Diazyme Laboratories, Inc. Announces FDA 501(k) Clearance for MGUS for Kappa and Lambda Free Light Chain Assays
14th Jan 2026
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
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How Diazyme’s Kappa & Lambda Free Light Chain Assays Are Improving Diagnostic Confidence – A Testimonial from James DiPhilippo, Laboratory Director at New England Cancer Specialists
30th Apr 2025
Improving Oncology Diagnostics with Diazyme’s Free Light Chain Assays
In the fight against multiple myeloma and related plasma cell disorders, speed and accuracy in diagnostics are essential. For New England Cancer Specialists (NECS), one of the region’s leading oncology practices, bringing free light chain testing in-house was a critical step in improving patient care.
James DiPhilipp
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Dr. Alan Wu’s Testimonial on Diazyme’s Free Light Chain and ADA Assays
3rd Dec 2024
At Diazyme Laboratories, we take pride in offering innovative diagnostic solutions that empower healthcare professionals to make informed decisions. One such professional who has played a significant role in advancing diagnostic testing is Dr. Alan H.B. Wu, Ph.D. For nearly a decade, Dr. Wu has been a trusted and loyal customer, helping to shape the future of diagnostics by using Diazyme’s u
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