From January 15th to 23rd, the NMPA approved the registration of a total of 20 IVD products, including 13 domestic IVD products and 7 overseas IVD products.
There are three products in this batch as the "first": the "Human Exosome CA125, HE4, C5A Detection Kit (Chemiluminescence Method)", the "Human APOE Genotyping Detection Kit (PCR-Fluorescent Probe Method)" and the "Human CYP2D6 Genotyping Detection Kit (PCR-Fluorescent Probe Method)" of Daan Gene.
As one of the common methods of liquid biopsy, exosomes have been deployed by many companies in this field, and the fastest certification process is the approved product "Human Exosome CA125, HE4, C5A Detection Kit (Chemiluminescence Method)" (trade name: ExosomeTM), according to official reports, on February 7, 2022, the Instrument Review Center issued a notice on the announcement of the review results of the application for priority approval of medical devices. The "Exosomal Ovarian Cancer Auxiliary Diagnostic Kit (Chemiluminescence Method)" of Shanghai Sidi Biomedical Technology Co., Ltd. is proposed to be given priority approval, and the product is "a medical device that is urgently needed in clinical practice and has not yet been approved for registration of the same variety of products in China".
Clinical data showed that the overall sensitivity of "PrimusTM" in the diagnosis of ovarian cancer was 95 by measuring the biomarker combination in human serum exosomes in vitro5%, with a specificity of 90 in the differential diagnosis of epithelial ovarian cancer and adnexal benign masses2%, with a sensitivity of 89 for diagnosis in stage I ovarian cancer9%, which is higher than the sensitivity of traditional single serum CA125 detection (27.)8-64.3%）。
The registration application of "Human APOE Genotyping Detection Kit (PCR-Fluorescent Probe Method)" (National Machinery Note 20243400073) of Guangzhou Daan Gene Co., Ltd. was successfully approved. The kit is based on accurate and accessible fluorescent PCR technology, which mainly targets the single nucleotide polymorphisms of APOE gene 388T>C and 526C>T loci in genomic DNA of human whole blood samples. It can detect nucleic acids from 1-100 ng l; At the same time, the relevant anti-pollution components are added, which in turn reduces the contamination caused by PCR products. APOE genotyping test provides a basis for the rational and effective use of statins in clinical practice; It can also provide a reference for the causes of related diseases such as hyperlipidemia, coronary heart disease, Alzheimer's disease, etc., and then carry out healthy life management (review report reference: [Review Report] Daan Gene - the first IVD of the same variety).
The registration application of "Human CYP2D6 Genotyping Detection Kit (PCR-Fluorescent Probe Method)" (National Machinery Note 20243400076) was successfully approved. The kit targets the polymorphism of the C688T (*10) locus of the CYP2D6 gene in the genomic DNA of human whole blood samples; It can detect nucleic acids from 1-100 ng l; At the same time, the relevant anti-pollution components are added, which in turn reduces the contamination caused by PCR products. Clinically, the drug regimen and dose can be adjusted with reference to the CYP2D6 genotype (review report reference: [Review Report] Human CYP2D6 Genotyping Detection Kit (PCR-fluorescent probe method).
