Though the test is already commercially available, the firm met with the FDA last year to discuss plans for a randomized controlled trial to support regulatory approval.
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.
Data from the GUIDED study will be central to commercial payor discussions, a Medicare LCD reconsideration request, and eventually expansion into the primary care market.
One of the largest repositories of molecular brain cancer data in the world, the enhanced REMBRANDT is more comprehensive than an earlier NCI-hosted version.
Mainichi reports that 43 percent of Japanese individuals said they did not want to eat agricultural products that had been modified using gene-editing tools.
