- Human Biospecimens
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March 30, 2018
Great news for cancer patients, their doctors and the scientists creating personalized medicine solutions:
Medicare will immediately begin covering next-generation sequencing (NGS) tests that help doctors prescribe specific cancer treatments likely to help individual patients based on their genetic profiles.
“CMS believes when these tests are used as a companion diagnostic to identify patients with certain genetic mutations that may benefit from U.S. Food and Drug Administration (FDA)-approved treatments, these tests can assist patients and their oncologists in making more informed treatment decisions,” the Centers for Medicare & Medicaid Services said in a news release. “Additionally, when a known cancer mutation cannot be matched to a treatment, then results from the diagnostic lab test using NGS can help determine a patient’s candidacy for cancer clinical trials.”
The coverage will apply to patients with advanced cancer (i.e., recurrent, metastatic, relapsed, refractory, or stages III or IV cancer). To qualify, a laboratory must be CLIA certified.
In announcing the coverage, CMS reported FDA approval of the FoundationOne CDx (f1CDx™) test. F1CDx™ is the first breakthrough-designated, NGS-based in vitro diagnostic test that is a companion diagnostic for 15 targeted therapies as well as can detect genetic mutations in 324 genes and two genomic signatures in any solid tumor, CMS said. It reportedly costs $5,800 per patient.
Going forward, CMS will be covering other FDA-approved or -cleared companion in vitro diagnostics when the test has an FDA-approved or cleared indication for use in that patient’s cancer and test results are provided to the treating physician for management of the patient using a report template to specify treatment options.
What this means
First, we can expect private insurers to follow Medicare’s lead, moving our health care system toward the day when genetic testing becomes the routine standard of care for patients with advanced cancers.
Second, this testing will generate large volumes of genomic cancer data to help fill treatment trails with “genetically matched” patients and accelerate discoveries in precision medicine.
Third, many of our clients are working diligently on these revolutionary NGS-based in vitro diagnostic tests and are nearing FDA approval. Their important work, as you can imagine, requires ample quantities of human cancer tumor samples and other biospecimens as they determine what biomarkers and analytes indicate a likely positive response to different therapies.
Our mission is to support the rapid advance of medicine, including precision medicine, and we will do everything we can to make the required specimens available on demand through the iSpecimen Marketplace. We will continue working with hospitals, labs and biobanks to continuously expand and streamline the biospecimen pipeline.
This is important work at an exciting time for medicine. New technologies are expanding possibilities for dramatically improved care, and these technologies are expensive. Even so, no cancer patient, regardless of age or means, should go without genetic testing that could ensure a more successful treatment.