초록

1. 혈액-기반 골다공증 바이오마커 개발의 타당성 제시
2. 혈액-기반 골다공증 바이오마커의 국내외 개발현황 분석
3. S1P/DPP4 바이오마커를 이용한 골다공증 진단 키트 개발의 기술적 검토
4. S1P/DPP4 진단 키트의 타질환 분야로의 확대 적용 검토
5. 연구 추진방안 수립

Abstract ▼

I. Objective and necessity of research
1. Objective
1) Establishment of R&D evidence and direction for development of a blood diagnostic kit for osteoporosis, using S1P/DPP4
2) Proposal of R&D strategy for a S1P/DPP4-based diagnostic kit
2. Necessity
1) The medical economic burden of

I. Objective and necessity of research
1. Objective
1) Establishment of R&D evidence and direction for development of a blood diagnostic kit for osteoporosis, using S1P/DPP4
2) Proposal of R&D strategy for a S1P/DPP4-based diagnostic kit
2. Necessity
1) The medical economic burden of osteoporosis becomes an important problem according to aging in a society.
2) Because a S1P/DPP4-based blood diagnostic kit may critically improve diagnostic accuracy and replace the current diagnostic one, the kit may notably reduce osteoporotic economic burden.

II. Results of research
1. By simulation, the detection of S1P/DPP4 reduced osteoporosis care cost.
2. Potential market size : annual 7 trilion KRW per biomarker 1 piece.
3. Our research level of this field is not critically lower than ones of the advanced countries based on their patent status.
4. S1P/DPP4-based diagnostic method has a commercialization potential, because we have their exclusive intellectual property.
5. Global competitiveness measures and distinguished approval strategy in different countries are needed for overseas expansion.
6. Comparison study with C-telopeptide is necessary to prove the role as a killer product.
7. To use as marketing materials, a clinical trial for approval is preferable to be performed in a longitudinal observational cohort study.
8. To expand a clinical utility in bone field, the following additional clinical studies are needed.
- Diagnostic utility to select an individual to be needed for early prevention of osteoporosis
- Diagnostic utility to monitor an effectiveness of anti-osteoporotic drugs
9. Establishment of possibility and method of an ELISA kit manufacture to detect S1P/DPP4 levels, and of strategies of it's preclinical evaluation and clinical verification.
10. The investigation for the detection of S1P/DPP4 isotypes is needed to further improve the diagnostic capacity of the kit.
11. The kit may be utilized in the diagosis of non-infectious chronic inflammatory diseases, such as atherosclerosis and diabetes, but we will focus on its development as an osteoporosis diagnostic kit to effectively accomplish the project.

III. Plan for practical use of research results
1. Development of new osteoporosis clinical guidelines using the blood-based biomarker and reduction of health care cost.
2. International competitiveness improvement of osteoporotic diagnostic kit market by the development of kit.
3. Leading global marker by commercializing high-sensitive diagnostic kits replacing conventional diagnostic kits.