Commercialization of early diagnosis kit for'CMV infection', a factor of congenital hearing loss

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Commercialization of early diagnosis kit for'CMV infection', a factor of congenital hearing loss

운영자
Date 2021.01.26
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Preoccupying the market for early hearing loss diagnosis with hereditary hearing loss kit

A genetic diagnostic kit that diagnoses early childhood infections with cytomegalovirus (CMV), which causes congenital hearing loss in infants, has been released.

On the 13th, SeaSun Biomaterials (CEO Park Hee-kyung) said that the 'U-TOP CMV Detection Kit', an infectious infant hearing loss test kit, was approved as an in vitro diagnostic medical device (Class 3) from the Ministry of Food and Drug Safety. It was revealed on the 15th.

Cytomegalovirus (CMV) is a pathogen of the herpesvirus family that more than 60% of adults around the world infect at once in a lifetime. Once infected, it remains dormant in the body for life and generally does not cause infectious diseases, but fetal infections cause fatal diseases. Can cause. When a mother is infected with CMV, about 40% of the fetus is vertically infected, and about 1 in 150 newborns each year show congenital CMV infection. This can lead to miscarriage, infant hearing loss, visual impairment, microcephaly, growth delay, and cerebral palsy.

U-TOP CMV Detection Kit performs a real-time PCR test on CMV DNA present in the urine of infants, and the results can be confirmed within 3 hours. It is also a strength of being able to easily produce test results for 94 samples at the same time by using a dedicated analysis program at a front line hospital or clinical analysis company.

With the release of the U-TOP CMV detection kit, SeaSun Biomaterials has further strengthened its congenital hearing loss diagnosis platform. The U-TOP HL Genotyping Kit, a genetic testing product for inherited hearing loss that has been covered by insurance benefits from July of this year after receiving an item license in January 2016, has recently been rapidly distributed in clinical sites, and this time it was approved. This is because it is expected to be possible to diagnose both inherited and infectious hearing loss in infants through an integrated test with.

Representative Park Hee-kyung said, “The induced diacoustic radiation test and the auditory brainstem response test, which are currently used in the neonatal auditory screening test, are tests to confirm the degree of hearing or structural abnormalities in the ear. SeaSun Biomaterials's two hearing loss kits are not only quick and accurate, but can also compensate for the limitations of existing tests because they can precisely pinpoint the factors responsible for hereditary and infectious hearing loss, which account for the majority of congenital hearing loss.” She added, "Congenital CMV infection should be tested within 3 weeks after birth to know the exact result, but some infants may develop hearing loss symptoms several months after birth, so it is necessary to test even if there is no symptom.

In 1994, the Infant Hearing Cooperation Committee (JCIH) under the National Institutes of Health defined 10 factors in high-risk groups for hearing loss that require early hearing testing. Among them, they pointed out that family history (hereditary) accounts for half of the high risk factors and fetal CMV infection accounts for about 21%. In particular, even though CMV is the most common virus infecting fetuses and infants, most parents are not aware of the risk of CMV infection, and recommended that infants with hearing loss must perform CMV testing. An official of SeaSun Biomaterials said, “The U-TOP HL kit and U-TOP CMV Kit can detect the cause of hearing loss using the same analysis equipment, so applying it to the complete hearing loss test for infants can greatly contribute to the development of epidemiological investigations and clinical treatment technology. Will” he emphasized.