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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 firm is moving into a larger facility after its first full year of profitability and planning new hires to support its plans to bring liquid biopsy kits through the FDA.
Researchers separately found that the assay had high concordance with other techniques in cancers including colorectal and endometrial carcinomas.
The 4,000-participant study will use a digital enrollment platform and will provide free genetic testing as well as support from doctors and genetics experts.
The new Kidney Profile combines two existing tests for chronic kidney disease and could be critical in addressing the under-diagnosis of the ailment.
PGDx has the exclusive rights to develop both tissue- and blood-based diagnostics using MSK’s TMB-related intellectual property.
The collaboration aims to eliminate barriers to testing for chronic kidney disease by standardizing the method for testing for the condition, thereby improving the comparison of test results between labs.
Some industry players are accusing CMS of advancing backdoor LDT regulation by proposing to cover NGS tests with FDA approval/clearance, except in a limited setting.
The authorization implements regulatory strategies the FDA advanced with industry stakeholders, though labs may still be more inclined to take the CLIA route, as long as it is available.
The agency said that its action on MSK IMPACT "advances a policy framework that paves the way for the efficient review and availability of other NGS-based cancer profiling tools."