CARLSBAD, Calif., June 3, 2019 /PRNewswire/ -- Thermo Fisher Scientific today announced that its Oncomine Dx Target Test CDx System has received reimbursement coverage from Japan's Ministry of Health, Labour and Welfare and is now commercially available in that country. The next-generation sequencing (NGS)-based companion diagnostic (CDx) test evaluates patient tumor samples for multiple biomarkers associated with targeted therapies for non-small cell lung cancer (NSCLC).
Japanese cancer patients now have access to a reimbursed NGS test designed to detect multiple key driver genes simultaneously in NSCLC to more quickly determine if they are candidates for one of eight targeted therapies. The CDx biomarkers 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
Tumor samples retrieved from NSCLC patients are often limited in quantity, which can pose challenges in the lab. The Oncomine Dx Target Test leverages Thermo Fisher's Ion AmpliSeq technology to overcome this hurdle, enabling testing results to be returned to oncologists using very small amounts of biopsied tumor samples. This reduces the potential for risky second biopsies and unnecessary physical burden to patients.
As an approved CDx system, Oncomine Dx Target Test can now be applied upfront at the initial diagnostic treatment stage for all NSCLC patients in Japan. Since there is no approval condition for the facility requirements, it can be used in all medical facilities where cancer treatment is performed.
"We are very pleased to offer clinicians and their patients the Oncomine Dx Target Test in Japan," said Joydeep Goswami, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "Their ability to access our reimbursable, multibiomarker companion diagnostic, and have the test performed locally, is a true milestone that will help accelerate the process of selecting the most appropriate targeted therapy for non-small cell lung cancer patients."
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of more than $24 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services. For more information, please visit www.thermofisher.com.
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