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

3. Molecular Diagnostic Reagents for Tumor

3.1 Tumor Screening Reagents

Colorectal Cancer Screening Test

The U.S. Preventive Services Task Force (USPSTF) recommends four types of screening for cancers: lung cancer, colorectal cancer, breast cancer, and cervical cancer. All screening methods are based on imaging tests, except for cervical cancer, which can be screened by using the human papillomavirus (HPV) molecular diagnostic method. In November 2020, NMPA approved the KRAS Gene Mutation BMP3/NDRG4 Methylation and Stool Occult Blood Combination Test Kit (PCR-Fluorescence - Colloidal Gold method) (Registration No.: G.X.Z.Z 20203400845) of Shenzhen New Horizon Health Ltd., which is a colorectal cancer screening kit based on fluorescent PCR and colloidal gold technology. The kit detects KRAS gene mutations (including G12D, G12A, G12V, G12S, G12R, G12C, and G13D), BMP3, and NDRG4 gene methylation and hemoglobin in human stool samples in vitro. The test values will be calculated by KRAS Gene Mutation, BMP3/NDRG4 Gene Methylation, and Stool Occult Blood Combination Analysis Software (Registration No.: Z.X.Z.Z 20202210848) and used for the screening of colorectal cancer high-risk group (40–74 years old) with poor colonoscopy compliance.

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