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LAM-PCR & Target-NGS Golden Standard Integration Site Analysis Service

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Creative Biolabs provides Ligation-Mediated Polymerase Chain Reaction (LAM-PCR) & Target-NGS Integration Site Analysis Services to support precise vector integration profiling and clonal safety assessment for gene-modified therapies, including in vivo CAR programs. This service addresses challenges such as unclear integration patterns, limited clonal tracking resolution, insertion-associated oncogenic risk, and low-frequency integration detection. By combining LAM-PCR with next-generation sequencing (NGS) and advanced bioinformatics analysis, Creative Biolabs enables genome-wide mapping of integration sites, quantification of clonal abundance, and evaluation of genotoxic risk to support safer and more predictable therapeutic design.

Introduction

LAM-PCR is a well-established method for capturing unknown genomic sequences adjacent to vector integration sites through linear amplification and adaptor ligation. Combined with NGS, it enables high-throughput mapping of integration events at single-base resolution. The literature demonstrates its broad application in retroviral and lentiviral gene therapy safety studies, particularly for clonal expansion monitoring and insertional mutagenesis risk evaluation. Modern Target-NGS enhancements further reduce amplification bias and improve genome coverage, making this combined strategy a gold-standard approach for integration site profiling.

Our Service

Creative Biolabs provides comprehensive integration site mapping for gene-modified therapies like CAR-T. Our service delivers genome-wide vector identification with high sensitivity. We accurately locate integration hotspots and analyze proximity to nearby genes. This allows us to screen for insertion-associated oncogenic risks early. These advanced capabilities ensure thorough safety assessments for your modified cell products.

We also offer clonal abundance quantification and longitudinal tracking over time. Our team generates customized bioinformatics reports tailored for regulatory-grade documentation. These precise insights directly support your safety assessments and regulatory submissions. Ultimately, our end-to-end solutions ensure reliable, long-term monitoring of clonal architecture.

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What We Can Offer

Analysis of LAM-PCR & Target-NGS Golden Standard Integration Site Analysis. (Creative Biolabs Original)

Creative Biolabs combines diverse advanced analytical tools for full detection and analysis of vector integration sites. It uses LAM-PCR to amplify vector-genome junctions, targeted NGS to identify integration sites in high throughput, high-resolution pipelines to map locations on chromosomes, algorithms to calculate clonal abundance, tools to find integration hotspots, and bioinformatics platforms to assess insertional risks and generate professional analysis reports.

Our Workflow

Clients shall provide gene-modified cell samples, viral or non-viral vector construct information, and experimental metadata covering sampling time points, dosing parameters, and in vitro or in vivo experimental conditions.

Workflow of LAM-PCR & Target-NGS Golden Standard Integration Site Analysis. (Creative Biolabs Original)

Clients will receive a complete integration site mapping report, datasets of clonal abundance and expansion profiles, and genomic annotation of insertion sites paired with a consolidated risk assessment summary.

Benefits

Oncogenic proximity and insertional risk assessment with genome-wide annotation and functional interpretation.
Scalable workflow adaptable from small pilot projects to large cohort studies with high-throughput sequencing capacity.
Robust bioinformatics pipeline ensuring reproducibility, standardized reporting, and regulatory-oriented data output.
High-sensitivity detection of low-frequency integration events and rare clonal populations for early safety signal identification.
Comprehensive clonal expansion analysis with longitudinal tracking capability across multiple time points.

FAQs

Q: What is the advantage of combining LAM-PCR with NGS?

A: LAM-PCR selectively enriches unknown vector-genome junctions with single-nucleotide precision, while NGS delivers high-throughput sequencing. Combining them enables highly sensitive, unbiased, and genome-wide mapping of insertion sites.

Q: Can this service detect low-frequency clones?

A: Yes. By combining optimized target enrichment with deep NGS sequencing, this platform achieves exceptional sensitivity, allowing it to detect rare or minor clonal populations that conventional methods miss.

Q: Is this suitable for CAR-T safety evaluation?

A: Absolutely. This methodology is a standard regulatory expectation for CAR-T therapies, used to assess genomic integration behaviors, verify vector safety, and monitor potential clonal expansion risks over time.

Q: What type of integration risks can be identified?

A: It identifies critical risks including vector insertions near proto-oncogenes, disruption of regulatory elements, and abnormal clonal dominance patterns that could signal insertional mutagenesis or potential genotoxicity.

Partner with Us

Creative Biolabs provides LAM-PCR and Target-NGS integration site analysis services. Our platform supports gene therapy safety evaluations and long-term clonal tracking. We deliver regulatory-grade genomic characterization with high sensitivity. This advanced system offers deep insights into vector behavior across diverse gene-modified cell products. It accurately monitors clonal dynamics over time to ensure patient safety. Please contact our team today for a detailed project discussion, expert technical consultation, or customized study design.

All products and services are For Research Use Only and CANNOT be used in the treatment or diagnosis of disease.