News & Events

Join Cincinnati Children's Hospital Medical Center at ADLM 2026 for a poster presentation showcasing the clinical validation of the Diazyme MMP-7 assay as a non-invasive screening tool to help rule out biliary atresia in newborns and infants. The presentation will highlight the assay's analytical performance and its potential to support efficient, cost-effective screening in clinical laboratories. …

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). &ldquo …

POWAY, CA – June 1, 2026 – Diazyme Laboratories, Inc. announced today that it has acquired the business of Carolina Liquid Chemistries Corporation (CLC). CLC is an FDA registered manufacturer, and value-added reseller of chemistry systems and reagents. Founded in 1994 and headquartered in Greensboro, North Carolina, CLC's business will be integrated into Diazyme’s operations. &ld …

Abbott recently hosted a webinar exploring the clinical role of kappa and lambda free light chain testing in the diagnosis and monitoring of plasma cell disorders such as multiple myeloma. Key points include the use of the kappa/lambda ratio to identify abnormal monoclonal protein production and how free light chain assays complement serum protein electrophoresis and immunofixation to support more …

SAN DIEGO, CA - January 14, 2026 - Diazyme Laboratories, Inc. announces receiving 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the evaluation of monoclonal gammopathy of undetermined significance (MGUS) for Diazyme’s Kappa and Lambda Free Light Chain Assays. “FDA 510(k) clearance of added indication to our free light chain kappa and lambda assays demonstra …