Chugai Pharmaceutical Co. Ltd. said the Japanese Ministry of Health, Labor and Welfare approved the expanded use of FoundationOne CDx to identify patients who would be eligible for treatment with Roche Holding AG's Rozlytrek.
The diagnostic test can be used to detect genetic mutations in any solid tumor type and is now approved to identify patients whose non-small cell lung cancer expresses the ROS1 genetic abnormality. ROS1 is a biomarker for locally advanced or metastatic NSCLC and is found in 1% to 2% of patients.
Roche's Rozlytrek is meant for patients who have the ROS1 genetic abnormality.
Chugai filed an application in March seeking approval for the indication. FoundationOne CDx was developed by Foundation Medicine Inc., which licensed the product to Roche, the parent of Chugai Pharmaceutical.
The diagnostic test was approved in Japan in 2018 and in the U.S. in 2017 for cancer diagnosis.