Guardant Health, AnHeart Therapeutics team on NSLC companion diagnostics

Guardant Health announced a strategic collaboration on the development, regulatory approval and commercialization of the Guardant360 CDx and Guardant360 TissueNext assays as companion diagnostics for taletrectinib in the United States and European Union. Taletrectinib is an investigational ROS1 inhibitor for the treatment of adult patients with advanced or metastatic ROS1-positive non-small cell lung cancer NSCLC . AnHeart received U.S. Food and Drug Administration Breakthrough Therapy Designation BTD for taletrectinib on August 1 , for the treatment of adult patients with advanced or metastatic ROS1-positive NSCLC who are ROS1 tyrosine kinase inhibitor treatment naive or previously treated with crizotinib. BTD is intended to expedite the development and regulatory review of investigational treatments for serious or life-threatening conditions when preliminary clinical evidence indicates that the drug has the potential to substantially improve clinical outcomes compared with available therapies. The collaboration will focus on the use of the Guardant tests for comprehensive genomic profiling to identify patients with the specific tumor mutations that are targeted by taletrectinib.