Thermo Fisher, Chugai Pharmaceutical Enter Companion Diagnostic Agreement

Thermo Fisher Scientific has signed a companion diagnostic (CDx) agreement with Chugai Pharmaceutical, a member of the Roche Group, and has applied to the Ministry of Health, Labour and Welfare (MHLW) to expand the use of the Oncomine Dx Target Test in Japan. The CDx will be leveraged to identify ROS1-positive non-small cell lung cancer (NSCLC) patients who may be eligible for treatment with entrectinib (Rozlytrek). Approval by the MHLW would accelerate access to Chugai's targeted therapy via a locally administered, next-generation sequencing (NGS) biomarker test.

Entrectinib received MHLW approval in February 2020 to treat ROS1-positive NSCLC adult patients. Prior to that, the drug received accelerated approval by the U.S. Food and Drug Administration (FDA) in August 2019 to treat ROS1-positive NSCLC adult patients, and both adult and pediatric patients with solid tumors that have NTRK gene fusions. ROS1 gene fusions are prevalent in 1-2 percent of NSCLC cases. It is one of 46 cancer-related biomarkers evaluated by the MHLW-approved version of Thermo Fisher's Oncomine Dx Target Test. The MHLW previously approved the test as a CDx for four biomarkers – EGFR, ALK, ROS1 and BRAF – associated with 12 targeted therapies for NSCLC. The test was previously approved to identify ROS1-postitive patients for treatment with crizotinib in the U.S.

Oncomine Dx Target Test is currently reimbursed by government and commercial insurers in the U.S., Europe, Japan and South Korea, covering more than 550 million lives globally. Lung cancer is the leading cause of cancer deaths worldwide, and each year the disease causes more than 1.6 million deaths - more than breast, colon and prostate cancers combined. In Japan, lung cancer is the leading cause of cancer deaths in men, making up about 25 percent of all male cancer deaths in 2015.

"Since receiving premarket approval for Oncomine Dx Target Test in 2017, Thermo Fisher has accelerated its endeavor to expand the use of comprehensive biomarker testing globally," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher. "Our latest agreement underscores this commitment to build on the Oncomine Dx Target Test, which is still the first-and-only approved NGS companion diagnostic in Japan that is administered locally to expedite patient testing in the region."