China's innovative cancer gene testing product, Shihe One, developed by Nanjing Shihe Gene Biotechnology Co., Ltd., receives FDA approval for market launch in the United States

On August 30, 2025, Beijing time, Nanjing Shihe Gene Biotechnology Co., Ltd. announced that its self-developed GENESEEQ PRIME® comprehensive pan-solid tumor high-throughput sequencing gene detection kit has officially received approval from the U.S. Food and Drug Administration (FDA) for marketing. This marks the first time that a large-panel, high-throughput sequencing in vitro diagnostic (IVD) kit independently developed by a Chinese domestic enterprise has successfully entered the core international market, and represents another milestone of innovation by Chinese private enterprises achieving global industry leadership.

Over the past decade, the field of precision diagnosis and treatment of cancer has developed rapidly, with a variety of new drugs emerging one after another. Along with this trend, the value of comprehensive genomic testing products in clinical applications and drug development has become increasingly prominent.

Gene+One® is a high-throughput sequencing large panel product capable of comprehensively detecting 425 genes associated with solid tumors and biomarkers related to immunotherapy. It simultaneously analyzes gene mutations, insertions and deletions, fusions, copy number variations, as well as key biomarkers such as microsatellite instability (MSI) and tumor mutation burden (TMB), providing a comprehensive genomic variation profile for dozens of solid tumors and rare cancers, including lung, colorectal, gastric, and breast cancers.

Previously, Shihe One® had obtained Class III medical device registration for tumor mutation burden (TMB) in lung cancer through the National Medical Products Administration (NMPA) of China under the innovative review pathway, and received CE marking in the European Union for all solid tumor indications. With this recent FDA approval, it has become the world's first and only large-panel NGS cancer test to simultaneously receive regulatory approval from the three major international authorities—NMPA, FDA, and CE—achieving a true "grand slam" and demonstrating China's innovative capabilities in the field of high-end medical devices.

As a pioneering in-house developed flagship product since the inception of Nanjing Shihe Gene Biotechnology Co., Ltd., Geneseeq One® has undergone multiple upgrades and extensive clinical validation. According to reports, Geneseeq One® underwent more than 10,000 performance verifications during its development phase, supporting the publication of nearly 400 SCI academic papers with a total impact factor exceeding 2,000. Its core performance metrics, including sensitivity, specificity, and reproducibility, have all reached internationally leading levels. During the U.S. clinical trial phase, over 1,500 clinical performance validations were conducted across multiple research centers in different states using real clinical samples, covering diverse ethnic populations. Study data indicate that its performance is significantly superior to that of currently marketed comparable products in the United States.

Moreover, unlike the single-lab testing model commonly used for most already marketed products in the United States, GenomeInsight® is provided in kit format, and its companion analysis software GENESIS® has been validated across multiple CLIA-certified laboratories in the U.S., demonstrating high usability, operational consistency, and result reliability in clinical settings, providing a solid foundation for the widespread adoption of GenomeInsight® in clinical testing laboratories.

The development of innovative drugs often involves international multi-center clinical trials (MRCT), including patient screening and enrollment, exploratory molecular target research, and multi-country regulatory registration. In addition, regulatory agencies commonly require companion diagnostics (CDx) to be developed in parallel with drugs to facilitate future compliance with medication use and insurance reimbursement. As an FDA-approved "off-the-shelf" standard kit, Shihe One® can be rapidly implemented across the United States and at Nanjing Shihe Gene Biotechnology Co., Ltd.'s CLIA/CAP laboratory in Toronto, eliminating the need for de novo validation of panels and targets during drug development, thereby effectively reducing MRCT costs and time. Using the same standardized testing method in both domestic and international clinical studies enhances cross-regional data interoperability and comparability, supporting simultaneous global market approval for new drugs. Meanwhile, the product's mature platform also lays the foundation for accelerating the development of overseas CDx.

Dr. Shao Yang, founder and chairman of Nanjing Shihe Gene Biotechnology Co., Ltd., said, "The cost of Shihe One® in China is less than one-third of that in the United States. We are proud to offer Chinese patients high-quality, cost-effective precision testing products." Currently, Shihe Gene is actively promoting the implementation of its product in partner laboratories across multiple locations in the United States. Moving forward, the company will fully initiate the process for Shihe One® to gain access to U.S. insurance reimbursement, enabling this innovative technology from China to better serve patients worldwide.