Nanjing Shihe Gene Biotechnology Co., Ltd., a leading IVD enterprise, has received FDA approval for its blockbuster product
BeijingAugust 30, 2025, marked another milestone for Shihe Gene in China's precision oncology field—the independent development of Shihe No. ®（GENESEEQPRIME®）High-throughput sequencing for pan-solidThe NGS large-panel genetic testing kit has officially received approval from the U.S. Food and Drug Administration (FDA) for marketThis is the follow-up toShihe No. 1 in October 202®BigFollowing its approval through the National Medical Products Administration's special review channel for innovative medical devices, the Panel TMB kit from Nanjing Shihe Gene Biotechnology Co., Ltd. has once again gained recognition from authoritative regulatory agencies
HighPanel kits can truly leverage their advantages of high throughput and comprehensive detection. However, due to their high technological complexity, rigorous validation requirements, and substantial R&D investment, they have always been regarded as the crown jewel of the IVDThe approvedGENESEEQPRIME®Product, comprehensive detection of solid tumorsPoint mutations and insertions-deletions of 425 genes, along with fusions and copy number variations of related driver genes, as well as key biomarkers such as microsatellite instability (MSI) and tumor mutational burden (TMB), provide a comprehensive genomic variation profile for dozens of solid tumors including lung cancer, colorectal cancer, gastric cancer, breast cancer, as well as rare cancer types.
Shihe No. 1®The approval marks a significant milestone for China's domestic highPanel IVD diagnostic reagents have successfully entered the international core market for the first time, marking another milestone where a Chinese private enterprise's innovation has become a global industry benchmark.At this point, Shihe No. ®Becoming the first and only globally to receive approval from China's National Medical Products Administration and the UNanjing Shihe Gene Biotechnology Co., Ltd.'s NGS large-panel tumor genetic testing product, triple-certified by the FDA and the EU CE, truly lives up to its reputation as the "Pride of China" in the precision medicine industry
Break barriers, global
China's innovation power opens international channel for precision
Over the past decade, the field of precision cancer diagnosis and treatment has advanced rapidly, with a variety of new drugs emerging one after another. Alongside this trend, the value of comprehensive genomic profiling products has become increasingly prominent in both clinical applications and drug
Shihe No. 1®Since its inception, it has been an innovative flagship product independently developed by Shihe Gene, undergoing several upgrades and standing the test of clinical practice. Based on Shihe®, the company's team has collectively participated in the publication of nearlyWith over 400 academic papers and a total impact factor exceeding 2000, the research covers dozens of cancer types and clinical scenarios including lung cancer, colorectal cancer, gastric cancer, and breast cancer. Collaborating with clinical and academic experts, pharmaceutical companies, and industry partners, we have jointly advanced the development of precision medicine in China
▶October 2023:Based on Shihe One®The "Non-Small Cell Lung Cancer Tissue TMB Testing Kit" (425-gene Panel), developed by Nanjing Shihe Gene Biotechnology Co., Ltd., was approved for market release through the National Medical Products Administration’s special review channel for innovative medical devices. This followed rigorous clinical validation involving over a thousand samples, which demonstrated high standards in assessing TMB, high-frequency genetic variations, and pharmacodynamic correlations. It is China’s first approved large-panel NGS kit for tumor
▶In August of the same year,Shihe One®Already with425 Gene Solid Tumor Indication Receives EU CE Certification.
▶August 2025:After five years of relentless effort by the R&D team, Shihe No. 1®In the United StatesFDA approved for marketing,Covering solid425 gene point mutations and insertions/deletions, fusions and copy number variations of related driver genes, MSI and T, becoming the only tumor with full certification in China, the United States, and EuropeNGS large Panel
Shihe No. 1®With outstanding clinical performance and comprehensive target coverage, it has been highly recognized by numerous commercial clinical testing laboratories worldwide. Currently, Shihe Gene is actively promoting the implementation of its products in cooperative laboratories across multiple locations in the United States. Following the recent product launch inFDA officially approved, the company will fully launch Shihe No. 1.®U.S. Medicare access, looking forward to the early promotion of products in the international“Acceleration.”
Fully validated, excellent
Let"Chinese Standards" Lead the Way in "World Standards"
Shihe One®The kit underwent over ten thousand performance validations during the R&D phase, targeting point mutations (SNV), insertions and deletions, gene fusions, copy number variations, and biomarkers such as MSI and TMB. Key performance indicators including detection sensitivity, specificity, and reproducibility have reached internationally leading levels.In the U.S. clinical trial phase, clinical performance validation was conducted using real clinical samples across multiple state research centers.15,000 participants, covering all ethnic groups. Compared with similar products already on the market in the United States, Shihe-®Outstanding performance, leading the way in capabilities：Within the 425-gene range, the average limit of detection (LoD) for hotspot SNVs was 2.14%, as low as 0.90%; the average LoD for non-hotspot SNVs was 2.95%, as low as 2.03%; the average LoD for insertion mutations was 2.82%, as low as 0.93%; the average LoD for deletion mutations was 5.32%, as low as 0.78%. The concordance between MSI and dMMR-IHC reached 97.5%, with 100% consistency between colorectal and endometrial cancer results and IHC findings. The concordance between TMB and WES-TMB reached 0.93.
