Good news | High-throughput gene sequencer obtained Class III medical device registration certificate

On September 5, 2023, Basecare DA500 high-throughput gene sequencer officially obtained the third class medical device registration certificate approved by the National Medical Products Administration (NMPA) (National Instrument Registration 20233221281). The gene sequencer is an advanced domestic high-throughput gene sequencer, which adopts rolling loop replication and amplification technology and is equipped with regular array slide, greatly improving the sequencing accuracy, and Q30 data quality reaches more than 85%. DA500 supports two different specifications of chips, can produce 10Gb-150Gb of data throughput, can be clinically used in pre-pregnancy, prenatal, pre-implantation and neonatal gene-related disease screening and other stages of the whole fertility cycle.

Based on the DA500 high-throughput gene sequencing innovation platform, Basecare has developed the first domestic pre-implantation Integrated testing (PGT-Plus) kit. Based on the RET-Seq technology with independent intellectual property rights, the kit can detect PGT-A, PGT-M and PGT-SR clinical items simultaneously by specifically capturing and analyzing SNP genetic markers covering the whole genome. It can also detect clinical diseases such as triploid, haploid, ROH and CNV, which are difficult to distinguish by the current high-throughput sequencing PGT technology, filling the gap in clinical detection of related diseases.

In September 2022, a related study of PGT-Plus was published in Human Reproduction, a well-known journal in the field of reproductive medicine. In the study, 188 embryo samples from 43 families were examined, including 115 PGT-A+SR embryos, 26 PGT-A+M embryos, 26 PGT-A+SR+M embryos, 12 haploid embryos and 9 suspected triploid embryos. The consistency with routine clinical test results reached 100%, indicating that the detection product PGT-Plus based on the innovative high-throughput sequencing platform DA500 has significant clinical significance and innovation.

Basecare adheres to the road of independent research and development, registration and certification, and its self-developed PGT-A kit has obtained the first "National innovative medical device special approval" of the three categories of medical device registration certificate, participated in the drafting of the quality control technology evaluation guide of PGT-A testing reagents, and participated in the formulation of the national PGT-A test kit industry standard. The certification of the DA500 high-throughput gene sequencer is an important milestone in the process of localization of Bekon medical hardware equipment. As a local enterprise in Suzhou, with the support of the industrial innovation cluster in Suzhou Industrial Park, Bekon Medical will help Suzhou Industrial Park to move forward into a "world-class" high-tech park.