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Companion Diagnostics

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

The test will be used to identify which advanced or metastatic breast cancer patients with PIK3CA mutations are likely to respond to Novartis' alpelisib.

Eurofins Scientific will help Adial validate a companion diagnostic for a drug being developed and identify patients for enrollment into a Phase III trial.

The next-generation sequencing assay is intended for use in identifying patients with ROS1, NTRK1-3, and ALK gene fusions in advanced solid tumors.

Organizations including Quest, J&J, Medecision, and the ACCP have formed the Get the Medications Right (GTMRx) Institute to promote PGx testing.

The agency wants to waive the "substantial clinical improvement" criteria for medical devices for two years and increase the add-on payment.