Diazyme Laboratories, Inc. Announces FDA 510(k) Clearance for Lipoprotein(a) Molarity Assay

This section is Partnership Content suppliedThe content in this section is supplied by GlobeNewswire for the purposes of distributing press releases on behalf of its clients. Postmedia has not reviewed the content. by GlobeNewswire Article contentPOWAY, Calif.

, June 18, 2026 (GLOBE NEWSWIRE) — 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).Sign In or Create an AccountEmail AddressContinueor View more offersArticle content“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.Article contentWe apologize, but this video has failed to load.Try refreshing your browser, ortap here to see other videos from our team.

Article contentArticle content“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. 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.Article contentTop StoriesGet the latest headlines, breaking news and columns.There was an error, please provide a valid email address.

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Please try againInterested in more newsletters? Browse here.Article content“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.”

Article contentAbout Diazyme Laboratories, Inc.Article contentDiazyme 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.Article contentFor Further Information Contact:Article contentSalesTel: 858-455-4768Email: Sales@Diazyme.

comSupportEmail: Support@Diazyme.comArticle contentArticle contentArticle contentArticle contentArticle contentArticle contentAdvertisement 1This advertisement has not loaded yet.Trending Posthaste: What Canada's 'demographic recession' means for the economy News CRA will clip your wings if you take a personal ride in the corporate jet Personal Finance Advertisement 1Story continues belowThis advertisement has not loaded yet, but your article continues below.

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by GlobeNewswire This section is Partnership Content suppliedThe content in this section is supplied by GlobeNewswire for the purposes of distributing press releases on behalf of its clients. Postmedia has not reviewed the content. by GlobeNewswire This section is Partnership Content suppliedThe content in this section is supplied by GlobeNewswire for the purposes of distributing press releases on behalf of its clients.

Postmedia has not reviewed the content. by