Amoy Diagnostics Co Ltd (AmoyDx) has recently received approval from the Ministry of Health, Labor and Welfare of Japan for a polymerase chain reaction-based pan-lung cancer (PLC) panel for use as a companion diagnostic for RET fusion-positive non-small cell lung cancer (NSCLC), for selpercatinib 40 mg and 80 mg capsules. This is expected to expand the therapeutic options for patients and establish a new paradigm in the diagnosis and treatment of NSCLC in Japan, says GlobalData, a leading data, and analytics company.

GlobalData’s report, “PCR Systems Market Size (Value, Volume, ASP) by Segments, Share, Trend and SWOT Analysis, Regulatory and Reimbursement Landscape, Procedures, and Forecast, 2015-2033,” reveals that Japan’s PCR systems market is projected to grow at a compound annual growth rate of around 5% between 2023 and 2033.

Nandini Nagpal, Medical Devices Analyst at GlobalData, comments: “NSCLC is a major global health problem and the leading cause of cancer death worldwide. The current treatments only modestly improve survival and cause significant side effects. The limitations of the available NSCLC treatments in terms of efficacy and safety highlight the need for novel targeted therapies.”

AmoyDx claims that AmoyDx PLC Panel can simultaneously evaluate the presence of activation alterations in 11 driver genes (EGFR/ ALK/ ROS1/ KRAS/ BRAF/ HER2/ RET/ MET/ NTRK1/ NTRK2/ NTRK3 genes) when all genes on the panel are approved as companion diagnostics.

The panel has received approval for the identification of activating alterations in seven driver genes (EGFR, ALK, ROS1, BRAF, MET exon 14 skipping, KRAS, and RET) for 12 associated targeted therapies in NSCLC. With its high sensitivity and short turnaround time, it is expected to be an important clinical diagnostic in guiding the treatment opportunities for NSCLC patients.

Nagpal concludes: “The recent advances in oncology research have altered the treatment landscape for NSCLC. Early detection and improved treatment strategies are further essential for improving patient outcomes. As a result, the approval of AmoyDx PLC panel is anticipated to aid in the identification of targeted genes to expand patients’ treatment options.”