge by providing an isoform-independent measurement in molar units, enabling consistent and clinically meaningful quantification of Lipoprotein(a) across diverse patient populations,” says Yuan in a release.
The company suggests the clearance will help accelerate the clinical adoption of standardized Lp(a) testing and support clinicians in identifying high-risk patients.
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