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1 INOVA Diagnostics

2 DISTRIBUTORS

4 INOVA is a dedicated R&D company Facilities: square feet INOVA employs 200 people at its San Diego facility More than 60 employees are R&D scientists and are directed by former president Dr. Binder who remains as CTO New biomarkers are published in peerreviewed journals and posters in autoimmunity congresses

5 +100 products with FDA & CE +12 new products under FDA review during 2008 First commercially available or FDA-cleared Inova at the Market autoimmune diagnostic tests

6 INOVA product lines Rheumatoid arthritis 自身免疫性风湿性疾 Celiac disease 自身免疫性腹腔疾病 Coagulation (Lupus anticoagulants ) 抗磷脂类疾病 (APS) Endocrine, autoimmune liver disease related infectious disease 内分泌和自身免疫性肝炎 Gastrointestinal disorders 自身免疫性胃肠病 Connective tissue disease 自身免疫性结缔组织疾病 Vasculitis 自身免疫性脉管疾病

7 INOVA test formats 酶联免疫吸附 IFA GEL 间接免疫荧光双扩 Luminex 液相芯片 Chemiluminescence 化学发光

8 INOVA product lines 自身免疫性风湿性疾病检测抗体英文缩写临床意义检测方法抗环瓜氨酸肽抗体 3 抗环瓜氨酸肽抗体 3.1 CCP3 IgG CCP3.1 IgG and IgA RA RA 的早期诊断抗类风湿因子 IgG RF IgG(66%) 正常人(2-10%) 自身免疫性疾病及其它多种疾病 RF 均可阳性, 对 RA 只有相对特异性, 高滴度 RF 对 RA 诊断特异性高抗类风湿因子 IgM RF RA:IgM(92%) 抗类风湿因子 IgA RF IgA(65%); 抗环瓜氨酸肽抗体 CCP RA 特异性抗体, 敏感性 63%~76 %, 特异性 96% 以上 ;RA 早期诊断, 判断疾病活动性及预后的指标

9 INOVA product lines 自身免疫性结缔组织疾病检测抗体英文缩写临床意义检测方法抗 SS-A 52 抗体 SS-A 52 52KD 的抗 SSA/Ro 抗体多见于 SLE(30 %), 尤其是亚急性皮肤型 SLE(SCLE) 抗 RNA 聚合酶抗体 RNA Pol III SSC, 肾病抗双链 DNA 抗体 dsdna SLE 特异性抗体, 诊断标准之一 ;SLE 阳性率 : 活动期阳性率 80%~100%, 非活动期 <30%;SLE 活动性标志抗组蛋白抗体 AHA (Histone) 多种 CTD 中出现, 不具诊断特异性, 仅有此抗体, 而不伴有其它 ANA( 抗 ssdna 抗体除外 ), 则强烈支持 DIL 诊断抗单链 DNA 抗体 ssdna 非特异性抗体,SLE(70-95%),DIL (60%),MCTD(20-50%),PM/DM (40-50%),RA SS SSc(8-14%)

10 INOVA product lines 抗 ( 盐水 ) 可提取性核抗原抗体 4 项 ENA 抗 Sm 抗 SSA/Ro (52, 60) 抗 SSB/La SLE 血清标记抗体 (20%-40%),SLE 早期不典型回顾性诊断指标主要见于 pss(60%-75%), 也见于 SLE(20% -60%) SSc RA PM PBC 主要见于 pss(10%-40%), 也见于 SLE(10% -20%) 新生儿及亚急性皮肤狼疮抗核 RNP 高效价抗体为 MCTD 特征, 阳性率 95%-100% 抗 Sm Sm SLE 血清标记抗体 (20%-40%),SLE 早期不典型回顾性诊断指标抗核 RNP RNP 高效价抗体为 MCTD 特征, 阳性率 95%-100% 抗 SSA/Ro (52,60) SSA/Ro 主要见于 pss(60%-75%), 也见于 SLE(20% -60%) SSc RA PM PBC 抗 SSB/La SSB/La 主要见于 pss(10%-40%), 也见于 SLE(10% -20%) 新生儿及亚急性皮肤狼疮抗 Scl-70 Scl-70 SSc 血清标记抗体, 阳性率 25%-75% 抗 Jo-1 Jo-1 PM/DM 血清标记抗体, 阳性率 20%-60%, 纤维化肺泡炎, 关节炎

