Under the non-exclusive agreement, terms of which were not disclosed, the US contract research organisation (CRO) will use PGT’s tech to search many hundreds of genomes simultaneously for clinically significant allelic variations.
Prior to simultaneous analysis the cost of such large-scale testing was too high for the drug research sector according to PGT’s collaborations director Jason Mundin, who told Outsourcing-pharma.com about the firm’s approach.
“PGT’s technology can process several hundreds or even thousands of genomes simultaneously, in a single sequencing assay, while retaining ability to identify each individual genome during post-sequencing data analysis.”
Mundin explained that the ability to examine large numbers of genomes means biomarkers that are identified have excellent statistical significance and, perhaps more importantly, any false-positives can be easily detected.
“PGT can source high-value clinical sample sets, help in the identification of appropriate candidate regions and provide advanced bioinformatic analysis of data to produce strong correlations between genetic variants and disease phenotypes or drug response.”
He added that: “This approach enables the rapid identification of rare and common alleles that can collectively account for significant variation in treatment responses.”
“PGT has no plans at present to work with another CRO on similar terms and is focused on building on its already good relationship with Quintiles to demonstrate real clinical benefit to biopharma partners.”
Multi buster biopharma
Quintiles spokesman Jay Johnson agreed and suggested that: “Large-scale genomic testing offers significant benefits, but the costs have been too high for widespread use, especially in large clinical trials.
He cited reduced enrollment times, lower risk of adverse events and improved product differentiation among the key benefits and added that: “Biopharma’s future is “multi-buster” drugs targeted at specific patient populations based on their genetic makeup.
"This capability is crucial to successful drug development given that 70% of all Phase I-III trials include biomarkers in their protocols. In the near future, as DNA sequencing becomes standard in trials and clinical labs, we believe the technology will become a part of mainstream drug development."
Biomarkers in drug development
The deal with PGT is in keeping with comments Quintiles made earlier this year , when it told Outsourcing-pharma.com that greater use of biomarkers is needed to improve the efficiency of clinical research.