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Abnova — Interim / Quarterly Report 2017
Aug 18, 2017
52384_rns_2017-08-18_2f2d74c3-9e6f-4b34-adf8-6680341a318c.pdf
Interim / Quarterly Report
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1
Safe Harbor Notice
The following pages contain projections & estimates of financial information as well as market and product developments for future periods. These projections & estimates are based on information currently available which we believe to be reliable, but they involve risks & uncertainties. Our actual results of operations & financial condition may differ significantly from those contained in the projections & estimates. The projections & estimates should not be interpreted as legally binding commitments, but rather as flexible information subject to change occasionally.
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Agenda
✓ Company Overview
✓ Q2&H1-2017 Financial Results
✓ Abnova’s Opportunities in Precision Medicine
✓ Q&A
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I. ABNOVA COMPANY PROFILE
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Abnova Company Profile
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Bioreagent Global Distribution Network
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Consolidated Income Statement Q2&H1 2017
| In NT$K | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Q2‘17 | % | Q2‘16 | % | H1‘17 | % | H1‘16 | % | H1 YOY | |||||
| Net Revenue | 122,348 | 100.0% | 111,519 | 100.0% | 242,005 | 100.0% | 229,327 | 100.0% | 5.5% | ||||
| Cost of Revenue | (65,174) | (53.3%) | (60,178) | (54.0%) | (125,725) | (52.0%) | (121,763) | (53.1%) | 3.3% | ||||
| Unrealized Gross Profit on Sales to Associates |
(2,190) | (1.8%) | (3,261) | (1.3%) | |||||||||
| Gross Profit | 54,984 | 44.9% | 51,341 | 46.0% | 113,019 | 46.7% | 107,564 | 46.9% | 5.1% | ||||
| Operating Expense | (42,750) | (34.9%) | (42,399) | (38.0%) | (82,455) | (34.1%) | (80,606) | (35.1%) | 2.3% | ||||
| Operating Income | 12,234 | 10.0% | 8,942 | 8.0% | 30,564 | 12.6% | 26,958 | 11.8% | 13.4% | ||||
| Non Operating Income | 8,098 | 6.6% | 383 | 0.3% | 3,518 | 1.5% | (407) | (0.2%) | (964.4%) | ||||
| Income before Tax | 20,332 | 16.6% | 9,325 | 8.4% | 34,082 | 14.1% | 26,551 | 11.6% | 28.4% | ||||
| Income after Tax | 17,027 | 13.9% | 13,216 | 11.9% | 28,884 | 11.9% | 27,876 | 12.2% | 3.6% | ||||
| Basic EPS after Tax | 0.29 | 0.22 | 0.49 | 0.47 |
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Revenue Breakdown by Product
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In NT$K 2017 Jan-Jul
500000
16,739
400000 16,661
69,542
66,469 4.5%
16.9%
300000
48,354
200000 38,441 13.5%
65.1%
100000
339,844 332,794 186,202
0
2015 2016 2017Jan-Jul
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Antibody & Reagent Protein CTC instrument & kits Others
Antibody & Reagent Protein CTC instrument & kits Others
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II. ABNOVA PRECISION MEDICINE
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Abnova Core Competence in Precision Medicine A Vertically Integrated In Vitro Diagnostic Company
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In Vitro Diagnostics
CytoQuest CR
System Integration CytoQuest Dx
GMP Bioreagents CytoBot
Instrumentations CytoAmp
Softwares CytoPrep
Antibody Bank
One Gene One Antibody
Resource & Support
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Applications of Prenatal & Cancer Precision Medicine
Precision Medicine
Prenatal Prevention and Detection
Cancer Prevention and Detection
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Amniocentesis (Invasive Prenatal Testing)
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NIPT (Non-Invasive Prenatal Testing)
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NIPD (Non invasive prenatal diagnosis)
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Surrogate Diagnosis
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Early Cancer
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Cancer Relapse
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Cancer Metastasis
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Drug Guidance
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Drug Resistance
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Treatment Response
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Tissue vs. Liquid Biopsy in Precision Medicine
Tissue Biopsy
Liquid Biopsy
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Invasive
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Non-invasive
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Painful
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Time saving
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Costly
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Real-time monitoring
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Takes time
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Regular monitoring
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Risky
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Not enough tissue sample available
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Liquid Biopsy is � Not enough tumor tissue in the sample useful when there is: � A hard-to-reach tumor � Need for regular monitoring
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Liquid Biopsy Applications in Precision Medicine
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CTC cfDNA Samples: 1. Blood 2. Urine 3. Other body fluid Exosome Detection Monitoring Surrogate Diagnosis Treatment Response Early Cancer Screening Drug Resistance Cancer Metastasis Cancer Relapse/Recurrence Drug Guidance
