Zhenhe Biotech's First-in-China DNA & RNA Dual-Assay Companion Diagnostic Kit Approved by NMPA

On February 26, 2025, the National Medical Products Administration (NMPA) approved Genecast’s “Human 8-Gene Mutation Combined Detection Kit (Reversible Terminator Sequencing Method)” for market launch. This kit can be used for in vitro detection in patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).EGFR, ALK, ROS1, KRAS, PIK3CA, BRAF, ERBB2, and MET exon 14 skipping mutations.Notably,This kit is the first approved in ChinaDNA&Dual RNA Testing、Simultaneously meeting the criteria for both non-small cell lung cancer and colorectal cancerCompanion Diagnostic Products, or it may become the preferred choice for patients' initial testing.

The clinical validation of this kit spanned three years, involving nearly 3,000 clinical samples across eight centers. In comparative studies against Sanger sequencing (the gold standard), the overall concordance rate exceeded 99%. The limit of detection (LOD) for SNVs/Indels was as low as 1%, and the LOD for fusions was 100 copies/50 ng.

Leveraging its robust R&D capabilities, this kit has successfully achieved a breakthrough in China’s NGS companion diagnostic kit sector, ending a six-year stagnation. This milestone achievement not only fills several gaps in the field of companion diagnostics but also marks significant technological progress and innovation in domestic tumor NGS genetic testing, representing a solid and crucial step forward.

Given current medical diagnostic practices, the essential genetic testing items for the vast majority of cancer patients are no longer limited tolimited to a single gene. This kit can simultaneously detect multiple tumor-associated genes. The approved companion diagnostic applications cover various mutation types, including SNVs, INDELs, and fusions, enabling physicians to gain a more comprehensive understanding of the patient’s condition and formulate more precise treatment plans. This holds significant importance for improving survival rates and quality of life in cancer patients.Moreover,This kit is indicated for the companion diagnosis of nine anti-tumor drugs, representing the largest number of companion diagnostic drugs covered among currently approved products in China.Among them, for NSCLC, EGFR exon 19 deletion (19Del) and L858R point mutation are used for Gefitinib Tablets, hydrochlorideCompanion diagnostic testing for Icotinib Tablets, Osimertinib Mesylate Tablets, Afatinib Maleate Tablets, and Erlotinib Hydrochloride Tablets; EGFR gene T790M point mutation is used for companion diagnostic testing of Osimertinib Mesylate Tablets; ALK gene rearrangement (fusion) and ROS1 gene rearrangement (fusion) are used for companion diagnostic testing of Crizotinib Capsules; MET gene exon 14 skipping mutation is used for companion diagnostic testing of Glumetinib Tablets and Tepotinib Hydrochloride Tablets. For CRC, KRAS gene wild-type status is used for companion diagnostic testing of Cetuximab Injection.

The kit features a simple and clear procedure.Easy to operate, with a core process involving only two amplification steps, enabling even novice researchers to quickly master the technique.This kit enables the entire process, from sample extraction to report generation, to be completed in just24 Hours, and there is no need to replace the reaction tube throughout the entire process. On one hand, accelerating the testing cycle helps physicians formulate personalized diagnosis and treatment plans for patients as soon as possible, thereby more effectively controlling disease progression and securing a critical therapeutic advantage for patients; on the otherOn the one hand, it also helps alleviate the workload of pathology departments, thereby enhancing the efficiency and quality of overall medical services.

Given the diversity and complexity of genetic variants in real-world settings, a single detection method is insufficient to cover all variations. DNA testing demonstrates sensitivity comparable to capture-based methods in identifying hotspot mutations, while RNA-level testing exhibits higher sensitivity in detecting gene fusions. Therefore, simultaneous DNA and RNA testing can significantly enhance the comprehensive detection capability for multiple variant types. Previously, combined DNA and RNA next-generation sequencing (NGS) testing typically employed sequential or parallel approaches, involving separate extraction, library preparation, and sequencing of DNA and RNA from tumor samples, which not only resulted in high testing costsMoreover, it increases sample requirements and extends the testing cycle, thereby limiting its widespread application.The newly approved innovative test kit has achievedCombined NGS detection of DNA and RNA not only providesRNAThe detection efficiency at the panel level maintains the same sample requirements and turnaround time as single-gene testing, while significantly enhancing clinical convenience and securing more valuable opportunities for targeted therapy for patients.。

Given the extreme preciousness of clinical samples, this kit employs a multiplex amplification method, requiring only 10 ng of DNA and RNA respectively, thereby significantly reducing sample requirements. Furthermore, it enables the simultaneous detection of multiple genes and their various mutation types in a single reaction. Compared to qPCR products, this approach not only conserves valuable sample resources but also substantially lowers testing costs. In addition, the kit has minimal laboratory space requirements, as operations rely primarily on a single PCR instrument, eliminating the need for additional equipment such as ultrasonicators and vacuum concentrators, thus simplifying the experimental workflow. Most importantly, the kit effectively improves amplification uniformity through its core technology, requiring relatively less data output, which further reduces sequencing costs and makes NGS testing more cost-effective and efficient.

Prior to this, Genecast already possessed China’s first NGS companion diagnostic kit specifically focused on colorectal cancer. This latest approval will further strengthen the company’s capabilities in companion diagnostics for lung cancer, once again demonstrating Genecast’s exceptional strength and relentless pursuit in expanding both the depth and breadth of its oncology drug companion diagnostic portfolio.

In fact, as early as 2022, the test kit had already taken the lead in obtaining EU CE certification. The recent successful approval by the NMPA has added the solid guarantee of “dual certification,” marking another significant milestone in Genecast’s layout in the field of precision oncology diagnostics. Coupled with the recent official recognition of the company’s newly launched gene sequencer, Genecast has consecutively secured two crucial strongholds on its strategic chessboard for precision oncology diagnostics, once again demonstrating to the outside world its profound accumulation and strong development momentum in the field of precision diagnostics. Moving forward, Genecast will leverage its technological advantages and integrate them with clinical practice to launch diagnostic products that meet diverse clinical needs, thereby helping the precision medicine industry reach new heights.