In patients with Luminal B tumors the CDK4/6 inhibitor ribociclib along with hormonal therapy produced response rates similar to multi-agent chemotherapy.
Investigators compared expression in different men across the genes from three commercial panels, arguing that the findings highlight important unknowns.
Authors concluded that all three assays — Oncotype DX, EndoPredict, and Prosigna — met Canadian thresholds for cost-effectiveness and urged caution in considering the findings.
The researchers have used nCounter, an FDA-cleared platform from NanoString Technologies, to develop their gene expression assay for subtype classification.
Using samples from different points in patients' treatment, researchers employed a variety of tools, including NanoString's GeoMx DSP, to explore potential response markers.
Although a draft guidance last month recommended against use of molecular tests to guide chemotherapy, the group's finalized decision is subject to price negotiation and other adjustments.
