June 18, 2026—The FDA has granted 510(k) clearance for Diazyme Laboratories’ Lipoprotein(a) Molarity assay. Clinical laboratories can use the assay for the quantitative determination of lipoprotein(a) levels in human serum and plasma, reported in molar units (nmol/L).
“For decades, variability in Lp(a) measurement due to apo(a) isoform heterogeneity has limited clinical comparability and interpretation across laboratories and platforms,” Chong Yuan, PhD, managing director of Diazyme, said in a release. “Our assay directly addresses this challenge by providing an isoform-independent measurement in molar units, standardized against IFCC-endorsed, MS-based RPM, enabling consistent and clinically meaningful quantification of lipoprotein(a) across diverse patient populations.” This is critical, he said, for improving risk stratification in cardiovascular disease, where Lp(a) is an established independent risk factor.