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POWAY, CA – June 17, 2026 – Diazyme Laboratories, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Diazyme Lipoprotein(a) Molarity Assay. This clearance enables clinical laboratories to use the assay for the quantitative determination of lipoprotein-Lp(a) levels in human serum and plasma, reported in molar units (nmol/L).

“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.

 “Our assay directly addresses this challenge by providing an isoform-independent measurement in molar units, standardized against IFCC-endorsed MS-based RMP, enabling consistent and clinically meaningful quantification of Lipoprotein(a) across diverse patient populations. This is critical for improving risk stratification in cardiovascular disease, where Lp(a) is an established independent risk factor,” said Chong Yuan, Ph.D., Managing Director of Diazyme Laboratories, Inc.

“We believe this clearance will help accelerate broader clinical adoption of standardized Lp(a) testing and support clinicians in identifying high-risk patients who may otherwise go undetected using conventional mass-based or isoform-sensitive methods.”

About Diazyme Laboratories, Inc.

Diazyme Laboratories, Inc. is located in Poway, California. Diazyme uses its proprietary enzyme and immunoassay technologies to develop diagnostic test reagents run on automated chemistry analyzers and chemiluminescence instruments in user-friendly formats. Diazyme is a cGMP and ISO 13485 certified medical device manufacturer. Information regarding Diazyme’s technology and products can be found on its website at www.diazyme.com.

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