Illumina, Inc. (NASDAQ: ILMN) announced on May 27, 2025, that it has received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for TruSight Oncology (TSO) Comprehensive as a Class III/IV Medical Device (Specially Controlled Medical Device). This regulatory milestone is expected to significantly expand access to precision oncology options for cancer patients in Japan.
Comprehensive Genomic Profiling Technology
The TruSight Oncology Comprehensive test represents a significant advancement in cancer diagnostics, utilizing a single assay to analyze both DNA and RNA variants across over 500 genes to profile solid tumors. This comprehensive approach increases the likelihood of identifying clinically actionable biomarkers that can guide targeted therapy selection or enable clinical trial enrollment.
The test employs a streamlined, automated sample-to-report workflow designed to help clinicians accelerate access to personalized medicine decisions with greater efficiency and precision. As a comprehensive genomic profiling approach, it uses next-generation sequencing to assess hundreds of genes, including relevant cancer biomarkers established in guidelines and clinical trials, for therapy guidance.
Clinical Impact and Market Position
"Genomics helps bring precision medicine to life as it enables clinicians to match available treatments to a patient's genetic tumor profile, which has the potential to improve cancer treatment and quality of life for patients," said Catherine Ohura, General Manager at Illumina Japan. "We look forward to bringing this genomic profiling test to Japan, improving access to precision medicine solutions for cancer patients."
TruSight Oncology Comprehensive holds the distinction of being the first US FDA-approved, distributable comprehensive genomic profiling IVD kit with pan-cancer companion diagnostic claims. The test's separate CE-marked version was first launched in Europe in 2022, demonstrating Illumina's global expansion strategy for precision oncology solutions.
Strategic Vision for Japanese Market
Ohura emphasized the broader implications of genomic medicine in cancer care, stating, "Cancer is a disease of the genome, and we know that genomic insights from next-generation sequencing can lead to better oncology outcomes. We are committed to working with government, patients, and the medical community to bring attention to the need for ongoing investment in education and infrastructure needed in Japan to integrate genomics as a standard part of care in the fight against cancer."
Expanding Oncology Portfolio
Illumina's oncology portfolio is designed to adapt to global customer needs with versatile, scalable solutions ranging from low- to high-throughput instruments. Through pharmaceutical partnerships, the company is developing an expanding pipeline of companion diagnostics (CDx). By collaborating with industry leaders, Illumina continues to advance its oncology portfolio to drive progress in cancer diagnostics and precision medicine.
The company's clinical oncology portfolio will be featured at the upcoming ASCO Annual Meeting in Chicago from May 30 to June 3, highlighting the continued focus on advancing precision oncology solutions globally.
