Shearing Extension Primer Tag Selection Ligation-Mediated PCR S-EPTS/LM PCR is GeneWerk’s most recommended assay for unbiased, genome-wide integration site analysis. Combined with sequencing and in-house bioinformatics analysis, S-EPTS/LM PCR delivers superior assay performance for the determination of integration site position and frequency of clonal contribution of your gene modified cells.

Superior assay performance

S-EPTS/LM PCR is becoming the new gold standard for integration site analysis. Built on the fundamentals of LAM-PCR, S-EPTS/LM-PCR overcomes many of the challenges of LAM-PCR such as restriction bias and slower turnaround time. Instead of initial linear PCR amplification and restriction digestion, the DNA is sheared and linkers with molecular barcodes for samples are added directly to the DNA fragments before exponential PCR steps.

The fast turnaround time of S-EPTS/LM PCR is particularly advantageous for time-sensitive applications such as CAR-T drug product assessments and malignancy characterizations. The assay is suitable for integration site analysis of all types of gene therapy vectors including lentiviral vectors, retroviral vectors, and transposons.

The first validated assay for ISA

S-EPTS/LM PCR has been validated for integration site analysis according to FDA, EMA and ICH guidelines. As the world’s first validated assay for ISA, the technique has already been successfully employed in several clinical trials and regulatory filings.

From sample preparation to bioinformatics analysis and reporting, we deliver an end-to-end service tailored to the unique needs of our clients.

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