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  • Writer's pictureKirk Hartley

Lawyers on All Sides Soon Will See More and More Reports on Tumor Mutations

Changes in the world of science mean that tort lawyers of today and tomorrow soon will see and learn far more about genomic mutations in tumors. Why? Because genomic analysis of tumors is becoming even more common place, and concrete steps are underway to increase the amount of and efficacy of genomic testing of tumors.

Today, Foundation Medicine is by far the leading national business providing genomic analysis of tumor material. Tests of that sort are now the standard of care at teaching hospitals, although some of them run their own tests, as opposed to having Foundation Medicine run the tests. Tomorrow, genomic testing will grow even more, and there will be more providers of testing services. The latest push in that direction arrived this week as four of the nation’s five best cancer centers agreed to join with Illumina in helping to define the standards for the next generation of genomic testing of tumors.

Set out below is the press release from Illumina – it is well worth reading in full, more than once, in order to see where the future will be going. And make no mistake, the future will go there, and far faster than most would imagine.


“Actionable Genome Consortium Forms with Cross Disciplinary Leaders from World-Renowned Cancer Institutions

Dana-Farber Cancer Institute, Fred Hutchinson Cancer Research Center, MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center and Illumina are Founding Members Consortium Will Recommend Standards for Applying Next-Generation Sequencing to Cancer Tumors

BOSTON & SEATTLE & HOUSTON & NEW YORK & SAN DIEGO–(BUSINESS WIRE)–Sep. 8, 2014– World-renowned cancer centers and Illumina, Inc. (NASDAQ:ILMN) today announced the formation of the Actionable Genome Consortium (AGC), an effort to recommend openly published standards for the widespread use of next-generation sequencing to guide decision-making in clinical oncology. The core remit of the AGC is to define the principles and content of the “cancer actionable genome” — a comprehensive description of genomic alterations that define individual patients’ tumors. Once defined, the actionable genome will help oncologists and pathologists determine optimal therapeutic and testing strategies to improve patient outcomes. Currently, the definition of what is actionable varies, and clinical interpretation of genomic tests is challenging even for experts. Further, the majority of patients lack access to multidisciplinary Tumor Boards, such as those at major cancer centers, which define what constitutes an actionable event in a tumor. “Oncology is as ready as any area of medicine to see the genomic revolution become the core of medical practice. Advances made over the past several decades, including those in next-generation sequencing, have set the stage to re-think how cancer should be diagnosed, classified and treated,” said Charles Sawyers, M.D., chair of the Human Oncology and Pathogenesis Program at Memorial Sloan Kettering Cancer Center and a Howard Hughes Medical Institute Investigator. “Patients will be more likely to receive the proper targeted course of therapy from the outset when the community oncologist is aware of standard molecular testing procedures and how to interpret these test results.” “It is clear that solutions to cancer lie with the combined resources of leading cancer research institutions. The AGC is an exciting model for bringing together shared discoveries and wisdom to benefit cancer patients,” said Gordon Mills, M.D., Ph.D., chair of the Department of Systems Biology at The University of Texas MD Anderson Cancer Center. “The AGC is paving the way to truly transform cancer care by enabling the combination of clinical and molecular data at an unprecedented scale. The AGC is part of a national effort to promote this transition and get it right,” said Eric Holland, M.D., Ph.D., director of Solid Tumor Translational Research at Fred Hutchinson Cancer Research Center. “Developing standards that will facilitate the use of genomics in personalized treatment is an exciting advancement that will lead to real benefits for patients,” said Barrett Rollins, M.D., Ph.D., Chief Scientific Officer at Dana-Farber Cancer Institute. The AGC has developed and will publish a list of actionable events, including recommendations for:

  1. best practices for biopsy, sample storage and transport, and extraction;

  2. technical performance standards for DNA sequencing;

  3. standards for variant calling, annotation and interpretation; and,

  4. guidelines for the format and content of clinical reports.

Once adopted into medical guidelines, the recommendations of the AGC will pave the way for the development of in vitro diagnostics, additional information to support regulatory oversight of genomic testing for cancer, and reimbursement of tests that will improve patient outcomes. Additionally, the AGC will include a research arm that will leverage the scientific, clinical and technical capabilities of the member institutions for novel collaborative, cross-institutional projects aimed at grand challenges in molecular oncology.

“The AGC represents an extraordinary gathering of experts and decision-makers in clinical and molecular oncology, pathology and technology who, by proposing the standards by which every tumor will be sequenced, will move the field of clinical oncology into the era of precision,” said Rick Klausner, M.D., former Director of the National Cancer Institute and current Senior Vice President & Chief Medical Officer at Illumina. “Widely available, standardized genomic testing of tumors can be the means by which precision oncology and therefore precision medicine begins to live up to its promise.”

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