Genomic Solutions

We are your trusted partner in delivering quality clinical data and scientific problem-solving insights. With significant technical know-how, a skilled laboratory team and a broad range of framework assays covering multiple technology platforms, we have the ability to meet your testing needs.

• We have over 10 years of expertise in delivering target enumeration data, which is critical in CAR-T therapy
• Our assays have high sensitivity and low technical challenges, ensuring your data provides meaningful answers
• We have validated off-the-shelf solutions for VSVG and RCL
• We can quickly establish and validate product specific vector count number (VCN)
• We have established CAR-T tests for over a dozen transgene targets, and have authored one of the seminal papers in molecular detection of CAR-T in a clinical setting

Our Genomic application include:

• Tracking genomic alterations
• Transcriptome characterization and analysis
• Predictive/resistance solutions

Genomic solutions for biomarker detection

Navigate Genomic Solutions for AML and CAR-T

• GMP calibrator manufacturing, CAR enumeration, sensitive SNV detection, Viral safety monitoring, expression
• Myeloid-specific panels for monitoring mutations down to 0.2% VAF
• Custom solutions for product integrity evaluation

RNAi quantification by DDPCR

Non-CAP/CLIA duplex ddPCR assay utilizing stem-loop RT-qPCR for RNAi target and endogenous control gene for PK monitoring

1. Insensitive to 3′ RNA modification
2. Can be designed to detect 5′ deamination and other variations

Transgene Purity Assessment

Fit-for-purpose NGS method for adequate control of genomic integrity in support of gene therapy product

• Percent of DNA from intended sequence
• Percent of DNA from plasmid backbone
• SNV and indel in product as QC

Traditional variant detection NGS and Sanger sequencing are also available.