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tumor mutational burden

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.

NantHealth's net loss fell by 37 percent, to $14.7 million, as revenue from software-related revenue jumped by 23 percent while expenses fell.

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.

The firms will partner on studies needed to support and secure US regulatory approval for the Elio tissue complete assay.

PGDx and KingMed plan to provide tumor mutational burden testing to pharmaceutical companies for clinical trials in China and Hong Kong.

Researchers showed, retrospectively, that using a cutoff of 16 circulating DNA mutations they could identify patients who were more likely to respond to immunotherapy.

A Samsung University team found that mutation load measured with the Guardant360 liquid biopsy assay predicted response as well as tissue-based TMB.

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.

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