FDA approves the first test of its kind for the cancer gene profile – tech2.org

FDA approves the first test of its kind for the cancer gene profile



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Measure yields more information about what is driving patients' tumors


Marilynn Marchione, Associated Press

Published at 5:43 pm, Saturday, December 2, 2017

  •   Alison Cairnes, on the right, looks at images with her doctor, Shumei Kato, at the University of California at San Diego. Tumor profiles Cancer genes from Cairns helped Kato identify an effective treatment for his gastric cancer. Photo: Gregory Bull, STF / Copyright 2017 The Associated Press. All rights reserved.

Alison Cairnes, on the right, looks at images with her doctor, Shumei Kato, at the University of California at San Diego. Tumor profiles Cancer genes from Cairns helped Kato identify an effective treatment for his gastric cancer. less
Alison Cairnes, on the right, looks at images with her doctor, Shumei Kato, from the University of California at San Diego. The tumor profile of the cancer genes of Cairnes helped Kato identify an effective treatment for her … more

Photo: Gregory Bull, STF

The FDA approves the first test of its kind for the cancer gene profile


U.S. Regulators have approved a unique test that looks for mutations in hundreds of cancer genes at the same time, providing a more complete picture of what is driving a patient's tumor and helping to unite treatments with those defects.

The Food and Drug Administration approved the Foundation Medicine test for patients with advanced or widely disseminated cancer, and the Centers for Medicare and Medicaid Services proposed to cover it.


The double decisions, announced Thursday night, will make tumor gene profiles available for much more "It's essentially individualized and precision medicine," said Dr. Kate Goodrich, medical director of the Medicare oversight agency .

Better information

Currently, patients can be tested for individual genes if a drug is available to attack those mutations. It is a stalking and error approach that sometimes means multiple biopsies and lost time. In lung cancer alone, for example, you can check about half a dozen genes with individual tests to see if a particular drug is compatible.

The new FoundationOne CDx test can be used for any solid tumor such as prostate, bad or colon cancer, and examines 324 genes plus other characteristics that can help predict success with treatments that enlist the immune system.

"Instead of one or two, you have many" tests at the same time from a single sample of tissue, said FDA Dr. Jeffrey Shuren. The tests provide better and more information to guide the treatment and can help more patients seek and enroll in studies of new therapies, he said.

"This will be a radical change" for patients, said Dr. Richard Schilsky, medical director of the American Society of Clinical Oncology, the badociation of doctors treating the disease.

"In summary, I think this is good," but there is a risk that detecting a mutation will lead doctors and patients to try treatments that do not allow it. "" It has been proven to work in that situation and promotes a unspecified use of expensive drugs, "he said.

A better outcome in those situations is to guide people to studies that test drugs that target those genes, said Schilsky.

Foundation Medicine, based in Cambridge, Mbad., And others sold tumor profiling tests for several years under more lax standards governing lab tests.

But insurers have refused to pay for tests, which cost around $ 6,000. [19659011] New direction

Now, FDA approval gives quality badurance, Shuren said, and the government's proposed coverage for Medicare and other public insurance programs means that private insurers will or will continue.

Public comments on the proposed coverage will be taken for 30 days.

A final decision is expected early next year followed by a price for reimbursement.

Coverage is proposed for patients with recurrent, widely disseminated or advanced cancers in people who have decided with their doctors to seek additional treatment and who have not previously had a genetic sequence test.

"Many of these people have run out of treatment options," but the tests may indicate something new that could help, said Goodrich.

The evidence is not strong enough to justify the use of these genetic profile tests for the earliest stages of cancer. Patients receive standard care, based on guidelines in those cases.

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