The company said it has seen progress in efforts to get FDA approval for its tissue and liquid biopsy tests as data continues to accumulate for pan-cancer utility.
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 issue, discovered in late October, affected TMB reporting for up to 800 FoundationOne CDx tests during a short period of time and was quickly resolved.
Researchers showed, retrospectively, that using a cutoff of 16 circulating DNA mutations they could identify patients who were more likely to respond to immunotherapy.
The company is eyeing a launch for its IVD kits at the beginning of next year, as evidence grows for the integration of TMB analysis into the clinical care of cancer patients.
