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Thermo Fisher Scientific, Chugai Pharmaceutical Sign Companion Diagnostic Agreement for NSCLC

NEW YORK – Thermo Fisher Scientific said on Wednesday that it has a signed a companion diagnostic agreement with Chugai Pharmaceutical, a member of the Roche group.

In addition, Thermo Fisher has applied to the Ministry of Health, Labor, and Welfare of Japan to expand the use of the Oncomine Dx Target test in that country.

The two firms plan to use the CDx to identify ROS1-positive non-small cell lung cancer patients who may be eligible for treatment with entrectinib (Genentech's Rozlytrek, marketed in Japan by Chugai), and approval by the Japanese ministry would accelerate access to Chugai's targeted therapy through a locally administered sequencing biomarker test.

Entrectinib was approved in Japan in February to treat adult patients with ROS1-positive NSCLC. The drug also received accelerated approval by the US Food and Drug Administration in August 2019 to treat adult patients with ROS1-positive NSCLC, as well as both adult and pediatric patients with solid tumors that have NTRK gene fusions.

The Japanese ministry previously approved the Oncomine Dx Target test for four biomarkers – EGFR, ALK, ROS1 and BRAF – associated with 12 targeted therapies for NSCLC. The test was also previously approved in the US to identify ROS1-positive patients for treatment with crizotinib (Pfizer's Xalkori).

Last December, the Japanese ministry granted expanded approval for Foundation Medicine's FoundationOne CDx Cancer Genome Profile as a companion diagnostic for entrectinib for the detection of ROS1 fusion genes in patients with locally advanced or metastatic NSCLC. Foundation Medicine is a Roche subsidiary.

Thermo Fisher pointed out that unlike the FoundationOne CDx test, which is conducted outside of Japan, the Oncomine Dx Target test can be run locally, reducing the time to result to a few days.