Illumina Comprehensive Genomic Profiling Test for Cancer Receives Regulatory Approval in Japan

Original from: Illumina

Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, announced today that it has received approval from the Ministry of Health, Labour and Welfare (MHLW) for TruSightTM Oncology (TSO) Comprehensive for Class III/IV Medical Device (Specially Controlled Medical Device) in Japan. As genomic insights continue to drive breakthroughs in cancer treatment, the test is designed to make precision oncology more accessible to oncologists and patients. 

This single test includes analysis of DNA and RNA variants and interrogates over 500 genes to profile a patient’s solid tumor, helping to increase the likelihood of identifying clinically actionable biomarkers that enable targeted therapy selection or clinical trial enrolment. This CGP test is powered by a streamlined, automated sample-to-report workflow, will enable clinicians in Japan to accelerate access to personalized medicine decisions with greater efficiency and precision. 

“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 is the first US FDA-approved, distributable comprehensive genomic profiling IVD kit with pan-cancer companion diagnostic claims in the US. 

Its separate CE-marked (Conformité Européenne) version of TSO Comprehensive was first launched in Europe in 2022.

“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,” Ohura said.

Illumina’s oncology portfolio adapts to global customer needs with versatile, scalable solutions—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 advances its oncology portfolio to drive progress in cancer diagnostics and precision medicine.

Illumina’s clinical oncology portfolio will be featured at the ASCO Annual Meeting in Chicago May 30-June 3.

Source: Illumina Comprehensive Genomic Profiling Test for Cancer Receives Regulatory Approval in Japan