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1 RegMed 2018 Vol. 88 13 (LDTs) 1 (Laboratory Developed Tests, LDTs) LDTs LDTs LDTs LDTs LDTs LDTs LDT FDA( Food and Drug Administration) LDTs LDTs (In vitro diagnostic device, IVD) (Medical Device) (specification) 1 RegMed 2018 Vol.

2 88 14 IVD IVD LDTs LDTs [1] RegMed 2018 Vol. 88 15 (precision medicine) (Global Market Insight) 2015 1969 2016 2024 [2] Research and Market 2016 2025 1126 [3] LDTs 2016 21 (21st Century Cures Act) (precision medicine initiatives PMI)[5] (personalized medicine) 1990s (human genome project) (next generation sequencing, NGS)

3 75% Life Technologies OncomineTM Dx Target Test 23 DNA [4] RegMed 2018 Vol. 88 16 (single nucleotide variants, SNVs) (deletion) ROS1 (NSCLC) [6] BRAF V600E dabrafenib trametinib ROS1 fusions crizotinib EGFR L858R/Exon 19 deletion gefitnib PraxisTM Extended RAS Panel Illumina RAS [KRAS (exons 2, 3 and 4) NRAS(exons 2, 3 and 4)] 56 panitumumab [7] BRCA1 - [8] (Taiwan Biobank)

4 10 30 12 / LDTs [9] (Array CGH) (spinal muscular atrophy SMA) (non-invasive prenatal testing NIPT) (preimplantation genetic diagnosis PGD) (tuberous sclerosis complex) TSC1 TSC2 (pseudohypoparathyroidism) GNAS1 (medullary thyroid cancer) RET National Comprehensive Cancer Network (NCCN) guideline 66 LDTs RegMed 2018 Vol.

5 88 17 FDA LDTs FDA 2015 20 LDTs [10] 14,000 LDTs OvaCheck OvaSure Screening Test PreOvar KRAS-Variant Test KRAS [11-13] LDTs FDA LDTs LDTs 2014 10 [14] [15] (IVD) FDA LDT [16] LDTs RegMed 2018 Vol.

6 88 18 (Grandfathering) LDTs FDA (Centers for Medicare & Medicaid Services, CMS) (Clinical Laboratory Improvement Amendments, CLIA) 1 LDTs LDTs LDTs LDTs ( [17]) LDTs ( ) CLIA LDTs LDTs LDTs LDTs LDTs LDTs LDTs LDTs 1 CLIA (Clinical Laboratory Improvement Amendments) ( ) CLIA IVD (510(k) or PMA) FDA CLIA [18] 2017 11 510(k) CLIA [19] RegMed 2018 Vol.

7 88 19 PMA IVD / LDTs ( FDA ) IVD / LDTs LDTs LDTs LDTs National Glycohemoglobin Standardization Program (NGSP) Cholesterol Reference Method Laboratory Network (CRMLN) FDA LDTs FDA LDTs FDA LDTs LDTs FDA (New York State Department of Health s, NYSDOH) (Clinical Laboratory Evaluation Program, CLEP) NYSDOH FDA LDTs LDTs (Quality System Requirement) CLIA FDA LDTs CLIA FDA CLIA CLIA FDA (design control) (acceptance activities) (procedures for implementation corrective and preventive action, CAPA) LDTs LDTs (CAPA) LDTs FDA FDA LDTs 2017 1 [16] FDA 2014 FDA FDA LDTs RegMed 2018 Vol.

8 88 20 LDTs CLIA CLIA LDTs LDTs (TFDA) (enforcement discretion) TFDA LDTs LDT LDT LDT LDTs CLIA (CLIA Categorizations) (complexity) CLIA : 1) 2) 3) 4) 5) / 6) 7) ( ) 12 ( ) (moderate complexity) 12 (high complexity) (waiver tests) 2 CLIA 2 (waiver tests) (c) FDA OTC (waiver tests) CLIA RegMed 2018 Vol.

9 88 21 CLIA LDT LDTs LDTs LDTs LDTs LDTs RegMed 2018 Vol. 88 22 LDT LDT CLIA ISO 15189 LDT CLIA/ISO15189 CLIA (CLIA Quality System) (Code of Federal Regulations) 42 CFR (nonwaived) [20] ( ) (specialties) (subspecialties) ~ ISO 15189 [21] / / / / / (management requirements) (technical requirements)

10 ISO 15189 LDTs 3 [22] (LDTs) LDTs 3 13 3 RegMed 2018 Vol. 88 23 LDTs LDTs LDTs (harmonization) 1. ( ) / 2.