July 2026—The FDA has granted 510(k) clearance for Diazyme Laboratories’ Lipoprotein(a) Molarity assay for use in the quantitative determination of Lp(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 clinicaly 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.
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