- Thermo Fisher Scientific said it has received expanded approval in Japan for its companion diagnostic test for non-small cell lung cancer (NSCLC) therapies.
- Japan’s Ministry of Health, Labour and Welfare granted approval to the test, called the Oncomine DX Target CDx system, to include three additional biomarkers for NSCLC.
- The companion diagnostic evaluates patient tumor samples for biomarkers associated with eight targeted therapies for NSCLC.
Precision medicine in which physicians tailor treatments based on a patient’s genetic profile is driving growth in companion diagnostics especially in the area of oncology. Thermo Fisher Scientific is among the companies focused on that opportunity. The Carlsbad, California-based company's specialty diagnostics segment alone last year saw revenue increase 7% to $3.72 billion.
Lung cancer is the most common form of cancer in the world, with 2.09 million cases globally in 2018, and the leading cause of death from cancer, according to the World Health Organization.
Thermo Fisher said the Oncomine Dx Target Test evaluates 46 cancer-driver gene variants at the same time, using 10 nanograms of DNA and RNA. The test received approval from Japan's regulatory body in April 2018 as a companion diagnostic to identify NSCLC patients who may benefit from therapies targeting the BRAF (V600E) mutation.
The expanded approval includes three additional biomarkers that have a total of eight associated targeted therapies for NSCLC patients. The markers and therapies are:
- 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
Thermo Fisher said its Oncomine test received national healthcare insurance reimbursement coverage in Japan in December 2018 for patients tested for the BRAF (V600E) gene mutation. The company expects the expanded markers on the test will receive reimbursement coverage in the coming months.