Next generation sequencing (NGS) test receives both FDA approval and proposed medicare coverage by the CMS for patients with advanced cancer
The Announcement
In November, the Federal Drug Administration (FDA) approved a breakthrough next generation sequencing (NGS) test for tumor-gene profiling in patients with recurrent, metastatic or advanced stage IV cancer known as the FoundationOne Companion Diagnostic (F1CDx) test.
In a parallel review process, the Centers for Medicare & Medicaid services also proposed coverage of FD1CDx in order to provide quicker access to Medicare beneficiaries.
Prior to this announcement, it was very difficult for patients covered under Medicare to receive access to NGS testing. This decision will allow for increased access to healthcare coverage for a large portion of the US population.
What is a companion diagnostic test?
Companion diagnostic tests are tests that are typically linked to a specific drug for therapy. These diagnostic tools help clinicians decide if a particular drug or treatment will be efficacious and benefit the patient while mitigating risks and serious side effects.
How will this test help CRC patients?
The newly-approved NGS FD1CDx test can distinguish mutations in over 300 genes at once in any of the 5 solid tumor types. Not only do results from the breakthrough genetic profiling test help determine which of the 15 FDA-approved targeted treatment options will then be most beneficial to a patient, but it only requires one tissue sample to do so.
Results from these tests will provide insight into eligibility and clinical trial enrolment, guiding a patient’s treatment decisions.
According to Dr. Dusty Deming from the University of Wisconsin, “in the ever expanding era of precision medicine, molecular testing is critical to determining the best treatment strategies for patients with cancer. In order to make this a possibility for more patients, improved coverage of this type of testing is essential.”
Among the numerous genetic mutations that the FD1CDx test can detect are molecular changes that are a result of microsatellite-instability (MSI- H).
Findings from the Fight CRC/ CI Immunotherapy workgroup blueprint, published in November 2017, determined that biomarkers and identified treatment methods need to be integrated into the routine management of CRC.
NGS tests such as FD1CDx can help make targeted treatment a more viable option for clinicians and patients, using biomarkers to guide these decisions.
Do you know your biomarker? Check out our Biomarked campaign and resources!
Fight CRC’s Public Comment
In light of this monumental announcement from the FDA and CMS, Fight CRC took advantage of the public comment period, with help from members of our Medical Advisory Board and patient advocates, to support the proposed decision memo with requests for clarification before finalization of the guidelines.
Highlights from our letter included:
- Clarification on the requirement that “patients have not been previously tested using the same NGS test”. (This implies that a patient tested with one NGS test would be excluded from future tests, but it wasn’t clear whether a patient could be tested with a different brand of a NGS test.)
- Additionally, we emphasized our support on the requirement that the NGS test be covered if data is gathered, helping to assess the clinical validity of the tests.
- We noted however, that it is necessary to find an efficient collection and entry method so it doesn’t become a burden on physicians.
Take a look at the proposed memo here
You can read our public comment in full here: PDF File
As the leading CRC patient advocacy organization, we hope that our comments on this proposed decision memo lead to better diagnostic and treatment options for patients.
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