PeopleBio Receives European CE Certification for Early Diagnosis Kit of Alzheimer's Disease

[Asia Economy Reporter Minji Lee] PeopleBio, a bio company specializing in blood-based neurodegenerative diseases, announced on the 25th that its blood-based early diagnosis kit for Alzheimer's disease has received European CE certification.

The blood-based early diagnosis kit for Alzheimer's disease that received CE certification measures the degree of oligomerization of beta-amyloid in the blood to assess the risk of onset. It was developed based on PeopleBio's proprietary patented technology, MDS, and is the world's first commercially available kit to assist in the diagnosis of Alzheimer's disease.

CE certification is a mandatory mark for sales within Europe, indicating compliance with EU Council directives on safety, health, environment, and consumer protection. For this CE certification, clinical trials were conducted in Europe to verify applicability to Europeans, and based on the results, the CE certification was applied for.

With this certification enabling product sales in Europe, PeopleBio plans to select reliable partners within Europe, sign licensing agreements, and expand into the European market.

A PeopleBio official stated, "This certification will not immediately translate into sales, but it opens opportunities to enter advanced countries such as Europe," adding, "We are striving to fulfill the promises made since the listing stage and respond to the support of our shareholders."

Meanwhile, PeopleBio has been actively establishing testing services at major health screening centers such as Hanshin Medipia since the second half of this year and is preparing testing services for dementia insurance subscribers. By the second half of next year, the goal is to provide services through all channels capable of testing, including public health centers and hospitals, offering a new paradigm in dementia diagnosis and management.