Good news | Basecare Medical PGT-A analysis software obtained medical device registration certificate
On June 23, thepreimplantation chromosomal aneuploidy analysis software of Basecare Medicalsuccessfully obtained the class II medical device registration certificate(Registration Certificate No.: sxzz 20222211356). The approval of the PGT-Aanalysis software has been certified, which truly ensures the quality level of PGT-Atesting in sample management and data analysis, minimizes the interference ofhuman factors in data interpretation, and is more conducive to the clinicaldevelopment of PGT-A and the corresponding genetic counseling.
The functionalmodules of this analysis software include the sample management module and thedata analysis module, which can be used together with the relevant genesequencer to analyze the deoxyribonucleic acid (DNA) sequence data ofchromosome aneuploidy generated by the sequencing of the gene sequencer beforeembryo implantation, so as to assist in judging the chromosome aneuploidy ofthe embryo before tube baby implantation (excluding the detection of chromosomesegment deletion / duplication and chimerism).
Thecertification of PGT-A analysis software this time is another embodiment of theconcept of "innovative products" that Basecare Medical has alwaysadhered to. Basecare Medical has been strictly ensuring quality control withtechnical innovation and compliance certification, and strives to achievehigh-quality output in every link from sampling to detection to analysis. As aresult, Basecare Medical has been fully certified in the kit, instrument andequipment and analysis software around PGT-A, forming a closed loop, fillingthe gap in the clinical kit and analysis software, and promoting the clinicalapplication of PGT technology.
In addition, theregistration and certification of PGT-M and PGT-SR product pipelines of BasecareMedical are also actively promoted. The clinical trial recruitment of PGT-M preimplantationthalassemia detection kit has been carried out in four reproductive centersacross the country, which will truly block the inheritance of thalassemia genesto the next generation, and help the thalassemia families to have healthychildren. In the future, Basecare Medical will continue to be committed to theindependent research and development and registration of product pipelines inthe field of assisted reproduction, create a complete three generation tubebaby product pipeline, and lead the localization and replacement of a fullrange of products in the field of assisted reproduction with innovativetechnologies.