In BriefThe Food and Drug Administration has approved a "breakthrough device" that can match cancer patients with individualized treatment regiments with just one test. This device can detect 324 specific genetic mutations and two genomic signatures.
The Food and Drug Administration (FDA) announced that it has approved a “breakthrough device” that has the potential to match cancer patients with individualized treatment regiments with just one test. This could allow doctors and patients to choose treatments that are most likely to be effective for specific types of cancer — and to make those decisions sooner.
The test, called FoundationOne CDx, is what’s known as a “companion diagnostic.” This means that rather than screening patients for cancer itself, the test is used on patients who’ve already been diagnosed with cancer in order to determine which drugs or therapies are best suited to their individual case.
Other companion tests have been developed in the past, but they could only check to see if one particular drug would be effective for treating a patient’s cancer. This new device can detect a wide range of genetic mutations, which allows it to screen the potential effectiveness of 15 different treatment options.
The device sequences the DNA from a tumor sample, and detects 324 specific genetic mutations with an accuracy of about 94.6 percent, as determined by clinical trials. Additionally, the device can also determine if the tumor has either of two “genomic signatures;” molecular changes that can occur in cancer cells and can influence how that cancer is classified.
Improving Patient Care
This test could spare cancer patients from undergoing duplicate biopsies as well as accelerate a patients assessment, allowing him or her to begin treatment earlier. It could also allow doctors to match patients up with combination treatments consisting of multiple drugs (which, in some cases, may be more effective than using a single drug).
Among the types of solid-tumor cancers that this device could help treat are lung, skin, colorectal, breast, and ovarian cancer. The FDA panel, which bestowed the “breakthrough device” status on FoundationOne CDx, was so convinced of the test’s potential that the agency has proposed it for coverage by Medicaid and Medicare. Such a move could improve the lives of many cancer patients, according to FDA Commissioner Scott Gottlieb.
“By leveraging two policy efforts aimed at expediting access to promising new technologies, we’ve been able to bring patients faster access to a breakthrough diagnostic that can help doctors tailor cancer treatments to improve medical outcomes and potentially reduce health care costs,” Gottlieb said in an FDA press release.
While the device does not specifically “cure” cancer, it is being lauded as an enormous advancement in cancer treatment. FoundationOne CDx joins other novel cancer tests, such as one that requires only a drop of blood and another that can detect cancer years before symptoms arise, that brings us one step closer to a world that is cancer free.