實驗室自行研發檢驗方法的監管架構【本期企劃】 試閱
Framework for Regulatory Oversight of Laboratory Developed Tests
世界各國近年來在精準醫療領域傾注大量資源，而新興技術的進步無論在疾病篩檢、癌症的治療策略等領域均被寄予深厚期望，期待能依個體化差異為精準診斷及治療，減少副作用與醫療支出上的浪費。然而，此類檢驗技術門檻高，檢驗操作、報告判讀須仰賴專業人員純熟的技術經驗和品質優良的醫學實驗室。本文將介紹美國、歐盟之規範，並探討臺灣目前所面臨之法律議題，以病人安全為首要考量，研擬完善之監管政策，促進國人的健康，並豐厚精準醫療的利基。
Laboratory developed test (LDT) is a term used to refer to a certain type of in vitro diagnostics and medical professionals have used LDTs to diagnose diseases. LDTs nowadays have evolved and proliferated significantly in precision medicine, shedding further light on disease management and leading to actionable interventions. However, besides a highly-sophisticated laboratory, LDTs require well-trained professionals with considerable expertise, knowledge, and experience. With advances in technology and business models, the LDT oversights are being discussed. LDTs have direct effect on the care that patients receive; therefore, patient safety must always be the top priority. The article not only aims to review the regulatory oversights and governance in the U.S. and the European Union but also addresses the current legal concerns in Taiwan.
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