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Companion Diagnostics

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

The company plans to submit a companion diagnostic version of its sequencing-based liquid biopsy test Guardant360 to various regulatory bodies.

Insight's portfolio includes a gene expression-based immuno-oncology assay for therapy response prediction.

The company is beginning a multi-site Phase II trial designed to establish that its approach can identify patients who will respond to immuno-oncology drugs.

The approval will allow clinicians to identify NSCLC patients with ROS1 fusion genes who could benefit from treatment with Rozlytrek.

The drug is approved as a maintenance treatment for platinum-responsive metastatic pancreatic cancer patients with germline BRCA1/2 mutations.