Medipron Receives MFDS Approval for Dementia Diagnostic Kit... "Expecting Global Market Entry"

[Asia Economy Reporter Yoo Hyun-seok] Mediphron Divity, a new drug development bio company, announced on the 21st that its 'in vitro diagnostic medical device that helps confirm the accumulation of beta-amyloid in the brain' (hereinafter referred to as the ‘dementia diagnostic kit’), developed jointly with Quantamatrix, a specialized in vitro diagnostic device company, has obtained product approval from the Ministry of Food and Drug Safety (MFDS).

The dementia diagnostic kit, which received product approval from the MFDS, is a diagnostic device that confirms the accumulation of beta-amyloid in the brain, an indicator for diagnosing Alzheimer's disease, by measuring multiple biomarkers in the blood. It was completed through the combination of Mediphron's proprietary technology on biomarkers and Quantamatrix's world-class multiplex marker diagnostic platform technology.

CEO Noh Ki-seon of Mediphron said, "Since 2004, Mediphron has made various efforts to develop diagnostic devices that can detect Alzheimer's disease dementia early." He added, "This dementia diagnostic kit measures multiple biomarkers to overcome the limitations of single blood biomarkers and applies a unique algorithm to determine the accumulation of beta-amyloid in the brain, assisting in the diagnosis of Alzheimer's disease as an in vitro diagnostic medical device." He continued, "In particular, unlike existing products that target patients with severe dementia, our diagnostic kit can be applied not only to patients with cognitive impairment but also to asymptomatic high-risk groups (elderly), differentiating it from existing diagnostic technologies."

Until now, the diagnosis of Alzheimer's disease, which accounts for 60-70% of all dementia patients, has been determined by the accumulation of beta-amyloid in the brain, using expensive imaging equipment called ‘Amyloid PET’ or cerebrospinal fluid tests via lumbar puncture as alternatives. Both methods have concerns such as high cost, limited accessibility, and side effects. However, the dementia diagnostic kit, which recently received product approval from the MFDS, can diagnose dementia early through a simple blood test. The company explained that this could dramatically reduce the financial burden on the public.

Mediphron and Quantamatrix plan to promptly complete the ongoing new medical technology assessment procedure to expedite the market launch of the dementia diagnostic kit. The new medical technology assessment is a system where the Korea Health Industry Development Institute under the Ministry of Health and Welfare evaluates newly developed innovative medical devices like the dementia diagnostic kit, separate from the MFDS product approval. Passing this evaluation will allow the dementia diagnostic kit to be the first of its kind to be marketed domestically. Furthermore, the dementia diagnostic kit has also received export approval from the MFDS, raising expectations for entry into the global dementia market as well as the domestic market.

Mediphron expects that once the diagnostic kit is launched, it will serve as the company's cash cow due to its lower cost and convenience compared to existing diagnostic methods. Through this, the company plans to establish a virtuous cycle by reinvesting in expanding new pipelines, such as the clinical phase 1 trial of non-narcotic analgesics and dementia therapeutics, as well as collaborating with NewMace, the world's first company developing atherosclerosis diagnostic and therapeutic agents, thereby growing into a bio company with strong fundamentals.

This content was produced with the assistance of AI translation services.