Korea's first multi-analysis test for genes by disease… Contribution to early detection of hearing loss of all ages, such as congenital, elderly, and juveniles

The'U-TOP HL Genotyping kit', a genetic test product for congenital hearing loss from SeaSun Biomaterials (CEO Park Hee-kyung), was listed on the health insurance benefit category on the 2nd.

According to the company on the 6th, the registration decision was made only two and a half years after receiving a manufacturing license from the Ministry of Food and Drug Safety in January 2016. The registration was delayed due to the lack of a well-established payment system for multi-analysis tests for genetic diseases. It is expected to become a vitality for the entire industry.

Existing genetic testing is a process in which mutations are identified through full nucleotide sequence analysis of each biomarker gene, so it has a defect that incurs a test period of several weeks and an expensive test cost of millions of won. On the other hand, the SeaSun Biomaterials diagnostic product reduced the cost of testing to a tenth of the previous level by simultaneously analyzing mutations in five genes that cause disease in just two hours. By significantly reducing the analysis time and examination cost, the burden on the patient can be reduced and it can contribute to the activation of treatment.

Congenital hearing loss is a disease with the highest incidence among congenital diseases, and it appears in about 3 per 1,000 newborns, and it has been studied that if not treated early, it can cause not only speech impairment but also overall development. Half of congenital hearing loss is caused by genetic factors, and even if the parent does not have hearing loss, if the carrier has the hearing loss gene, the child may have hearing loss, so it is necessary to confirm the possibility of hearing loss through genetic testing.