The NGVB provides a number of tests to assist eligible investigators with meeting FDA requirements for clinical gene therapy.
Replication Competent Virus Testing. The NGVB offers biologic based assays for virus testing with a focus on testing for retroviral and lentiviral vectors.
PCR Testing. Quantitative PCR assays for vector copy number and viral detection are available, including testing for the VSV-G, GALV, Baboon Endogenous Virus, Cocal Virus, Amphotropic 4070A, and RD114 envelope DNA.
Insertion Site Analysis. PCR, next-generation sequencing, and bioinformatics analysis are available to eligible investigators
Pert Assay. Product Enhanced Reverse Transcriptase (PERT) Assay. PERT is a quantitative PCR based assay that uses the test material as a source of reverse transcriptase to convert a known quantity of mRNA into a DNA transcript.
p24 ELISA. Determining the concentration of p24 in a test article can serve to estimate the number of lentiviral vector particles or HIV-1 virions.
