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Thermo Fisher Scientific Oncomine Dx Target Test Gets Expanded Regulatory Approval in Japan

NEW YORK (GenomeWeb) – Thermo Fisher Scientific said today that Japan's Ministry of Health, Labor, and Welfare has granted expanded approval to its Oncomine Dx Target Test CDx System.

The next-generation sequencing test detects 46 cancer-driver gene variants associated with approved and investigational targeted therapies for solid tumors — including EGFR, BRAF, KRAS, and ERBB2 mutations, and ALK, ROS1, RET, NTRK, and MET fusions. It is also validated as a companion diagnostic for certain approved non-small cell lung cancer therapies including ALK, ROS1, and BRAF kinase inhibitors, as well as EGFR exon 19 deletions and L858R tyrosine kinase inhibitors.

The MHLW's newly expanded approval follows an initial endorsement of the test in April 2018 to identify NSCLC patients who may benefit from therapies targeting the BRAF (V600E) mutation.

In its expanded decision, the regulatory agency has now approved the test for measuring three additional biomarkers: EGFR exon 19 deletion mutations and EGFR exon 21 L858R mutations to guide the use of afatinib, gefitinib, erlotinib, and osimertinib; ALK fusions for alectinib and crizotinib; and ROS1 fusions also for crizotinib.

As of December 2018, the test had won a reimbursement coverage decision for the BRAF mutation indication in Japan and Thermo Fisher said it anticipates the newly approved markers will also receive coverage in coming months.

Oncomine Dx was approved as a NSCLC companion diagnostic by the US Food and Drug Administration in mid-2017. It is currently offered by several national reference laboratories and has received positive coverage decisions from the Centers for Medicare & Medicaid Services and from private payors.

Thermo also received a CE-IVD mark for the assay last October.