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 to many 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, medical director of the Medicare oversight agency.
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" exams of a single tissue sample at the same time, 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 are not. "" It has been proven to work in that situation and promotes a unapproved use of expensive drugs, "he said.
A better outcome in those situations is to guide people toward studies that test drugs that target those genes, Schilsky said.
Foundation Medicine, based in Cambridge, Mbadachusetts, and others have sold tumor profile tests for several years under more lenient rules governing lab tests, but insurers have refused to pay for tests, which cost around $ 6,000.
Now, approval The FDA guarantees quality, Shuren said, and the proposed government coverage for Medicare and other public insurance programs means that private insurers will more likely follow.
They eat them Public statements on the proposed coverage will be taken for 30 days. A final decision is expected at the beginning of next year followed by a price for the refund.
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 done so had a gene sequencing test.
"Many of these people have run out of treatment options," but the tests may indicate something new that could help, said Goodrich.
The impact is expected to be greater in lung cancer, since many of these tumors are at an advanced stage and multiple drugs are available that target genes to treat it.
The evidence is not strong enough to justify the use of these genetic profiling tests for the earliest stages of cancer. Patients receive standard and guidelines-based care in these cases.
In mid-November, the FDA also approved a genetic profile test developed by the Memorial Sloan Kettering Cancer Center, but is used almost exclusively in patients at that cancer center and is not expected to be a commercial test widely available.
Federal decisions will make genetic sequencing a more routine component of cancer care, "just as we normally look under a microscope" to clbadify the patient's stage of disease, said Dr. David Klimstra, chief of pathology in the oncological center.
Another leader in this field, Caris Life Sciences, says it also aims to obtain FDA approval for its widely used tumor profile test, now sold through laboratory certifications. He is also working on a newer tool to profile tumor genes from a blood sample. Many companies already sell these so-called liquid biopsy tests, although none have been approved by the FDA yet.