The Heidelberg site is now authorized to perform integration site analysis on human samples under US federal regulations.
ProtaGene received Clinical Laboratory Improvement Amendments (CLIA) accreditation from the College of American Pathologists (CAP) for its Heidelberg, Germany, site. The accreditation allows the facility to perform integration site analysis (ISA) on human samples treated with lentivirus-based cell and gene therapy products.
The certification authorizes the laboratory to conduct testing on human specimens under US federal regulations. The accreditation followed an inspection of laboratory practices, systems, and personnel.
“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,” says Richard Gabriel, vice-president of research and development at ProtaGene, in a release.
The company provides ISA services ranging from sample receipt to report delivery. These services include sample quality control, library preparation, next-generation sequencing, bioinformatics analysis, and reporting.
By obtaining CLIA accreditation from CAP, the company aims to strengthen its role in providing safety analytical assessments for biopharmaceutical partners and healthcare organizations.
“Achieving CLIA accreditation highlights our role as a trusted biopharma partner, advancing safe therapies through reliable, high-quality analytics,” says Michael Stump, PhD, president at ProtaGene US, in a release.
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