Genomic safety is essential for gene therapy success and regulatory approval, as well as commercial testing. ProtaGene offers a comprehensive suite of analytical platforms to address this need, including solutions for detecting vector integration sites (IS), on-/off-target events and molecular bioanalytics.

Our S-EPTS/LM-PCR and TES methods are used for detecting integration sites. S-EPTS is effective and validated for integrating vectors like lentiviruses, while TES captures the entire vector sequence, making it ideal for vectors prone to rearrangements like AAV. A TES-based workflow is also used to verify CRISPR-Cas9 off-target edits with high sensitivity.
ProtaGene also provides additional services like vector copy number quantification, transgene expression among others to support various gene therapy modalities from research to clinical trials and ensure robust safety assessments. With a recent CLIA accreditation, ProtaGene is now able to support commercial testing.