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Cancer Research UK Close to Launching $26.5M Cancer Genetic Testing Program

By Matt Jones

NEW YORK (GenomeWeb News) – Cancer Research UK is preparing to launch a new program that aims to link research into cancer genes directly with clinical outcomes and serve as a proof-of-concept for personalized medicine on a large scale.

The long-term aim of the new Stratified Medicine Programme, a partnership with the UK government, pharmaceutical firms Pfizer and AstraZeneca, hospitals, and diagnostic labs, is set for official launch as soon as October. The effort seeks to establish a national service for making cost-effective genetic testing of tumors available for cancer patients and to build a national database of tumor genetic information, treatments, and outcomes that will be used for research into better treatments.

The project is funded with a total of £16.7 million ($26.5 million), including £5.5 million from CRUK and its partners, £5.6 million from the government's Technology Strategy Board, and £5.6m from CRUK's corporate collaborators.

In this first phase of the program the researchers will work with genetic testing labs to provide panel tests and with a number of hospitals to collect standardized tumor data. The effort initially will involve doctors in seven hospitals that will serve as clinical hubs and will recruit up to 9,000 people with six types of tumors who have consented to participate in the research.

The second phase of the project, not scheduled to begin for more than two years, will take the lessons learned about cancer tumors and treatment and roll out the program nationally through a partnership with the National Health Service and the National Institute for Health and Clinical Excellence.

"The thing that excites me about the program is that it combines the two aspects of stratified medicine," CRUK Director of Stratified Medicine James Peach told GenomeWeb Daily News in an interview last week.

"The first is the research — finding the new medicines, new treatments, and new protocols that we will actually need to put in place the genetic information that we'll have. And it is about collecting care data on a molecularly well-characterized set of patients. And so we'll do that by collecting routine clinical outcomes on 9,000 patients," he said.

"The second side ... is actually making sure we can deliver this in the health service. So we're working very closely with NHS to demonstrate a consolidated model of genetic testing where single labs will be serving a number of hospitals," Peach explained.

He said that the Stratified Medicine Programme "is reacting to [US National Institutes of Health Director] Francis Collins' call that "we need to start annotating some of the [clinical genomics] data that we have.

"It's no longer sufficient at this stage just to look at the genes. You need to be able to look at the clinical behavior that's associated to that genetic type."

For this program, that will involve collecting information from hospitals on patients' routine clinical diagnoses, treatments, and outcomes, so that researchers can "correlate a genetic type to treatment and to outcome and start building hypotheses for the future," Peach added.

All of this clinical data will be collected from patients at as many as 15 different hospitals and, after being handled by the seven clinical hubs and three partner labs (the names of which have not yet been made public) that will conduct the panel testing, it will be stored in the UK Cancer Registry for use by cancer researchers.

"We at CRUK will make that data available to ethically approved researchers in an anonymized format and hopefully will start to get anonymized data out there as soon as we can," he said.

In the first phase of the project, which lasts from 2011 through 2013, researchers will recruit patients with six tumor types, including breast, bowel, lung, prostate, ovarian, and melanoma cancers. During this initial phase, the results of these tests will not change patient care, but the results will be made available to clinical teams involved in patient care in order to demonstrate how this information could be used to help make clinical treatment decisions.

The second phase of the program will seek to use knowledge gained in the first phase to begin to broaden the program nationally, which could involve bringing in new technologies and increasing the cancer types that will be tested.

The ultimate aim is to develop a nationally standardized, high-quality, cost-effective genetic testing service and research database that will continue to grow and be a resource for researchers.

Peach hopes that when the program is completed it will have shown that "excellent cancer genetic testing [can be] delivered for patients in the NHS right now, so that patients could get the right tests, with the right quality, and the right costs. The second part is that we would have demonstrated that you can usefully connect routine clinical outcomes on a very large proportion of cancer patients and store this in a consented way that is useful for research."

Peach said that the larger aim is to move beyond cancer, a disease type that tends to generate innovations in research and treatments, and apply this approach to developing genetic testing for a wide swathe of human diseases.

"There are areas which really could benefit from this stratified approach," he said. "What we are demonstrating over the next two years is completely disease-neutral. You could put any patient sample, any disease type through this, and it should work as well."

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