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Abnova Precision Medicine Market Footprint in China, Japan & Taiwan
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Abnova Diagnostics (Tokyo)
Wellconn Genomics (Neihu)
Abnova Diagnostics (Dongguan) Wellconn Genomics (Dongguan)
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III. ABNOVA DIAGNOSTICS (PRECISION MEDICINE PRODUCTS)
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CytoQuest™ CR
Circulating Rare Cells Positive Enrichment & Retrieval System
Integrated System
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Buffer reservoir
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Fluidic pump
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SCx™spiral chamber
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Coupler
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HBx™micromixer
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Chip receptor
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TCx™thermal chuck
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Touch user interface
Antibody-based, cell capture
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Cell enumeration (CytoChipNano)
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Single cell isolation (CytoChipNano)
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Thermal cell release (CytoChipNano CR)
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CytoQuest CTC Bioreagents & Consumables
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Unique Features of CytoQuest™ CR (1)
Capture & Recovery Rate of Spiked Cells in Whole Blood
Abnova Proprietary Cell-Surface Vimentin Antibody is Universal for CTC, EMT CTC, & CSC. Cell-Surface Vimentin is Specific for Cancer
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Abnova Proprietary EpCAM Antibody
Capture Rate Depends on Quality of Antibody
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Unique Features of CytoQuest™ CR (2)
Viable CTC Capture in Diverse Cancers
Single Cell Isolation, Whole Genome Amplification (WGA), & Sequencing
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On-Chip Molecular Analysis with FISH Probes
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Viable CTC Release in Epithelial Cancers
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CytoQuest™Dx Circulating Tumor Cell Positive Enrichment & Retrieval Automation
CytoQuest™ Dx Integration
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Total Solution Workstation
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XYZ Axis and 6 Axial Robotic Arm
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In-Process Controls & Sensors
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Intelligent Software Algorithm
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Self-Contained Modules
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RFID Consumable Tracking
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Clean Environment & HEPA Filter
CytoQuest™ Dx Advantages
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Precision, Accuracy, & Reproducibility
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High Throughput & Multi-Tasking
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Minimize Cross Contaminations
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Positive Selection Cell Isolation
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CytoBot™
Circulating Tumor Cell Negative Enrichment & Retrieval Automation
CytoBot™ Integration
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Total Solution Workstation
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Two 6 Axial Robotic Arms
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In Process Controls & Sensors
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Intelligent Software Algorithm
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Self-Contained Instruments
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Clean Environment & HEPA Filter
CytoBot™ Advantages
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Precision, Accuracy, & Reproducibility
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High Throughput & Multi-Tasking
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Minimize Cross Contaminations
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Negative Selection Cell Isolation
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Proprietary Cell-Surface Vimentin (CSV) Antibody Universal CTC, EMT CTC, and CSC Antibody Cell-Surface Vimentin (not EpCAM) is Specific for Cancer
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CSV+ CD133- CSV- CD133+
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Figure 1. Analysis of colon cancer derived CSV+ CD45- CTCs from patient samples stained with EMT marker specific antibodies and anti-CSV monoclonal antibody, clone 84-1.[1]
Satelli A., et al., Clinical Cancer Research 2015; 21(4): 899-906. Mitra A., et al., International Journal of Cancer 2015; 137: 491-496.
Figure 2. A) Matrigel sphere formation assay of CSV+ CD133- and CSV- CD133+ cells isolated from hepatocellular carcinoma (HCC) at Day 7. Both spheres were stained with stem cell associated markers, Sox2 and Oct4A. B) CSV+ CD133- cells from HCC metastasize at a higher rate than CSV- CD133+ and CSV- CD133- cells.[2]
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Proprietary Cell-Surface Vimentin (CSV) Antibody CTC Clinical Applicable for EMT and Mesenchymal Tumors
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Cancers Epithelial Tumors
EMT Tumors Mesenchymal Tumors (Glioma, Sarcoma, Melanoma)
Curr Pathobiol Rep (2014) 2: 21-26.
