Goal is to create a new NGS-based tool and demonstrate benefits of standardized testing.
Life Technologies, Oxford Biomedical Research Centre (BRC), AstraZeneca, and Ortho Biotech Oncology Research & Development (ORD) have formed a consortium to develop a test to identify therapy options for cancer patients. Separately, Cancer Research UK is implementing a complementary initiative to demonstrate the benefit of routinely testing tumor samples as a standardized, cost-effective process.
The Life Tech-led group, which made a successful bid for a Technology Strategy Board grant, also aims to make clinical trial enrollment less of a trial-and-error process. It will create and validate a new test based on Life Technologies’ Ion Torrent Personal Genome Machine™ (PGM), a next-generation sequencing platform. The semi-conductor based PGM was selected for its ease of use, speed, accuracy, and economic pricing. The new test will include a report on nine known genetic markers at a price that is affordable within the National Health Service.
Beginning in 2012, the Oxford BRC will use this PGM-based test to conduct a 1,500-patient prospective clinical trial that will measure and report on an expanded panel of 150 genes. The genes will be selected with input from pharmaceutical companies as genes of interest for potential new drug targets or markers for efficacy of existing drugs or those under development.
Through review of these study results, physicians may be able to identify alternative care options for their patients, and be able to recommend suitable drug trials taking place in the Oxford system. “The current system for clinical trial enrollment is grossly inefficient,” remarks Sir John Bell, Regius professor of medicine at University of Oxford. “The onus is on individual patients and their doctors to identify and apply for trials. If a patient is not eligible for one trial, they must start anew looking for another.”
In contrast, treating physicians who have patients participating in the clinical study at Oxford will receive a report based on genetic analysis, outlining which of the trials ongoing at Oxford could be a suitable match for each of their patients in the program.
“We’re trying to evolve a new model for both cancer treatment and cancer clinical trials,” comments James Peach, director of stratified medicines at Cancer Research UK, “in which patients are quickly moved into appropriate trials based on their individual genetics.”
The Cancer Research UK program will be a multiyear investment that will begin with a pilot phase testing 9,000 patients’ DNA for cancer markers in nine known cancer genes. The new multigene NGS test developed by Life Technologies will be made available to Cancer Research UK stratified medicine laboratories in early 2012 for comparison with existing testing methodologies.