The details are as follows:
Shanghai Sidi Biomedical Science and Technology Co., Ltd. Product Name: Human Exosome CA125, HE4, C5A Detection Kit (Chemiluminescence Method) National Machinery Note: 20243400138
Approval Date: 2024-01-18
Zhengzhou Antu Bioengineering Co., Ltd. *** Product Name: Human ALDH2 Gene Detection Kit (PCR-Fluorescent Probe Method) National Machinery Note: 20243400144 Approval Date: 2024-01-18
Guangzhou Maijing Gene Medical Science and Technology***Product Name: Human KRAS Gene Mutation Detection Kit (Fluorescent PCR Method) National Machinery Approval: 20243400145 Approval Date: 2024-01-18
Shenzhen Mindray Biomedical Electronics Co., Ltd.***Product Name: Toxoplasma gondii IgG Antibody Detection Kit (Chemiluminescence Immunoassay Method) National Machinery Note: 20243400139 Approval Date: 2024-01-18
Suzhou Kangji Diagnostic Reagent***Product Name: Human CYP2C19 Genotyping Detection Kit (PCR-Fluorescent Probe Method) National Machinery Approval: 20243400149 Approval Date: 2024-01-18
Jidan Biotechnology Co., Ltd.*** Product Name: Human Papillomavirus (HPV) Nucleic Acid Detection and 16 18 Typing Kit (Fluorescent PCR Method) National Machinery Note: 20243400146 Approval Date: 2024-01-18
Roche Diagnostics Products (Shanghai)**Product Name: Murine Monoclonal Negative Sexually Controlled Antibody National Machinery Injection: 20243400049 Approval Date: 2024-01-18
Roche Diagnostics Products (Shanghai)**Product Name: 2-Microsphere Protein Control National Machinery Injection: 20242400047 Approval Date: 2024-01-18
Roche Diagnostics (Shanghai)**Product Name: 2-Microglobulin Calibrator National Machinery Injection: 20242400046 Approval Date: 2024-01-18
Siemens Medical Diagnostics Products (Shanghai)**Product Name: Multiple Protein Controls (Level 1) National Machinery Injection: 20242400045 Approval Date: 2024-01-18
Suzhou Xinhai Biotechnology Co., Ltd. *** Product Name: Human CYP2C19 Gene Detection Kit (PCR-Fluorescent Probe Method) National Machinery Note: 20243400102 Approval Date: 2024-01-17
Beijing Bell Bioengineering Co., Ltd. *** Product Name: Respiratory Syncytial Virus Nucleic Acid Detection Kit (PCR-Fluorescent Probe Method) National Machinery Note: 20243400103 Approval Date: 2024-01-17
Xiamen Bioexun Biotechnology*** Product Name: Human FMR1 Gene Detection Kit (Fluorescent PCR-Capillary Electrophoresis) National Machinery Note: 20243400096 Approval Date: 2024-01-17
Wuhan Zhongzhi Biotechnology Co., Ltd. *** Product Name: Chlamydia trachomatis nucleic acid detection kit (RNA constant temperature amplification - gold probe chromatography) National Machinery Note: 20243400093 Approval date: 2024-01-10
Shenzhen Mindray Biomedical Electronics Co., Ltd.***Product Name: Cytomegalovirus IgG Antibody Detection Kit (Chemiluminescence Immunoassay Method) National Machinery Note: 20243400094 Approval Date: 2024-01-10
Zhongyuan Huiji Biotechnology Co., Ltd.*** Product Name: Hepatitis B Virus Surface Antibody Detection Kit (Magnetic Particle Chemiluminescence Method) National Machinery Approval: 20243400092 Approval Date: 2024-01-10
Zhongyuan Huiji Biotechnology Co., Ltd.*** Product Name: Hepatitis B Virus E Antibody Detection Kit (Magnetic Particle Chemiluminescence Method) National Machinery Approval: 20243400095 Approval Date: 2024-01-10
Siemens Medical Diagnostics Products (Shanghai)**Product Name: Multiple Protein Controls (Level 2) National Machinery Injection: 20242400035 Approval Date: 2024-01-17
Abbott**(Shanghai)**Product Name: Myoglobin Assay Kit (Chemiluminescence Microparticle Immunoassay) National Machinery Injection: 20242400029 Approval Date: 2024-01-10
Siemens Medical Diagnostics Products (Shanghai)**Product Name: Anti-Streptococcal Hemolysin O Assay Kit (Latex Immunoturbidimetry) National Machinery Injection: 20242400028 Approval Date: 2024-01-10
*: National Medical Products Administration, Da'an Gene, Idea Di.