The CDx will be used to identify patients with ROS1-positive NSCLC, who may be eligible for treatment with entrectinib
New Thermo Fisher Scientific headquarters in Waltham. (Credit: Thermo Fisher Scientific Inc.)
Thermo Fisher Scientific has reached an agreement with Roche’s Japanese subsidiary Chugai Pharmaceutical to use a combined diagnostic (CDx) to identify a type of non-small cell lung cancer (NSCLC).
Also, the company has filed an application with Japan’s Ministry of Health, Labour and Welfare (MHLW) to expand the use of its Oncomine Dx Target Test in the country.
The CDx will be used to identify patients with ROS1-positive NSCLC, who may be eligible for treatment with entrectinib, developed by Genentech as Rozlytrek and marketed in Japan by Chugai.
Entrectinib is an MHLW approved treatment for ROS1-positive NSCLC adult patients and was previously granted US FDA accelerated approval, for ROS1-positive NSCLC in adult patients, and solid tumours with NTRK gene fusions in both adult and paediatric patients.
The CDx will identify patients with ROS1-positive non-small cell lung cancer (NSCLC)
The Japanese regulatory approval for the CDx is anticipated to enhance the access to Chugai’s targeted therapy through a locally administered, next-generation sequencing (NGS) biomarker test.
Oncomine Dx Target Test was previously approved in the US to identify ROS1-positive patients for treatment with crizotinib. The test is currently reimbursed by government and commercial insurers in the US, Europe, Japan and South Korea, covering more than 550 million people across the globe.
Furthermore, the test has been previously approved by the MHLW as a CDx for four biomarkers, dubbed EGFR, ALK, ROS1 and BRAF, which are associated with 12 targeted therapies for NSCLC.
Thermo Fisher clinical next-generation sequencing and oncology president Garret Hampton said: “Since receiving premarket approval for Oncomine Dx Target Test in 2017, Thermo Fisher has accelerated its endeavour to expand the use of comprehensive biomarker testing globally.
“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.”