PAISLEY, U.K., June 22, 2011 /PRNewswire/ --
Programme aims to demonstrate clinical and economic benefit of DNA sequencing such as: - standardised tests for fast, comprehensive decision making, and - increased pharmaceutical investment in UK-based clinical trials
Life Technologies Corporation [http://www.lifetech.com ] today announced that the company has led a successful consortium bid for a Technology Strategy Board grant, in partnership with the Oxford NIHR Biomedical Research Centre, AstraZeneca, and Ortho Biotech Oncology Research & Development unit of Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (ORD). The grant will fund development of a commercial multi-gene next generation sequencing test that will provide comprehensive molecular profiles of tumours in order to identify therapy options. Development of this test will improve the consistency and elevate the standards of cancer care as well as stimulate UK economic growth and job creation.
"Cancer patients are fighting a progressive disease, and they need answers fast. Incomplete or incorrect diagnostic information can lead them down unproductive therapy paths," said Sir John Bell, Regius Professor of Medicine at University of Oxford. "New DNA sequencing technology can improve the speed and accuracy of cancer care decision making. This consortium will help pave the way."
New panels expected to have broad global impact on cancer care and bring economic benefit to Great Britain
The programme is expected to have significant economic benefit on several levels. Using novel next generation sequencing (NGS) and informatics, the genomic test will be commercially available to a global market, and the UK will share in the economic proceeds. Genomic testing infrastructure, including next gen sequencing, will attract additional pharmaceutical clinical trial investment in the UK, a major source of international investment. Pharma companies AstraZeneca and ORD are supporting the programme because they recognise its potential for efficient clinical trials and new research insights. Meanwhile, the National Health Service (NHS) can save money through effective allocation of treatments. Market analysis indicates that even if only five per cent of cancer patients avoided one round of ineffective therapy, more than 375 million pounds Sterling (US$560) would be saved.
In addition, the programme also aims to make clinical trial enrollment less of a trial-and-error process. Today, patients learn about clinical trial opportunities through their physician or online resources. They may qualify for a trial based on a number of factors including specific genetic markers or profile. With standardised genomic testing in place, one diagnostic test will enable a physician to recommend several trials that may be suitable for their patient. At the same time, pharma companies should be able to start their studies more quickly, and will be able to review the genetic profile of patient cohorts to better understand the genetic factors associated with favorable or unfavorable drug response. A new clinical trial model could emerge.
Demonstrating medical benefit of broad genomic sequencing, while creating an efficient new model for clinical trials
Britain's largest cancer charity, Cancer Research UK is implementing a separate but complementary programme which aims to demonstrate the benefit of routinely testing tumour samples as a standardised, cost-effective process. This program is a multi-year investment that will begin with a pilot phase testing 9,000 patients' DNA for cancer markers in nine known cancer genes.
"Research into cancer genetics has led to an understanding of what gene tests can help a doctor target the right treatment for the right patient," said James Peach, Director of Stratified Medicines at Cancer Research UK. "Cancer Research UK recognises the huge potential for targeted treatment in the future of cancer care, but we need to ensure the NHS can deliver the tests. We believe that the best way for this to happen is if we can demonstrate a consolidated, quality assured sample collection and testing network covering the main biomarkers for existing and future therapies. By proving that this can work in the NHS, we can make sure that all doctors can access the right tests."
The new multi-gene 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. The Life Technologies programme fits with the Cancer Research UK Stratified Medicine by developing the test, while Cancer Research UK Stratified Medicine will demonstrate the operational model to deliver these tests in the NHS.
1,500 patient program at Oxford will report expanded panel of 150 genes selected by researchers and pharmaceutical partners
Beginning in 2012, the Oxford BRC will be conducting a 1,500 patient prospective clinical trial that will measure and report on an expanded panel of 150 genes selected by researchers and pharmaceutical partners. Oxford's clinical trial will utilise Life Technologies' multi-gene NGS test. 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," said Bell. "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," said Peach, "in which patients are quickly moved into appropriate trials based on their individual genetics. And, because almost all drug trials are delayed due to lags in enrollment, UK research will benefit from this model as well."
The 150 genes in the Oxford study 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.
Fast and economical Personal Genome Machines will enable affordable price point for nine gene report
The consortium will create and validate the new NGS-based test on the Ion Torrent(TM) Personal Genome Machine(TM) (PGM), a next generation sequencing platform that can sequence hundreds of genes in just two hours. 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.
"Rapid, cost-effective sequencing is taking us into a new genomic knowledge economy," said Paul Billings, M.D., Ph.D., chief medical officer of Life Technologies. "We are approaching an entirely new way to address, diagnose and treat cancer. In the near future, we see DNA sequencing as a routine part of patient care, generating a new kind of valuable information as a decision resource to physicians."
Life Technologies has a strong presence in the U.K., with over 700 employees in research & development, manufacturing, and commercial operations; its European headquarters is in Paisley, Scotland.