LabGenomics Obtains MFDS Approval for Alzheimer’s Diagnostic Kit... Announces Entry into Alzheimer’s Diagnostic Market
LabGenomics announced on the 22nd that it has obtained domestic approval from the Ministry of Food and Drug Safety for a PCR (polymerase chain reaction) kit that can early diagnose the genetic risk of developing Alzheimer's disease.
Following the release of two PCR kits for diagnosing ankylosing spondylitis and Beh?et's disease in September, the company is gradually expanding its PCR diagnostic range by launching a new PCR kit just two months later.
The newly approved 'LabGun™ ApoE Genotyping Kit' can simply, quickly, and accurately identify the genotypes of amino acids 112 and 158 of the ApoE (apolipoprotein E) gene using real-time PCR. This product received approval from the Ministry of Food and Drug Safety through correlation tests with existing approved products and performance verification using international standard materials.
Among the genotypes determined by single nucleotide polymorphisms (SNPs) of the ApoE gene, the E4 genotype is known as a major genetic risk factor for late-onset Alzheimer's disease. Alzheimer's diagnostic products targeting ApoE gene SNPs are widely used both domestically and globally.
Most diagnostic products are traditional PCR kits that check results after gene amplification is complete, but the newly launched real-time PCR kit by LabGenomics is gaining more attention. The Alzheimer's diagnostic kit will first be sold to domestic diagnostic testing centers, with plans for export to overseas markets such as the United States and Europe in the future.
According to Market Research Future (MRF), a global market research firm, the Alzheimer's diagnostic market is expected to grow from approximately KRW 5.4 trillion in 2023 to about KRW 10.56 trillion by 2032, with an average annual growth rate of 9%.
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Oh Mi-jin, head of research at LabGenomics, stated, "With this newly approved product, it is possible to confirm the presence of the E4 allele, allowing genetic risk assessment for senile dementia. The tests conducted using our Alzheimer's diagnostic kit are very important for early diagnosis, as they enable not only patients suffering from related diseases but also healthy individuals to take preventive measures in advance."
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