FDA approves first-of-a-kind test for cancer gene profiling

U.S. regulators have approved a first-of-a-kind test that looks for mutations in hundreds of cancer genes at once, giving a more complete picture of what’s driving a patient’s tumour and aiding efforts to match treatments to those flaws.

The U.S. Food and Drug Administration approved Foundation Medicine’s test for patients with advanced or widely spread cancers, and the Centers for Medicare and Medicaid Services proposed covering it.

The dual decisions, announced late Thursday, will make tumour-gene profiling available to far more cancer patients than the few who get it now, and lead more insurers to cover it.

“It’s essentially individualized, precision medicine,” said Dr. Kate Goodrich, chief medical officer for the Medicare oversight agency.

Currently, patients may get tested for individual genes if a drug is available to target those mutations. It’s a hit-andmiss approach that sometimes means multiple biopsies and wasted time. In lung cancer alone, for example, about half a dozen genes can be checked with individual tests to see if a particular drug is a good match.

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

“Instead of one or two, you have many” tests at once from a single tissue sample, said the FDA’s Dr. Jeffrey Shuren. The tests give better and more information to guide treatment and can help more patients find and enrol in studies of novel therapies, he said.

“This will be a sea change” for patients, said Dr. Richard Schilsky, chief medical officer of the American Society of Clinical Oncology, the association of doctors who treat the disease.

“On balance I think this is good,” but there is a risk that spotting a mutation will lead doctors and patients to try treatments that haven’t been proven to work in that situation and promote more off-label use of expensive drugs, he said.

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

Foundation Medicine, based in Cambridge, Massachusetts, and others have sold tumour profiling tests for several years under more lax rules governing lab-developed tests. But insurers have balked at paying for the tests, which cost around $6,000.

Now, the FDA’s approval gives assurance of quality, Shuren said, and the government’s proposed coverage for Medicare and other public insurance programs means private insurers will more likely follow.

Public comments on the coverage proposal will be taken for 30 days. A final decision is expected early next year followed by setting a price for reimbursement.

Coverage is proposed for patients with recurrent, widely spread or advanced cancers, in people who have decided with their doctors to seek further treatment and who have not previously had a gene sequencing test.