The Health Planning Commission stopped all non-invasive prenatal screening and diagnosis pilots (with full text)

Recently, the National Health and Family Planning Commission issued the "Notice on Regulating the Blood Screening and Diagnosis of Fetal Free DNA Production in Pregnant Women's Peripheral Blood" (hereinafter referred to as the Notice). The notice specifically pointed out that the Notice of the Women and Children Division of the National Health and Family Planning Commission on the pilot work of prenatal diagnostic institutions for high-throughput gene sequencing for prenatal screening and diagnosis clinical application and the National Health and Family Planning Commission Medical Administration and Hospital Authority on the development of Qualcomm The relevant provisions of the pilot organization for prenatal screening and diagnosis involved in the “Notice on the Clinical Application of Sequencing Technology” should be abolished and 108 clinical pilot units cancelled. All hospitals with prenatal testing qualifications can carry out non-invasive DNA in principle. Prenatal screening and diagnosis; cancellation of clinical trials of 7 medical laboratories, all medical laboratories with clinical gene amplification laboratory qualifications can in principle conduct non-invasive DNA prenatal screening and diagnosis, and require relevant institutions and personnel And the actual equipment must obtain new licenses, certificates and approvals before it can be approved for work.

At the same time, the Notice has listed three requirements for screening agencies:

(1) Medical institutions that carry out prenatal screening and diagnosis of fetal free DNA in pregnant women's peripheral blood should obtain the Prenatal Diagnostic License for Maternal and Infant Health Care Technical Services.

(2) The medical institution that carries out prenatal screening and diagnosis of blood collection services for pregnant women with peripheral blood of pregnant women shall be qualified prenatal screening or prenatal diagnosis institutions. The prenatal screening institution that conducts the learning service shall establish a cooperative relationship with the prenatal diagnostic institution and file with the provincial health and family planning administrative department.

(3) Medical institutions that carry out laboratory testing of fetal free DNA in pregnant women's peripheral blood should have the qualification of clinical gene amplification testing laboratory, strictly abide by the "Administrative Measures for Clinical Laboratory of Medical Institutions" and "Management of Clinical Gene Amplification Testing Laboratory for Medical Institutions" According to the relevant provisions of the Measures, the corresponding inspection items shall be subject to the inter-room quality evaluation organized by the Clinical Inspection Center of the National Health and Family Planning Commission.

In addition, the Notice also sets clear requirements for the equipment reagents involved in the prenatal screening and diagnosis of fetal free DNA in pregnant women:

(1) Based on the cytogenetic laboratory diagnostic equipment, it also has the main equipment for prenatal screening and diagnosis of fetal free DNA in pregnant women, including DNA extraction equipment, PCR instrument, high-throughput gene sequencer. Or other molecular testing equipment. The type and quantity of equipment should match the actual test items and the amount of inspection.

(2) The data analysis software for equipment and kits shall comply with the relevant regulations of the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Administration of Medical Device Registration Certificates, and shall be registered and approved by the Food and Drug Administration.

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