Earlier this month, the FDA granted approval
to Foundation Medicine’s first-of-a-kind comprehensive companion diagnostic test for solid tumors, FoundationOne CDx. While it gives patients the ability to be accurately matched with a targeted therapy, this test also opens doors to the development of new target therapies, explained Stuart Goldberg, MD, chief scientific officer, Cota, in an interview with The American Journal of Managed Care®.
The comprehensive genomic profiling test looks at the 324 genes known to drive cancer growth. “This test is designed to try and find specific mutations, driver mutations, that we think may cause or accelerate the solid tumor cancers,” explained Goldberg.
FoundationOne CDx marks a new era in precision medicine where a doctor can get a clearer picture of a patient’s cancer, being able to better direct them toward a clinical pathway. The test will identify patients who will benefit from targeted therapies; an estimated 1 in 3 patients across 5 common advanced cancers will likely be matched with one of the 17 on-label targeted therapies.
“What you’re trying to look for is: is there a gene that is altered or mutated, and is that gene so called actionable? So, do we have a pill or targeted therapy to turn that gene off, and if that gene is what’s causing that cancer to get angry, maybe by turning off that gene you can slow down the progression of the cancer or maybe even put the patient in remission,” said Goldberg.
The best example of this can be seen in lung cancer, according to Goldberg; about 1 in 3 lung cancer patients have mutations, and it’s been shown that if they are “turned off,” the cancer will slow down. The test also has potential benefits for patients with a less common type of cancer, because while the test will test for all 7 mutations, it will also test for 300 others.
With this ability, the test will also allow doctors to refer patients for clinical trial participation if there is no available therapy, as well as potentially open the door to new targeted therapy drugs. If it’s discovered that a lot of patients have a certain mutation, there is a possibility that someone will start developing a drug for it, said Goldberg.
“So now when we get beyond the standard lung cancer, colon cancer, breast cancer—beyond the big ones—the fact that we can now take these rarer cancers, where we may not have had ideas of what to do, and do these genetic tests will help patients, hopefully dramatically," he said.
Until now, there has been difficulty getting insurance companies to cover these types of tests, with the argument that if there are 4 available targeted therapies, why not just test for those 4 genes, and it will be cheaper. However, Goldberg argued that getting more information from the hundreds of tested genes will pave the way to the being able to target more genes.
Providing relief for physicians and patients, CMS’ joint approval of FoundationOne CDx will cover the test, which runs for about $3000 to $5000, according to Goldberg.