The first pan-cancer companion diagnostic in vitro diagnostic kit is approved in the United States

On August 27, 2024 local time, Illumina, a well-known gene sequencing enterprise in the United States, issued a major announcement. Its in vitro diagnostic product (IVD) - TruSight Oncology Comprehensive detection kit and its two companion diagnostic indications were successfully approved by the US Food and Drug Administration (FDA). Illumina claims that this is the first genome in vitro diagnostic kit for pan-cancer companion diagnosis approved by the FDA, which is of milestone significance.

TSO Comprehensive is an advanced in vitro diagnostic test product. Using the Illumina NextSeq 550Dx instrument, nucleic acids are extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue samples of cancer patients with solid malignancies. Through targeted next-generation sequencing methods, it can detect variations in 517 cancer-related genes of nearly 30 types of solid tumors. A version of this kit was launched in Europe in 2022.

Among them, NTRK and RET fusions are two genetic changes supported by this test, which makes this in vitro diagnostic reagent can be used as a companion diagnostic method for two cancer drugs, Bayer's Vitrakvi (for *** and child patients with solid tumors with NTRK mutations) and Eli Lilly's Retevmo (for patients with RET fusion-positive non-small cell lung cancer).

It is worth mentioning that Vitrakvi is one of the first batch of pan-cancer therapy drugs and was approved by the FDA in 2018. However, the probability of NTRK gene fusion being found in solid tumors is only about 0.1% to 0.3%, and it is difficult to detect. Bayer has difficulty in finding patients suitable for targeted therapy. The approval of the NTRK companion diagnostic kit of the TSO Comprehensive test product for various solid tumor indications this time helps to obtain the maximum amount of information available for clinical intervention from each patient sample. Compared with the approved version in the European Union, Retevmo is the new test content of the American version of the TSO Comprehensive kit.

Illumina said it is developing more companion diagnostic applications and will be added to this test product after obtaining regulatory approval in the future. In addition, TSO Comprehensive was included in Taiwan region of China's National Health Insurance system on May 1, 2024, becoming the "pioneer" of companion diagnostic solutions entering the health insurance system in Asia. According to estimates by Zhiyan Consulting, the global companion diagnostic market size will reach 14.69 billion US dollars in 2025. In 2019, the market size of China's companion diagnosis has reached 2.72 billion yuan. Estimated at a growth rate of 33.3%, it will reach 15.26 billion yuan in 2025. The approval of this kit will undoubtedly bring new opportunities and broad prospects for precision cancer medicine.