Biomarker test approval marks breakthrough in war on cancer
Thursday, December 07, 2017
The National Cancer Institute estimated 1,685,210 new cases of cancer diagnosed in 2016 in the U.S. and that 595,690 people would die from the disease. These numbers have placed cancer research and drug therapy treatment at the forefront of actions for most healthcare institutions and research facilities.
In the war against cancer, there have been ongoing attempts to develop not only novel treatment approaches but also ultimately find a cure.
The movement toward the early detection and treatment of different forms of cancer has been a focus of the medical and scientific community for several years. The discovery of new methods or strategies to combat the disease only serves to illustrate the milestones that are being made toward a potential cure.
One recent milestone that has been achieved comes in the form of a new cancer biomarker test, approved by the Food and Drug Administration on Nov. 30. FoundationOne CDx has the ability to identify specific genetic mutations in 324 genes and two genomic signatures in tumors. This includes genes for cancers that are found in the lung, colon, ovaries, breasts and in the skin.
As a result of this test, healthcare professionals can identify patients with these tumors, who can then benefit from the use of the various targeted treatment options that are available. The FoundationOne CDx (FICDx) test can allow patients to be diagnosed more quickly as well as potentially improve outcomes from a diagnosis that is made sooner rather than later.
"The F1CDx can help cancer patients and their healthcare professionals make more informed care decisions without the often invasive process of extracting tumor samples multiple times to determine eligibility for a single treatment or enrollment in a clinical trial," said Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health (CDRH) in a statement.
"With the run of one test, patients and healthcare professionals can now evaluate several appropriate disease management options."
In terms of affordability, the Centers for Medicare and Medicaid Services (CMS) requests that Medicare should take on the costs of this test or provide coverage, which would mean that a substantial amount of the cost would not be incurred by patients. According to FDA Commissioner Scott Gottlieb, M.D., the approval of F1CDx can also help reduce healthcare costs in the long run.
"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 healthcare costs," Gottlieb said.
The overarching goal is to expeditiously and effectively detect patients who present with these genes and provide them with access to treatment. The approval of FICDx can be seen as a stepping stone toward the approval of equally or superior diagnostic tests that can accurately identify the presence of genetic mutations and the development of cancer.
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