The groups have written draft recommendations and are now asking for public comment from pathologists and other stakeholders.
Presentations at this month's ASCO meeting demonstrated how efforts are advancing to determine when and how longitudinal ctDNA testing will be useful for oncologists.
Meeting presentations supported tweaking the clinical interpretation of Genomic Health's Oncotype DX and bolstered Biotheranostics' Breast Cancer Index.
The company reported that its genome-wide methylation approach could detect 77 percent of stage II cancers in its ongoing case-control CCGA study.
Thrive Earlier Detection is banking on targeted detection of frequent cancer mutations, coupled with protein markers, while competitors turn to genome-wide approaches.
The diversity of the organizations that have signed the letter to CMS demonstrates widespread concern over this policy.
The company highlighted growth in demand for its test , and is now ramping up marketing and focusing on its IVD development plans.
The updated guidelines confirm HER2 gene amplification assessed by ISH and protein overexpression assessed by IHC are primary predictors of responsiveness to HER2 therapy.
The company is planning to submit the drug and a companion diagnostic that can identify patients with FGFR alterations with the FDA in the second half of 2018.
A new trial has compared the two most prominent tests, showing that both have clear predictive ability, but leaving several other questions unanswered so far.