Giving Patients Access to “Innovative Diagnostics”
Discussion on the issue began several months ago when Foundation Medicine received FDA approval for F1CDx, the first broad genomic cancer test of its kind. The current cost for for F1CDx is $5,800.
At the time of the announcement, CMS administrator Seema Verma issued a statement explaining the decision. CMS believes that it will give cancer patients “enhanced access and expanded coverage when it comes to innovative diagnostics.”
Coverage for genomic and molecular cancer tests that are still in development and not yet FDA-approved does not change with the new policy. U.S. regional Medicare administrative contractors will retain discretion in regards to payment for such testing.
Opening the Door to Accurate Evaluation
For the time being, Foundation Medicine will likely see a surge in the number of specimens submitted to them for testing. In the big picture, the CMS decision will encourage researchers to gather the evidence needed for FDA approval of additional tests.
Experts predict that within a few years another half-dozen companies will join Foundation Medicine in offering FDA-approved testing. One scientist called the decision a “major advancement for precision medicine.”
Genomic Testing and Cancer Immunotherapy from Issels®
Researchers at the Institute for Research in Biomedicine (IRB) in Barcelona set out to study estrogen-positive (ER+) breast tumors that feature long periods of asymptomatic latency. This type accounts for 80 percent of breast cancer cases.
The Barcelona team identified a protein kinase called MSK1 as the primary regulator of dormant metastases. After examining clinical samples from patients, the researchers determined that ER+ breast cancer tumors that don’t express MSK1 tend to suffer earlier relapse, while those that do express MSK1 experience later metastases.
Breakthrough in Breast Cancer Treatment
Head researcher Roger Gormis explained that little was previously known about why breast cancer metastasis time varies from one patient to another. Study results also showed that suppressing MSK1 causes faster-growing cancer cells that have a greater chance of metastasizing.
Benefits of the study are two-fold:
– Doctors may be better able to identify patients who are more likely to relapse and adjust treatment protocol.
– Scientists may be able to develop a treatment that mimics the role of MSK1, thereby keeping metastasis dormant for as long as possible.
Effective Late-Stage Cancer Treatment at Issels®
Our non-toxic, personally tailored immunotherapy programs have effectively treated patients with late-stage and therapy resistant cancer of all forms, including breast, lung and colorectal. Contact us to learn more about why Issels® is the leader in state-of-the-art immunotherapy treatments.