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Canadian Cancer Group Says Genetic Testing Needs Oversight, Funding

NEW YORK (GenomeWeb News) — A provincial Canadian group that advises the government on issues related to cancer has issued a set of recommendations intended to ensure that residents of Ontario have "access to high quality genetic testing."

The Molecular Oncology Task Force of Cancer Care Ontario said in the report that genetic testing offers great promise for cancer detection and treatment, but also said that Ontario needs to become more involved in promoting development and use of these tests. It advised the province to create an oversight body for genetic testing, make genetic test approval mandatory, and develop a system to evaluate and fund new cancer tests.

"The advances in this field allow us to test a person for predisposition to cancer and for treatment to be tailored to the patient's cancer," CCO President and CEO Terrence Sullivan said in a statement. "It is imperative that our health system keep pace with these developments by making these tests available in a safe and sustainable manner."

The task force has said that Ontario needs immediately to start an oversight body that would advise "key stakeholders" on testing approval and licensing, funding, delisting of obsolete tests, quality assurance, and aligning oncology services with other genetic services.

The province also should implement a "mandatory approval process for each genetic test" performed by Ontario labs. The process should "ensure that only appropriately accredited and licensed labs" will report and interpret results of these tests.

The group also recommends that the province also should establish and fund an information-sharing mechanism to ensure that information is readily available to referring physicians and the public regarding test information, including their availability, how patients should be referred, what sort of data the tests will yield, what patients are eligible, and how specimens are to be managed.

Ontario also needs a "comprehensive and competitive approach to funding" that would address dynamic volumes and variation in the complexity of testing and clinical care, "as well as the costs associated with risk assessment and genetic counseling," CCO said.

Currently, according to the task force, there are "gaps in regulation and quality assurance, there is no effective mechanism to evaluate new tests for clinical utility, clinical and analytical validity, and cost-effectiveness, or to manage their introduction into clinical service."

The province also has no standardized process for determining which tests should be offered as part of its clinical oncology services, the group said.

Ontario lags behind other parts of the country in terms of the availability of molecular tests, and there still is a need to enhance the links between translational research and clinical care, according to the report. For the tests currently offered in Ontario, there is still geographic variation and "patients are being under-referred," the group explained.

Failing to meet these concerns, the group explained, will leave Ontario with "insufficient infrastructure to meet growing demands and an inability to implement and fund new tests." Without "proper oversight and quality assurance mechanisms in place," the board warned, the "potential for a breakdown of the system that affects patient safety and treatment is a genuine risk."

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