Companion Diagnostics

News on companion diagnostics and drug/test co-development.

Presentations largely reflected negatively on the utility of PD-L1 for stratifying response, but pivotal new data on tumor mutational burden as assessed by Foundation Medicine's genomic sequencing panel.

The companies plan to develop a broad NGS panel to analyze all known biomarkers for cancer drugs, including tumor mutation burden and microsatellite instability.

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.

The ctDNA assay will be used to select patients for Phase 3 of Five Prime's registrational trial investigating bemarituzumab in gastric cancer patients.

The firm is in the midst of evaluating its strategic options and has hired Raymond James to assist in the process, which could include the sale of the firm, it said.