ProtaGene, CGT Announces CAP & CLIA Approval for ISA Testing
HEIDELBERG, Germany, July 30, 2026 /PRNewswire/ -- ProtaGene is proud to announce that it has received Clinical Laboratory Improvement Amendments (CLIA) accreditation from the College of American Pathologists (CAP) for its Heidelberg site to perform Integration Site Analysis (ISA) on human samples treated with lentivirus-based cell and gene therapy products.
This certification confirms compliance with rigorous quality and regulatory standards. CAP accreditation for CLIA is a recognized benchmark for laboratory excellence, following a comprehensive inspection of practices, systems, and personnel. This accreditation authorizes testing on human specimens under U.S. federal regulations. "Reaching this milestone reflects our team's commitment to patient safety in cell and gene therapy, driven by adherence to the highest quality standards and the delivery of best-in-class, industry leading safety analyses.", said Richard Gabriel, Vice-President of Research and Development at ProtaGene.
We tailor our ISA services to meet the needs of each of our clients, from receiving samples to report delivery, including sample QC, library preparation, next-generation sequencing, bioinformatics analysis, and reporting.
We contribute to safer gene therapies by ultimately delivering:
- Data supporting safety assessments for cell and gene therapies involving viral vectors, non-viral vectors, or gene editing approaches
- Superior assay performance in a wide range of viral vectors
- De-risked regulatory approvals—the first ICH-validated ISA methodology
- Fast turnaround times
By earning the CLIA accreditation from CAP, ProtaGene strengthens its position as a leading provider of safety analytical assessments for biopharmaceutical partners and healthcare organizations worldwide. "Achieving CLIA accreditation highlights our role as a trusted biopharma partner, advancing safe therapies through reliable, high-quality analytics" added Michael Stump, PhD, President at ProtaGene US.
About ProtaGene
ProtaGene is a world-leading CRO partner for the biopharmaceutical and cell and gene therapy industries. ProtaGene provides the most advanced, integrated, and complete protein and gene analytic capabilities and packages, from discovery to product commercialization. A unique combination of protein- and gene-based analytical platforms makes ProtaGene the leading analytic service provider in biologics and cell and gene therapy development. The organization operates four sites in Europe and North America and works in advanced therapeutic platforms with leading biopharmaceutical and gene therapy companies worldwide. For additional information, visit www.protagene.com or follow us on LinkedIn.
SOURCE Protagene, US Inc
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