SEASUN BIOMATERIALS announced on the 23rd that the 'SSu-ApoE' diagnostic kit, which quickly and easily identifies the genotype of Apolipoprotein E, known as the gene for causing Alzheimer's, has been certified as an in vitro diagnostic medical device by the Ministry of Food and Drug Safety on the 22nd. .

The ‘SSu-ApoE’ product analyzes the ApoE genotype of blood or oral epithelial cells with an automated program to provide quantified and objective analysis results. Unlike other products that use two or more tubes, which is complicated and time-consuming, and can only check whether E2·E4 allele is detected or not, it can be tested in one tube and can be tested for 4 types of ApoE genotypes (E1, E2, E3, E4) can be analyzed simultaneously.

Alzheimer's disease is caused by the accumulation of beta-amyloid in the brain. Among them, it is reported that the incidence of Alzheimer's disease or arteriosclerosis (heart disease) increases when the ApoE gene, which is received from each parent, has the same allele. For example, among the three alleles with a high probability of inducing Alzheimer's disease, E2/E2, E3/E3, and E4/E4, patients with the E4/E4 allele genotype have an Alzheimer's disease incidence rate of 2 to 3 times that of the general population, at a level of 60%. reach In addition, it is reported that more than 94% of dementias caused by this genotype are pathologically Alzheimer's disease.

Alzheimer's disease, which accounts for more than 70% of dementia, has a long asymptomatic period of 15 to 20 years and is diagnosed through a variety of comprehensive tests such as a questionnaire or brain imaging. However, brain imaging tests such as magnetic resonance imaging (MERI) are expensive and burdensome for patients.

Park Hee-kyung, CEO of SEASUN BIOMATERIALS, said, SSu-ApoE is not a diagnostic test for dementia, but it is a useful tool for primary screening.


관련전문:
https://newsis.com/view/?id=NISX20210723_0001523840&cID=10201&pID=10200
https://news.mtn.co.kr/newscenter/news_viewer.mtn?gidx=2021072310135033449
http://www.mdtoday.co.kr/mdtoday/index.html?no=425808
https://www.kpanews.co.kr/article/show.asp?idx=224337&category=D
http://www.whosaeng.com/128864