Multiple Myeloma an incurable disease, but I have spent the last 25 years in remission using a blend of conventional oncology and evidence-based nutrition, supplementation, and lifestyle therapies from peer-reviewed studies that your oncologist probably hasn't told you about.
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I don’t think its hyperbole to say that next-generation sequencing is the future of multiple myeloma. Or maybe I should say that next-generation sequencing is the future of multiple myeloma diagnostics. Yes, this is a tall statement. Let me try to make my case based on the articles linked and excerpted below.
Multiple myeloma is a very heterogeneous cancer. This means that there is a great deal of genetic variability among MM patients. One of the most common phrases written in online MM forums is “everybody’s different.” One person can fly through induction therapy reaching complete remission in two or three cycles of chemotherapy while the next person, undergoing the exact same therapy regimen barely responds.
Life as an multiple myeloma patient can be made or broken at any of these three points in time. According to the bottom article linked below, next-generation sequencing can address all three of these challenges improving oncologic decision-making at every juncture. After all, an oncologist is only as good as the diagnostic information he or she receives. Next-generation sequencing provides the MM patient’s individual genetic results meaning, this sequencing provides the patient with the correct multiple myeloma diagnostic information.
From ’12-’17 or so, conventional oncology made great strides learning about the genetic make-up of MM. And a great deal more work needs to be done. MM diagnostic needs to continue to improve.
One way to slow or inhibit understanding of next-generation sequencing would be to restrict how oncologists use genetic-sequencing technology. According to the top article below, the FDA is considering limiting the options of oncologists regarding next-generation sequencing. Certainly, it is too early to tell what will happen to this fast-changing technology. We will have to watch and wait for now.
Wall Street Journal 2/26/18
At issue is whether reimbursements will be available to most physicians, hospitals, and patients with a diagnostic technology known as next-generation sequencing. A cornerstone of the emerging field of precision medicine, next-generation sequencing (NGS) tests analyze molecular changes that occur in cancerous tumors and show up in biopsies.
To fight tumors, DNA-sequencing-based tests can determine how genes and mutations differ from one patient to the next. Next-generation sequencing tests enable oncologists to prescribe and administer customized, highly targeted drug therapies. The technology limits patients’ exposure to unnecessary toxic drugs and helps doctors make vital treatment decisions. Hundreds of thousands of cancer patients have already received NGS testing.
The proposed new CMS policy would abruptly change the way NGS testing is regulated and administered. It would drastically limit insurance coverage by requiring that tests be approved by the Food and Drug Administration. Current NGS tests are conducted at accredited clinical laboratories and premier academic medical centers under strict regulation. They are as accurate and reliable as FDA-approved testing. There is no evidence that restricting reimbursement to FDA-approved tests would improve care.
Under the proposed policy, only one of the hundreds of laboratories that currently offer NGS testing would meet all the new reimbursement requirements. The policy would in effect force clinicians and institutions to send all NGS testing to a single vendor, Foundation Medicine.
This is unfair to cancer patients. The proposal would result in a monopoly, allowing price manipulations, decreasing quality, and potentially contributing to market failure. It would turn the entire genomic-testing industry upside-down. The FDA is already unable to keep up with advances in precision medicine. Restricting access to cutting-edge molecular testing would stifle growth in precision medicine at approved testing sites nationwide. The limits could prevent desperately needed innovation, setting back progress in genomic testing and oncology by at least a decade.
The CMS proposal is another example of faulty government regulation in health care, this time at the expense of cancer patients. This government intervention is more than a regulatory nuance in a reimbursement issue. It’s a matter of life and death.
Mr. Elemento is director of the Caryl and Israel Englander Institute for Precision Medicine at Weill Cornell Medicine and a co-director of the Genetics, Epigenetics, and Systems Biology Program in the Sandra and Edward Meyer Cancer Center.
“Abstract- As a result of multiple technological and practical advances, high-throughput sequencing, known more commonly as “next-generation” sequencing (NGS), can now be incorporated into standard clinical practice. Whereas early protocols relied on samples that were harvested outside of typical clinical pathology workflows, standard formalin-fixed, paraffin-embedded specimens can more regularly be used as starting materials for NGS…
For clinical oncology providers, understanding the potential and the limitations of DNA sequencing will be crucial for providing genomically driven care in this era of precision medicine…
NGS utility- There are three general ways that NGS can aid a clinician.