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CMS's move to restrict coverage could limit test access for early-stage cancer patients and negatively impact lab revenues.
MSK researchers showed that high TMB may be associated with improved survival across tumor types, but the cut-offs for high and low status will vary based on histology.
The draft guidelines have intrigued industry players interested in pursuing labeling that would allow their CDx to direct treatment for a class of drugs instead of one drug.
Qiagen and Foundation Medicine will develop tissue- and plasma-based companion tests to identify best responders to the PI3K inhibitor alpelisib
An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.
With sequence data for more than 118,000 tumors profiled at Foundation Medicine, investigators tracked PDL1 amplification prevalence and possible treatment implications.
New tumor profiling papers stemming from prior clinical trials led to informative mutations in early-stage, ER+/HER2- breast cancer and lung squamous cell carcinoma.
At ASCO, researchers presented on the WINTHER trial, which despite setbacks showed that both DNA and RNA analysis can be used to guide personalized treatment strategies.
This data is helping the agency understand how precision oncology drugs and tests are prescribed outside of clinical trials and in the broader cancer community.
The projects, organized by Friends of Cancer Research in the US and the Quality Assurance Initiative Pathology (QuIP) in Germany, are comparing different TMB assays.