In Vitro Diagnostic Industry in China - Molecular Diagnosis Analyzers and Reagents XVII

3.3 Tumor Companion Diagnostic Reagents

Non-small Cell Lung Cancer Companion Diagnostic Tests

High-throughput sequencing (HTS) has started to be applied in tumor companion diagnosis in recent years. NMPA approved two test kits based on HTS in 2020. Human EGFR/KRAS/BRAF/HER-2/ALK/ROS1 Gene Mutation Detection Kit (Semiconductor Sequencing Method) (Registration No.: G.X.Z.Z. 20,203,400,094) of Xiamen Spacegen Co., Ltd. (“Spacegen”) uses a PCR platform combining specific modified primers and RingCap® Ring-Link Capture Library technology (Patent No.: 201510496049.5) for library construction. Compared to other targeted sequencing library preparation, RingCap® technology simplifies the manual process with two steps of sample-adding and two steps of purification in 3.5 h.

The other test is the Eight-Gene Mutations Screening Kit (Semiconductor Sequencing Method) (Registration No.: G.X.Z.Z. 20,203,400,072) of Beijing Genetron Holdings Limited. It is based on the “One-Step Method” technology (Patent No.: 201710218529.4), which contains target-specific sequences, junction, and label on a pair of primers, and completes the steps of specific fragment amplification, the addition of junction, and the addition of label in one step of PCR amplification. Compared to the traditional “two-step” method, one amplification and one purification step are reduced. As a result, the total time for library construction and manual operation is reduced.

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