Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

Primary DI

06974968583223

Basic UDI-DI Code

B-06974968583223

Reference

L000050

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

GeneMind Biosciences Co., Ltd.

Chromosome aneuploidy refers to the increase or decrease in the number of one or more chromosomes in a cell relative to the normal 46 chromosomes in humans. Microdeletion and microduplication syndromes (MMSs) are a class of disorders caused by genomic rearrangements, caused by copy number variations (CNVs) in specific chromosomal regions, including deletions and duplications of DNA segments. At present, the clinical pre-natal screening methods include the combined ultrasound and serologic screening in the first trimester. However, there is a false positive rate of about 3.2%-5.6% with the corresponding detection rate ranging from 60% to 80%. The gold standard for prenatal diagnosis of fetal chromosome abnormality is pre-intervention prenatal diagnostic surgery, in which the corresponding cells are taken through invasive chorionic villus sampling, amniocentesis and percutaneous umbilical vascular puncture for karyotype analysis of fetal chromosomes using cell biology methods. The test result of this technique is accurate, but the test period is long, and the common invasive sampling will pose such risks as water breaking, amnionitis, respiratory distress and even miscarriage. This product is intended for prenatal screening of fetal chromosomal aneuploidies and common microdeletions/duplications based on maternal plasma combined with high-throughput DNA sequencing platform.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).