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The company said it will seek FDA approval for the assay, an expanded version of FoundationACT, as a CDx for targeted therapies and as a tumor mutation profiling assay.
A private payor survey by ClearView Healthcare Partners found that medical directors viewed CMS's decision with caution; half had no plans to align commercial plan coverage.
A perspective that hasn't gotten as much attention is that the CMS draft coverage decision could be bad for patients by increasing off-label drug use based on the results of NGS panels.
BMS amended an ongoing Phase III study of Opdivo and Yervoy to evaluate outcomes based on tumor mutational burden using Foundation Medicine's NGS companion diagnostic.
Foundation Medicine will provide genomic profiling for the EORTC's Screening Patients for Efficient Clinical Trial Access program.
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 companies believe the database can facilitate outcomes research, improve variant interpretations, inform drug development efforts.
There are now 100 sites in the US participating in the basket study, and soon trials with similar approaches will be available in Canada and 13 other countries.
Looking beyond PD-L1 expression, investigators from several clinical trials considered a range of potential biomarkers for immune checkpoint treatment response.