The international firm is one of several pharmaceutical companies emphasizing new single-cell technologies to improve existing drugs and find new ones.
Researchers at Harvard, Peking University, and Yikon Genomics suggested that their noninvasive test is more specific than the prevailing biopsy-based method.
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.
