Certification underscores the company's operational maturity and readiness to deliver clinical-grade genomic sequencing solutions under IVDR
SAN DIEGO, June 17, 2026 — Element Biosciences Inc. today announced that the company has achieved ISO 13485 certification for its Quality Management System (QMS). The certification marks a significant milestone in Element Biosciences’ evolution beyond research sequencing and positions the company for the anticipated launch of AVITI Dx™ later this year.
ISO 13485 is the internationally recognized quality management standard for medical devices and IVD products. Achieving certification requires organizations to demonstrate that every facet of their design, development, manufacturing, and post-market surveillance processes meets rigorous regulatory standards. For Element, the certification reflects a company-wide commitment to operational excellence and the quality infrastructure required to support regulatory requirements, including compliance with the EU In Vitro Diagnostic Regulation (IVDR).
“Receiving ISO 13485 certification is a testament to the discipline and dedication of the entire Element team,” said Jeff Labbadia, senior vice president of operations at Element Biosciences. “This is not simply a checkbox, but a validation of the quality standards Element has upheld since its inception. ISO 13485 certification is the formal recognition of that commitment, and it sets the stage for AVITI Dx and our ambition to make high-accuracy sequencing the standard of care in diagnostics.”
AVITI Dx is Element Biosciences’ forthcoming Class A IVDR sequencing platform, designed to bring the accuracy, throughput, and workflow advantages of the AVITI system to clinical laboratories. The company expects to announce AVITI Dx availability in late 2026 in select countries. ISO 13485 certification is a critical prerequisite for IVD regulatory filings across the EU and many international markets, and reinforces Element Biosciences’ readiness to engage with clinical laboratory customers and partners that are advancing sequencing-based diagnostics, including Element’s ongoing IVD co-development work with Revvity for newborn screening.
About Element Biosciences, Inc.
Element Biosciences is pioneering the technologies that enable a deeper understanding of life. Our platforms capture biology in its full dimensionality—spanning genetic, molecular, and cellular insights—to unlock richer data and drive scientific breakthroughs. From foundational research, to the discoveries that help shape diagnostic and therapeutic development, Element empowers scientists to advance the frontiers of biology and impact every corner of human health. To learn more about Element, please visit www.elementbiosciences.com and follow us on LinkedIn, X (Twitter), and Facebook.
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