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Cell-Surface Vimentin (CSV) Publications
| Author | Year | Journal |
|---|---|---|
| Izhar Singh Batth |
2017 | Circulating tumor markers: harmonizing the yin and yang of CTCs and ctDNA for precision medicine. |
| Annals of Oncology | ||
| Arun Satelli | 2016 | Potential role of nuclear PD-L1 expression in cell-surface vimentin positive circulating tumor cells as a prognostic marker in cancer patients. |
| Scientific Reports | ||
| Hyangsoon Noh | 2016 | Discovery of cell surface vimentin targeting mAb for direct disruption of GBM tumor initiating cells. |
| Oncotarget | ||
| Abhisek Mitra | 2015 | EMT, CTCs and CSCs in tumor relapse and drug-resistance. |
| Oncotarget | ||
| Arun Satelli | 2015 | Circulating Tumor Cell Enumeration with a Combination of Epithelial Cell Adhesion Molecule– and Cell-Surface Vimentin–Based Methods for Monitoring Breast Cancer Therapeutic Response. |
| Clinical Chemistry | ||
| Abhisek Mitra | 2014 | Cell-surface Vimentin: A mislocalized protein for isolating csVimentin+CD133- novel stem-like hepatocellular carcinoma cells expressing EMT markers. |
| International Journal of Cancer | ||
| Arun Satelli | 2014 | Epithelial–Mesenchymal Transitioned Circulating Tumor Cells Capture for Detecting Tumor Progression. |
| Clinical Cancer Research | ||
| Arun Satelli | 2014 | Epithelial–Mesenchymal Transitioned Circulating Tumor Cells Capture for Detecting Tumor Progression. |
| Clinical Cancer Research (Supplement) | ||
| Arun Satelli | 2011 | Vimentin as a potential molecular target in cancer therapy Or Vimentin, an overview and its potential as a molecular target for cancer therapy. |
| Cellular and Molecular Life Sciences | ||
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CTC Clinical Applications Disease, Drug, & Surgery – Detection, Selection, & Monitoring
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Disease Detection & Monitoring
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Surrogate Diagnosis
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Early Cancer Detection
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Remission
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Relapse/Recurrence
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Metastasis
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Drug Selection & Monitoring
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Drug Guidance (Companion Diagnostics)
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Drug Response
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Drug Resistance
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Surgical Selection & Monitoring
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Surgical Guidance
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Surgical Response
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Surgical Resistance
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Cancers & CSV CTC Clinical Applications (1)
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Cancers & CSV CTC Clinical Applications (2)
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Viable CTC Capture & Detection in Diverse Cancers (1)
Cell-Surface Vimentin as Novel EpithelialMesenchymal Transition and Cancer Stem Cell Biomarkers for Pancreatic Cancer Circulating Tumor Cells
EpCAM CK Positive Circulating Tumor Cells and B7-H3 CD105 Positive Cancer Stem Cells in Clear Cell Renal Cell Carcinoma
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Capture and Isolation of EpCAM and CD133 Positive Cells in Peripheral Blood of Non-Small Cell Lung Cancer Patients
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PSMA vs EpCAM Antibody Capture of Circulating Tumor Cells in Metastatic Castration-Resistant Prostate Cancer Patient
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Viable CTC Capture & Detection in Diverse Cancers (2)
CDX2 Intestinal-Specific Expression in Circulating Tumor Cells of Metastatic Colorectal Adenocarcinoma Patient
Plastin-3 Transformed Circulating Tumor Cells in Hepatic Protal Vein of Pancreatic Cancer Patient for Predicting Liver Metastasis
Androgen Receptor Gene Amplification in Circulating Tumor Cells of Metastatic Castration-Resistant Prostate Cancer Patient
Cell-Surface Vimentin Transformed EMT CTCs and CSCs in Metastatic Castration-Resistant Prostate Cancer
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Cell-Surface Vimentin and Pan Cytokeratin Positive Circulating Tumor Cells in Pleural Effusion of Lung Adenocarcinoma Patient
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Antibodies Targeting ASGPR and PanCK for Capture and Identification of Circulating Hepatocellular Carcinoma Cells
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Viable CTC Capture & Detection in Diverse Cancers (3)
Circulating Epithelial Cells in Dialysis Patient with Antibodies Targeting HLA-G and PanCK for Acquired Cystic Kidney Disease Capture and Identification of Circulating Choriocarcinoma Cells
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Detection of Circulating Tumor Cells in Cholangiocarcinoma Patients
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Circulating Tumor Cells as Metastatic Biomarker in Oral Squamous Cell Carcinoma
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Prenatal Detection of Fetal Trophoblasts in Maternal Circulation
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On-Chip in situ mutaFISH™
Mutation Detection without Single Cell Isolation, PCR, WGA, NGS
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mutaFISH™ Sensitivity Compared to dPCR, Nanostring, NGS
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Nucleic Acid Research (2017) 45(8): e59.
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III. WELLCONN DIAGNOSTICS (PRECISION MEDICINE SERVICES)
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CytoQuest™ Workflow
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CytoQuest™ CR
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Certified Medical Personnels
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Man
Wellconn-QP01 組織與管理作業程序
Environment Mechanical
Wellconn-QP15 安全衛生與環境監控作 Wellconn-QP16 設備與試劑耗材管理作
業程序 業程序
懷慷醫事檢驗所
品質系統文件(4M1E)
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Method
Wellconn-QP02 品質管理系統作業程序 Wellconn-QP03 文件管制作業程序 Wellconn SOP-C00 CytoQuest™CR作業標準 Wellconn SOP-C01 CytoQuest CR校正作業標準 Wellconn SOP-C02 CytoQuest CR 試劑檢驗作業 標準
Material
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Wellconn-QP06 供應商評選作業程序
Wellconn-QP16 設備與試劑耗材管理作業程序
Wellconn-QP17 檢體採集與運送管理作業程序
Wellconn-QP18 檢體採集手冊
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Wellconn Customers
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Circulating Tumor Cell Service (1)
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Circulating Tumor Cell Service (2)
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