Shanghai Genesmart Bioscience Launches YunKeAn™, the First Non-Invasive Prenatal Test for Thousands of Monogenic Disorders (NIPT-M)

Since its inception, Shanghai Weihan’s Biotechnology has accumulated extensive data from large-scale sample experiments, continuously optimized experimental methodologies, and steadily built up expertise. The company now launches the world’s first NIPT-M testing panel targeting thousands of monogenic disorders, enabling non-invasive detection of fetal monogenic mutations through maternal peripheral blood. This innovation marks a breakthrough in the clinical application of non-invasive prenatal DNA testing and contributes to the prevention and control of birth defects in China.

Yunke’an is not limited to detecting dominant genetic disorders caused by specific dozens of gene mutations; it covers over 2,500 monogenic disorders with clearly defined pathogenic mechanisms associated with more than 2,000 genes. It enables accurate and highly efficient testing within a very short turnaround time for any family with a proband (where one or both parents of the proband are carriers of the same pathogenic gene variant). Furthermore, Weihan Biotechnology can perform testing as early as the first trimester (8 weeks of gestation), allowing sufficient time for prenatal diagnosis. Reports indicate that its testing accuracy exceeds 99%, significantly higher than that of conventional prenatal screening. Currently, Weihan Biotechnology has established collaborations with many renowned Grade III Class A hospitals and medical institutions in China. For non-invasive prenatal testing (NIPT) of monogenic disorders, it has completed laboratory testing and analysis on samples from hundreds of families, achieving a 100% concordance rate with amniocentesis validation results.

Prenatal diagnosis refers to the detection and diagnostic assessment of embryonic or fetal developmental status and the presence of diseases before birth. This approach enables early intervention, allowing for timely intrauterine treatment of treatable conditions and informed decision-making in cases of untreatable disorders. Monogenic genetic diseases are highly diverse, with an overall incidence rate of 1/100. They often cause congenital malformations, disabilities, or even death, and are difficult to treat, posing a significant threat to human health. Therefore, strengthening prenatal diagnosis is crucial for the prevention and control of birth defects.

Currently, the primary technologies used for prenatal genetic disease testing include nuchal translucency (NT) ultrasound, maternal serum screening during pregnancy, chorionic villus sampling (CVS), amniocentesis, cordocentesis, and non-invasive prenatal testing (NIPT). NIPT products available on the market are mainly applied to the detection of fetal chromosomal abnormalities. NT ultrasound must be performed between 11 and 13 weeks of gestation, with a positive detection rate of only 60%–80%. Maternal serum screening is conducted between 15 and 20 weeks of gestation, with a positive detection rate below 90%. Furthermore, CVS, amniocentesis, and cordocentesis are invasive procedures that carry risks of teratogenicity and miscarriage. To integrate the advantages of existing prenatal genetic testing products and achieve early, safe, and accurate prenatal detection of monogenic genetic disorders, Vansure Biotechnology has launched the Yunke’an project (Non-Invasive Prenatal Testing for Monogenic Diseases, NIPT-M).

Noninvasive Prenatal Testing (NIPT): This refers to the prenatal detection of cell-free fetal DNA in maternal peripheral blood, primarily used for screening fetal chromosomal aneuploidies. In contrast, Noninvasive Prenatal Testing for Monogenic Disorders (NIPT-M) differs from conventional NIPT. It involves collecting maternal peripheral blood and applying next-generation DNA sequencing technology to sequence cell-free DNA (cfDNA) fragments. The sequencing data then undergoes computational processing and bioinformatic analysis to determine whether the fetus has inherited monogenic mutations from its parents, playing a crucial role in reducing the incidence of birth defects. Noninvasive prenatal testing for monogenic disorders is gradually becoming the mainstream direction for the clinical application of NIPT worldwide.

As the first NIPT-M testing program both domestically and internationally targeting thousands of monogenic disorders, Yunke’an offers extensive coverage, encompassing over 1,300 autosomal dominant and over 1,300 autosomal recessive monogenic diseases. Testing can be performed as early as 8 weeks of gestation using maternal peripheral blood, enabling effective assessment of whether the fetus carries pathogenic mutations and facilitating timely clinical diagnosis. Furthermore, a negative test result eliminates the need for invasive procedures such as amniocentesis, thereby effectively avoiding risks of infection, teratogenicity, or miscarriage. On a deeper level, Yunke’an helps interrupt the vertical transmission of monogenic genetic diseases, aligns with national policies on eugenics and healthy childbirth, and contributes to the prevention and control of birth defects in China.

Yunkean provides valuable guidance for couples or families in which one or both partners have been confirmed through genetic testing (diagnostic or screening) to have a specific monogenic disorder or to be carriers of pathogenic variants, as well as for families who have previously given birth to children with monogenic disorders and for pregnant women who have undergone preimplantation genetic testing for monogenic defects (PGT-M). Gao Pengfei, CEO of WeihanS Biotech, once stated, “While genetic testing examines the past, what you seek is the future. WeihanS aims to provide more direct and effective recommendations related to reproductive planning for the next generation.” The launch of the Yunkean project aptly reflects WeihanS Biotech’s consistent commitment to “professionalism” and “focus” in product development and clinical application.

Since its establishment, Weihan Biotechnology has been dedicated to research in the field of genetic disease screening and testing. To date, it operates an independent third-party medical laboratory (LDT/Shanghai), as well as IVD (genetic testing kits and equipment) and POCT production bases (equipment and supporting reagents). Its business portfolio encompasses genetic disease screening (tertiary prevention), auxiliary diagnosis of genetic disorders, testing for infertility and products of conception, assisted reproductive technology-related testing (PGT), kinship analysis, and scientific research collaborations focused on genetic diseases. Recognized as a top-tier enterprise in China’s genetic testing industry, Weihan Biotechnology has established robust partnerships with hundreds of leading medical institutions and experts. In the future, Weihan Biotechnology will launch a series of prenatal genetic testing products; stay tuned.