lunes, 26 de mayo de 2014

Oncology community scrutinizing obstacles to personalized medicine : Oncology Practice

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Oncology community scrutinizing obstacles to personalized medicine : Oncology Practice

Oncology community scrutinizing obstacles to personalized medicine

Personalized medicine is a reality for many cancer patients, and getting closer for others, but the oncology community is struggling with a number of questions surrounding genomic testing, a key to providing that care.
As a result, oncology leaders have started to take a closer look at how to resolve these issues, and how to do it as quickly as possible.
Among the most basic questions are when to use the testing, what to do with the information that’s generated, and how to secure reimbursement for diagnostics that may not have fully proven their clinical utility.
The science of genomics – from profiling a tumor’s genetic make-up to sequencing a cancer patient’s entire genome – is growing exponentially, leading to a rush to commercialize diagnostics based on the discoveries and a push among big cancer centers to leverage the knowledge to help develop therapeutics and inform clinical trials. Meanwhile, the Food and Drug Administration hasn’t articulated a clear regulatory strategy around genomic testing.

Mark Fleury, Ph.D.

"We need an infrastructure in place that quickly translates verified advances in treatment into practice," said Mark Fleury, Ph.D., of the American Cancer Society Cancer Action Network (ACS CAN). Now, genomic advances are relying on what he calls "passive diffusion."
Currently, there’s a kind of free-for-all, agreed Dr. Richard L. Schilsky, medical director of the American Society of Clinical Oncology.
"People need tests to guide treatment decisions, but there are very few controls over how tests are offered and developed," said Dr. Schilsky. He also noted that there is not a huge evidence base yet on the usefulness of some of the testing.
The oncology community is trying to bring some civility to the "Wild West" of genomics, starting by establishing standards, Dr. Schilsky said.
Among the issues being discussed:
• What genetic variants should oncologists be testing for in all common cancers?
• What is level of evidence that supports testing for those particular variants?
• What are the recommended clinical actions to be taken once certain variants are discovered?
• What information should be reported to the oncologist?
• What information should be reported to the patient, and how?
In early April, ASCO convened a meeting of representatives from clinical oncology, pathology, the genetic sequencing community, and the regulatory community, among others, to discuss those issues and more, Dr. Schilsky said. "We didn’t come away with any consensus, but we put all the issues on the table," he said.

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