Meanwhile, Shihe No. 1®MGENESIS®AnalysisTumor only Sequencing （ToSeq）Machine learning module, using a random forest model, recentlyAfter training and validation on a large sample set of 8,000 cases, the AUC for excluding germline mutations exceeded 0.98, significantly reducing background noise from germline mutations. The performance of testing tumor samples alone was comparable to that of paired testing with healthy cells, far surpassing that of similar products in the United
Moreover, unlike the single-laboratory定点检测模式 adopted by most approved products in the United States, Shihe一号®In the form of a kit. This significantly enhances the product's accessibility and operational flexibility on one hand, while on the other hand, itThe FDA has set higher requirements for the product.On the basis of rigorously verifying the stability and inter-batch repeatability of the testing kit during the R&D phase, Shihe-®Using clinical samples, a series of reproducibility validations including inter-operator, inter-day, and inter-instrument comparisons were successfully completed across multiple centers in the United States.GENESIS®The software is also used in numerousCLIA laboratory completed human factors engineering validation, involving dozens of real users, including molecular testing technicians, pathology experts, and bioinformatics analysts. Under clinical usage scenarios, it demonstrated high usability, operational consistency, and result reliability for Shihe-®The widespread application in the clinical laboratory provides a solid guarantee. Shihe One®The clinical robustness of the test kit, coupled with the user-friendliness and cybersecurity of its supporting software, has successfully demonstratedFDA certification: The product fully meets the rigorous review standards set by U.S. regulatory authorities for IVD in kit
Deep Empowerment, Win-Win Cooperation
Globalization strategy for“Catalyst”
The development of innovative drugs often involves international multi-center clinical studiesMRCT) patient screening and enrollment, exploratory molecular biomarker research, and multi-country registration, among others. In addition, regulatory authorities generally require the synchronized development of companion diagnostics (CDx) with drugs to facilitate future compliant medication use and insurance reimbursement. With its vast population base and continuously advancing research and development capabilities, China has become a significant market that cannot be overlooked in the global landscape of innovative drug development. Currently, China accounts for over 30% of the world's investigational innovativeAtIn MRCTs, when the detection methods (CTAs) used by central laboratories in different countries are not uniform, pharmaceutical companies often need to invest significant resources in validating different CTAs, conducting cross-laboratory consistency comparisons, and separately developing multiple CDx assays. Additionally, inconsistencies in methodological standards may lead to data incomparability, which inadvertently increases the cost of new drug development. Genec®InFDA approval offers a superior solution to this series of pain
Standard Process• Global Rapid ImplementationShihe No. 1®AsThe FDA-approved "ready-to-use" product offers a better cost-performance ratio than its U.S. counterparts. It can be rapidly implemented across the United States and at Shihe Gene's Toronto CLIA/CAP laboratory, eliminating the need for de novo validation of panels and targets, effectively reducing the cost and time required for MRCT.
Same-F· Overcoming MRCT barriersClinical studies both in China and internationally adopt the sameEmploying the CTA testing method for enrollment screening and exploratory research can establish consistency in testing standards and other aspects, effectively enhancing the interoperability and comparability of cross-regional data, thereby facilitating the simultaneous approval of new drugs in global core markets.
Accelerate the Development of Overseas Companion Diagnostics:Shihe No. 1®The product is fully finalized,During the FDA registration process, the reagent system, full range of panels, and validation of numerous common targets have been completed. This allows for the rapid and convenient development of U.S. CDx through co-development or bridging approaches on the existing foundation, addressing the disconnect between CTA and CD
—Conclusion—
Having experiencedAfter a decade of refining technology and undergoing clinical trials with hundreds of thousands of samples, Shihe-®AtThe FDA approval not only represents a significant international regulatory endorsement of its outstanding performance but also showcases the comprehensive strength of Chinese private enterprises in innovative R&D, international expansion, and global compliance. It sets a benchmark for high-tech, high-value Chinese medical products to enter core global markets.Dr. Shao Yang, Founder and Chairman of Shihe Gene, stated"This is a significant milestone in Shihe Gene's journey towards internationalization and a shared pride for China's precision medicine industry. We will take this opportunity to further deepen our collaboration with global pharmaceutical companies, medical institutions, and research organizations, striving to make precision medicine transcend borders and ensure that innovative technologies originating from China better serve patients worldwide. At the same time, the Shihe One®Priced at less than one-third of that in the United States, we are deeply proud to provide high-quality, cost-effective precision testing products for Chinese patients.”