Thermo Fisher Scientific announced that the Ministry of Health, Labour and Welfare (MHLW), Japan's regulatory agency, has granted expanded approval to the Oncomine Dx Target Test CDx System.
The next-generation sequencing (NGS)-based multiplex companion diagnostic (CDx) test simultaneously evaluates patient tumor samples for biomarkers associated with targeted therapies for non-small cell lung cancer (NSCLC).
Oncomine Dx Target Test simultaneously evaluates 46 cancer-driver gene variants using as little as 10 nanograms of DNA and RNA. Following the April 2018 approval of the test in Japan as a CDx to identify NSCLC patients who may benefit from therapies targeting the BRAF (V600E) mutation, the MHLW today expanded its approval to include three additional biomarkers with a total of eight associated targeted therapies for NSCLC patients. The CDx markers and therapies include:
EGFR exon 19 deletion mutation and EGFR exon 21 L858R mutation – afatinib, gefitinib, erlotinib, osimertinib
ALK fusion gene – alectinib, crizotinib
ROS 1 fusion gene – crizotinib
BRAF V600E mutation – Combined therapy of dabrafenib and trametinib (approved April 2018)
Oncomine Dx Target Test received national healthcare insurance reimbursement coverage in December 2018 for patients tested for the BRAF (V600E) gene mutation in Japan. Thermo Fisher anticipates the expanded markers on the test will also receive reimbursement coverage in the coming months.
“We are grateful to the MHLW and the Pharmaceuticals and Medical Devices Agency for expediting its approval of Oncomine Dx Target Test, and to our regional partner who collaborated with us on local clinical studies that led to this latest milestone,” said Joydeep Goswami, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. “Thanks to this collaborative effort, patients in Japan now have direct access to the first-and-only, locally administered NGS-based test that covers all four companion diagnostic biomarkers and targeted therapies associated with non-small cell lung cancer.”
Source: Company Press Release