Suzhou Basecare Medical Corporation Limited (Basecare) announced that on 28 April 2026 it received a national Class III medical device registration certificate (No. Guo Xie Zhu Zhun 20263400858) for its internally developed “Pre-implantation Genetic Testing Kit for Thalassemia (Semiconductor Sequencing Method)” (PGT-M Kit). This is the first domestically produced pre-implantation genetic test for thalassemia approved for commercial use in China.

The PGT-M Kit performs qualitative detection of genomic DNA from trophectoderm cells of in-vitro cultured embryos, as well as from parents and relevant relatives, enabling clinicians to determine whether an embryo has inherited pathogenic variants associated with thalassemia and select suitable embryos for transfer.

Thalassemia, an autosomal recessive haemoglobinopathy, affects an estimated 30 million carriers in China, with about 300,000 individuals suffering from severe or intermediate forms and an annual growth rate of roughly 10%. Each pregnancy between two carriers carries a 25% risk of producing an affected child. Basecare’s kit—developed under the mainland’s 14th Five-Year Plan R&D initiative on “Reproductive Health and Women and Children’s Health Protection”—aims to curb transmission of thalassemia genes and lower birth-defect incidence.

Basecare holds more than 50% of China’s PGT-compliant market, collaborates with approximately 300 hospitals nationwide, operates over 60 joint laboratories and partners with more than 80 third-generation reproductive centers. The new PGT-M Kit expands the company’s portfolio, which already includes PGT-A and PGT-SR assays, and is positioned to bolster revenue from its genetic laboratory business while reinforcing its domestic market leadership.

The National Health Commission continues to prioritise birth-defect prevention and standardized genetic testing pathways for conditions such as thalassemia. Basecare’s newly approved PGT-M Kit provides a targeted tool aligned with these public-health goals.

The company cautions shareholders and prospective investors to exercise prudence when dealing in its shares.