11 INOVA product lines 抗核糖体 P(Rrnp) P(Rrnp) SLE 特异性抗体 (10-40%), 与中枢神经系统肝脏或肾脏受累相关, 常在 SLE 活动期存在, 狼疮脑病 (50-90%) 抗 ( 盐水 ) 可提取性核抗原抗体 ENA 5 项 Sm,RNP, SSA/Ro,SSB/La Scl-70 筛查 SLE 及其他 CTD 抗 ( 盐水 ) 可提取性核抗原抗体 ENA 6 项 Sm,RNP, SSA/Ro,SSB/La, Scl-70 Jo-1 筛查 SLE 及其他 CTD 抗染色体抗体 Chromati (Nucleosome) SLE, DIL(drug induced lupus) 抗核抗体 ANA 自身免疫性疾病筛选试验抗着丝点抗体 Centromere SSc(30%),CREST 综合征 (50-80%), 原发性雷诺现象 (25%),PBC(10-20%) SLE 8 项检测系统 Sm,RNP, SSA/Ro 52, SSA/Ro 60, SSB/La,Scl-70 Jo-1,Rrnp chromatin SLE, SS, PM, Scleroderma( 硬皮病 ) Luminex

12 INOVA product lines 抗磷脂类疾病 (APS) 检测抗体英文缩写临床意义检测方法抗心磷脂抗体筛查 ACA (acl) SLE(30-40%), 常同反复动静脉血栓血小板减少和习惯性流产相关, 抗磷脂综合征 (APS) 诊断指标抗心磷脂抗体 IgG 抗心磷脂抗体 IgM 抗心磷脂抗体 IgA 抗 β2 糖蛋白 Ⅰ 抗体筛查抗 β2 糖蛋白 Ⅰ 抗体 IgG 抗 β2 糖蛋白 Ⅰ 抗体 IgM 抗 β2 糖蛋白 Ⅰ 抗体 IgA β2-gpi 常同反复动静脉血栓血小板减少和习惯性流产相关, 抗磷脂综合征 (APS) 诊断指标定性

13 INOVA product lines 自身免疫性脉管疾病检测抗体英文缩写临床意义检测方法抗髓过氧化物酶抗体 MPO 主要与显微型多动脉炎 (MPA) 坏死性新月体肾小球肾炎 (NCGN) 过敏性肉芽肿性血管炎 (CSS) 结节性多动脉炎 (PAN) 抗肾小球基底膜疾病 ( 抗 GBM 病 ) 等相关与病情活动相关, 也可用于判断疗效估计复发和指导疗效 WG(10%) MPA(45%) NCGN(65%) CSS(60%) PAN(15%) GBM 病 (30%) 抗蛋白酶 3 PR3 韦格纳氏肉芽肿 (WG) 特异性自身抗体, 特异性大于 95%; 敏感性取决于疾病的活动性和病期阶段, 阳性率 50%-100% 抗体滴度与病情活动一致, 常被作为判断疗效估计复发的指标抗肾小球基底膜抗体 / 抗肾抗体抗中性粒细胞胞浆抗体 GMB 抗肾小球基膜肾炎 (Goodpasture 综合症 ) 诊断和鉴别诊断,Goodpasture 综合症 (100%), 肾肺综合症 (15-20%) ANCA 原发性系统性血管炎 (WG MPA NCGN CSS PAN) 诊断及鉴别诊断 ; 炎症性肠病 (UC CD) 自身免疫性肝病辅助诊断指标 IFA

14 INOVA product lines 自身免疫性消化系统疾病自身免疫性胃病检测抗体英文缩写临床意义检测方法抗幽门螺旋杆菌抗体 (IgG) H. pylori (IgG) 幽门螺旋杆菌感染和其他胃肠性疾病抗幽门螺旋杆菌抗体 (IgA) H. pylori (IgA) 幽门螺旋杆菌感染和其他胃肠性疾病抗胃壁细胞抗体 GPA 恶性贫血抗内因子抗体 IFA 自身免疫性胃炎诊断和鉴别诊断, 阳性率 (30-50%), 特异性较高, 多伴恶性贫血

