Genecast IVD Focus, a proprietary multi-gene mutation detection reagent kit used in NGS-based test for NSCLC and CRC. It utilizes amplicon-based targeted DNA and RNA NGS of FFPE tissue samples to determine mutations in EGFR, ALK, ROS1, KRAS, PIK3CA, BRAF, ERBB2 and MET genes. The detection of gene variants in the FFPE tissue samples provided by patients is followed by selection of the most effective targeted therapy for the patient.

We received a Class III medical device registration certificate from the NMPA for Genecast IVD Focus in February 2025. According to Frost & Sullivan, Genecast IVD Focus is the first commercially available mutation detection reagent kit in China approved for both NSCLC and CRC that enables simultaneous DNA and RNA-based testing.

Competitive Advantages

As an NMPA-approved companion diagnostic product that integrates both DNA and RNA NGS-based testing to support precision oncology decision-making, Genecast IVD Focus is the first IVD reagent kit in China approved for dual tumor types (NSCLC and CRC) and dual analytes (DNA + RNA), with companion diagnostic indications for nine targeted therapies, which is the broadest coverage among approved NGS panels as of the Latest Practicable Date. We believe Genecast IVD Focus has a number of potential advantages:

• Broad and actionable variant coverage. The panel includes eight cancer-relevant genes that are frequently mutated in NSCLC and CRC, covering clinically actionable biomarkers recommended in major treatment guidelines. It enables detection of key targets such as EGFR, ALK, ROS1, KRAS, NRAS, BRAF, ERBB2, and MET, supporting therapeutic decisions across multiple approved targeted therapies. This focused yet comprehensive design makes it an ideal front-line screening tool to identify patients who are likely to benefit from personalized treatment regimens, while also ensuring efficient use of limited clinical samples.

• Streamlined workflow with automation compatibility enables rapid report generation. Unlike traditional NGS panels that rely on paired-end sequencing, our proprietary multiplex amplicon-based platform adopts a patented bi-directional single-end sequencing approach. This innovative design captures reads from both the upstream and downstream primers in a single-end run, maintaining the accuracy and resolution of paired-end sequencing while halving sequencing time. The fully integrated workflow supports automation, minimizes hands-on time, and reduces contamination risks, allowing clinical laboratories to generate reports within 24 hours from FFPE sample receipt, ideal for timely clinical decision-making.

• Dual DNA+RNA profiling with validated performance. By integrating both DNA and RNA analysis, the test enables comprehensive detection of clinically actionable mutations, including SNVs, indels, and gene fusions. RNA-based fusion detection has been shown to offer superior sensitivity compared to DNA-based methods and is recommended in multiple clinical guidelines. The assay demonstrates robust analytical performance, with a limit of detection of 1% for SNVs/indels and 100 copies for gene fusions. Clinical validation studies have shown high concordance rates of over 99% for NSCLC and CRC, supporting its reliability in precision oncology applications.

• High sample efficiency with robust performance across variable sample quality. The assay requires minimal input of merely 10 ng of DNA and 50 ng of RNA, making it highly suitable for challenging specimens such as FFPE and fine-needle aspiration samples. To ensure accuracy even with degraded or low-input materials, we have developed a proprietary bioinformatics algorithm that effectively suppresses artifact signals caused by FFPE-induced DNA damage and technical noise from amplicon sequencing. This enables reliable variant calling across a broad spectrum of sample qualities, supporting consistent and accurate results in clinical settings and reinforcing its utility in therapy selection and precision oncology.