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Thursday, December 07, 2017 8:35:35 PM
There was something worth noting and I don't think it was noted on this board yet.
One of the senators asked Dr. Gottlieb about a laboratory test that received approval. It had been given breakthrough designation, and it was given simultaneous CMS coverage at the same time (which is new, I guess).
Anyhow... this laboratory test approval is for F1CDx by Foundation Medicine. Why this seems relevant to me is that their test is for genetic mutations to help identify which treatments might be best for patients. And there has been a lot of talk about the importance of such tests in the future treatment of GBM.
So I took a quick look at Foundation Medicine's website. A quick look at the FoundationOne "Genomic Testing" link - given below - indicates that this flagship assay is for solid tumor cancers including but not limited to: Non-Small Cell Lung Cancer (NSCLC), Colorectal, Breast, Ovarian, and Melanoma.
They feature two clinical studies that are as follows:
Tumor Mutational Burden as an Independent Predictor of Response to Immunotherapy in Diverse Cancers
and
Clinical utility and treatment outcome of CGP in high-grade glioma
This indicates to me there must be a fairly high level of interest in profiling gliomas - and if DCVax-L were approved, it could be used to determine whether this treatment would work more effectively on the patient's GBM, depending upon the type.
Anyhow, I did think this merited a mention.
Also, Dr. Lamar Alexandar, of Tennessee (home of Cognate) the Chairman of the Senate Health, Education, Labor and Pensions Committee, and the Senate Sponsor of the 21st Century Cures Act, had this to say to Dr. Gottlieb at minute 56:15:
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