The tool, which has been validated in two independent patient cohorts, uses artificial intelligence to predict patients likely to benefit from upfront FOLFOX.
The firm said the assays detect all classes of alterations including genomic signatures for microsatellite instability, tumor mutation burden, and loss of heterozygosity.
While the guidance may lead to more streamlined CDx indications in precision oncology, test developers will still need to generate evidence, perhaps with limited pharma support.
In response to CMS reopening its national coverage determination to address its germline testing policy, stakeholders point out areas of concern and confusion.
Get the latest news from Biocept, Caris Life Sciences, PerkinElmer, Inform Diagnostics, CompuNet Clinical Labs, and Drawbridge Health for the week of 7/26/19.
