Assays for novel genetic biomarkers must be validated for use in late stage Clinical Trials. For example, the Illumina? VeraCode?
ADME Core Panel Kit on the BeadXpress? System is one of the available pharmacogenetic platforms used to genotype
human genomic DNA for variations in genes coding for proteins relevant to ADME. This method interrogates 184 biomarkers
in 34 ADME-related genes which cover more than 95% of the genetic content considered by the PharmaADME Working Group
to be important for pharmacogenetic drug studies including single nucleotide polymorphisms (SNPs), SNPs in close proximity,
insertions/deletions (indels), homologous regions, and copy number variants.
In this study, the ADME Core Panel Kit was validated as a category IV (identity) test per International Council on
Harmonization (ICH) Q2(R1) and current United States Pharmacopeia (cUSP) <1225> standards. The observed Call concordance
and Call Rate performance was consistent with that expected of a mature ADME genotyping platform. The test system had
additional performance characteristics that clearly distinguish it from its competitors and BioReliance is offering this validated
assay to support clinical phase 1-4 trials in regulated environment. In particular, the Kit excels in the difference in acceptable
mass of input genomic DNA relative to commercial competitor assays: DMET Plus Microarray and the iPLEX ADME PGx
panel. A broad dynamic range is useful in cases where limited amounts of genomic DNA are available, for example, in the case of
extraction from buccal swabs or FTA Cards
John Kolman leads the BioReliance Genomics business and supports biotech and pharmaceutical clients who require the custom validated
information-rich test technologies such as massively parallel sequencing and genotyping. These services are available in regulated laboratories to
clients in both the biologics manufacturing and clinical trial and diagnostics industries. He received his Ph.D. from Yale University and continued with
a Post-doctoral at the Salk Institute, eventually rising to Staff Scientist. His career has been motivated by the study of difficult biological questions
using new molecular approaches and a desire to ?get closer to the patient?.
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