BMS amended an ongoing Phase III study of Opdivo and Yervoy to evaluate outcomes based on tumor mutational burden using Foundation Medicine's NGS companion diagnostic.
Biodesix will work with university researchers on an assay to help identify non-small cell lung cancer patients likely to respond to certain immunotherapies.
The real-time PCR-based test is designed to identify EGFR mutations in circulating tumor DNA in plasma samples.
An extended labeling claim has added detection of three additional EGFR mutations to help ID NSCLC patients for whom Boehringer Ingelheim's Gilotrif is indicated.
The trial aims to demonstrate the utility of Biocept's Target Selector PD-L1 assay in patients diagnosed with non-small cell lung cancer.
The NGS-based test, which was approved by the FDA in June, will be now available to the insurers' members, who have non-small cell lung cancer, in four states.
Their study suggests that commercial IHC assays for PD-L1 can yield compatible and transferrable results if handled appropriately.
Gencurix's assay can be used to select which non-small cell lung cancer patients will respond to tyrosine kinase inhibitors.
Investigators will use Biocept's liquid biopsy tests to detect ALK rearrangements both at baseline and to monitor treatment response and resistance mechanisms.
The Ventana assay is an immunohistochemistry-based companion diagnostic that identifies ALK-positive NSCLC patients eligible for the Novartis drug Zykadia.