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The firm touts a new hybridization probe design, which it says will enable small, focused panels that reduce sequencing costs and assay time.
The method uses nanopore sequencing to analyze short cell-free DNA fragments from blood, providing results in as little as six hours.
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.
The investment bank upgraded the company's stock to an Outperform rating from Market Perform but lowered its price target to $37 per share.