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KMID : 1142220150100020189
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Regulatory Research on Food, Drug & Cosmetic
2015 Volume.10 No. 2 p.189 ~ p.195
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Study on Development of IVDMIA Medical Device Evaluation Technology for Personalized Medicine
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Choi Joon-Seok
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Abstract
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Recently, omics-based test methods and bioinformatics technology has been rapidly developed, thus, the biomarkers that have been derived from analyzing the genomic and proteomic information of patients, are applied to personalized medicine. Diagnosis using biomarkers, it can be the key to open the era of personalized medicine as well as a strategic issue of medical research and biopharmaceutical industry. In addition, diagnostic tests using biomarkers could determine whether the onset of the disease, progression of disease progress, and prediction of the patient’s response to treatment, and also, are resolving medical unmet needs in the past. In vitro diagnostics multivariate index assay (IVDMIA) consists of reagents to measure multiple variables and specific algorithm to combine the values of multiple variables using an interpretation function to yield a single, patient-specific result, such as classification, score, and index. IVDMIA is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease. Moreover, algorithm for IVDMIA is possible to develop including clinical data, and more than one algorithm can be applied to a test for the diagnosis of other conditions or disease. In the case of IVDMIA that is developed as a Lab-developed test (LDT), it has to be concerned about the clinical efficacy (Clinical validity) due to insufficient verification of correlation between the complex and unique algorithms, and clinical results, although it has already been used several types of IVDMIA tests, and various IVDMIA have been developed in other countries. In this study, we tried to reviewthe developmental trends, regulations, and guidelines of IVDMIA in other countries in order to ensure the safety and efficacy of IVDMIA, and construct a reasonable evaluation system for IVDMIA. We expect this study would contribute to provision of technical information for the development of IVDMIA, and improvement of the understanding on related products.
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KEYWORD
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In vitro diagnostics multivariate index assay (IVDMIA), approval, evaluation, guideline
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