PeopleBio Develops a Blood Diagnostic for Alzheimer’s disease
입력 2018-10-02 10:24 수정 2018-10-06 07:14
by Euna Lee
PeopleBio, located in Pangyo, Gyeonggi-do is a biotech company which has developed a blood diagnostic kit on neurodegenerative diseases including Alzheimer’s disease. Its kit, capable of detecting the level of oligomerized amyloid beta, involved in AD pathology, in plasma was approved as the class II medical device by the Ministry of Food and Drug Safety in April this year. It is an IVD for the enrichment of the diagnosis of AD. Since its foundation in February 2002, PeopleBio has finally realized a tangible accomplishment after the long-lasting endeavors in research and development.
“PeopleBio will carve the new way into the field of diagnosis of neurodegenerative diseases with the blood-based biomarker detection technology,” at the meeting with the reporter from the Biospectator, Sungmin Kang, the CEO of PeopleBio expressed his vision of the company, “We will become the company which presents the ultimate alternative to the early diagnosis, therapeutic monitoring, advancement to the clinical trial protocols for the development of new drugs and diagnosis research of brain diseases.”
◇ AD Diagnosis and the Development of New Pharmaceuticals Expecting the Advent of “Blood-based Biomarker”
In April 2018, a new diagnostic criterion defining Alzheimer’s disease was proposed. Instead of classifying the disease using marked symptoms such as cognitive decline, using biomarkers was proposed. National Institute on Aging-Alzheimer’s Association (NIA-AA) has classified Alzheimer’s disease into 8 groups using biomarkers of beta amyloid plaques or associated pathophysiologic process (labeled “A”), biomarkers of aggregated pathologic tau or associated pathophysiologic processes (labeled “T”) and Biomarkers of neurodegeneration or neuronal injury (labeled “N”). NIA-AA has added that there is a possibility that new biomarkers can be supplemented to the ATN classification system.
Precedingly in February, FDA prepared a draft of the clinical guideline on the development of new pharmaceuticals for early AD patients. It describes the approval of the use of specific biomarkers as surrogate outcomes to evaluate clinical efficacy on early AD patients with no symptoms. With the importance of biomarkers being emerged, processes on diagnosis and drug development based on biomarkers are accelerated. Furthermore, advent of new biomarkers capable of reflecting clinical manifestation and measuring pre-symptom states is devoutly anticipated...