15 INOVA product lines 自身免疫性腹腔疾病检测抗体英文缩写临床意义检测方法抗平滑肌 F-Actin 抗体 IgA F-Actin IgA 小肠绒毛状萎缩, 自身免疫性肝炎抗麦胶蛋白抗体 II (IgG) DGP (IgG) 腹腔疾病, 麦胶 ( 麸质 / 谷物 ) 过敏性肠病诊断和鉴别诊断抗麦胶蛋白抗体 II (IgA) DGP (IgA) 腹腔疾病, 麦胶 ( 麸质 / 谷物 ) 过敏性肠病诊断和鉴别诊断抗麦胶蛋白抗体筛查抗人类组织谷酰转胺酶抗体筛查抗人类组织谷酰转胺酶抗体和抗麦胶蛋白抗体筛查 DGP (IgG) DGP (IgA) h-ttg (IgG,, IgA) DGP (IgG) DGP (IgA) h-ttg (IgG,, IgA) 麦胶 ( 麸质 / 谷物 ) 过敏性肠病诊断和鉴别诊断和疱疹样皮炎麦胶 ( 麸质 / 谷物 ) 过敏性肠病诊断和鉴别诊断和疱疹样皮炎 IgA 过多或缺陷的腹腔疾病 IgA 过多或缺陷的腹腔疾病和疱疹样皮炎抗麦胶蛋白抗体 (IgG) DGP (IgG) 麦胶 ( 麸质 / 谷物 ) 过敏性肠病诊断和鉴别诊断和疱疹样皮炎抗麦胶蛋白抗体 (IgA) DGP (IgA) 麦胶 ( 麸质 / 谷物 ) 过敏性肠病诊断和鉴别诊断和疱疹样皮炎

16 INOVA product lines 抗肌内膜组织谷酰转胺酶抗体 ttg (IgA) 麦胶 ( 麸质 / 谷物 ) 过敏性肠病诊断和鉴别诊断和疱疹样皮炎抗人类组织谷酰转胺酶抗体 (IgA) h-ttg (IgA) 麦胶 ( 麸质 / 谷物 ) 过敏性肠病诊断和鉴别诊断和疱疹样皮炎抗人类组织谷酰转胺酶抗体 (IgG) h-ttg (IgG) 麦胶 ( 麸质 / 谷物 ) 过敏性肠病诊断和鉴别诊断和疱疹样皮炎抗人类组织谷酰转胺酶抗体和抗麦胶蛋白抗体检测系统 DGP (IgA) h-ttg 麦胶 ( 麸质 / 谷物 ) 过敏性肠病诊断 Luminex

17 INOVA product lines 肠炎性自身免疫性疾病检测抗体英文缩写临床意义检测方法抗外膜蛋白抗体 IgA OPM IgA 与抗酿酒酵母抗体一起使用诊断 Crohn's disease 局限性肠炎抗酿酒酵母抗体 IgG 抗酿酒酵母抗体 IgA ASCA IgG Crohn's disease 局限性肠炎 ASCA IgA Crohn's disease 局限性肠炎

18 INOVA product lines 自身免疫性肝炎检测抗体英文缩写临床意义检测方法抗线粒体抗体亚型抗体分型原发性胆汁性肝硬化 (PBC) 筛查 IgG/IgA 抗肝 / 肾微粒体 1 型抗体抗可溶性肝抗原抗体 M2 AMA, gp210, Sp-100 LKM-1 SLA 原发性胆汁性肝硬化 (PBC) 诊断和鉴别诊断,PBC: M2(98%) 自身免疫性肝炎 (AIH) 诊断和鉴别诊断,Ⅱ 型 AIH 血清学标志自身免疫性肝炎 (AIH) 诊断和鉴别诊断,Ⅲ 型 AIH 血清学标志抗肌动蛋白抗体 Actin AIH, PBC 抗 Sp-100 抗体 Sp-100 常见于 PBC(6-44%), 常与 AMA 同时出现 ; 亦常见于 SS 自身免疫性疾病, 如 SSc(7%) SLE(2%) MCTD 等抗 gp210 抗体 gp210 PBC 高特异性自身抗体, 特异性高达 99%, 在其他患者中如 AIH 风湿性疾病 PM/DM 或 pss 中很少见, 在 PBC 中的敏感性可达 10%-41%

19 INOVA product lines 自身免疫性甲状腺疾病检测抗体英文缩写临床意义检测方法抗甲状腺球蛋白抗体抗甲状腺过氧化物酶抗体抗甲状腺微粒体, 胶体抗体, 抗甲状腺球蛋白抗体其他产品 TGA 自身免疫性甲状腺和原发性甲减的诊断中有重要价值, 对格雷夫斯病的诊断特异性. 桥本甲状腺炎 (Hashimoto s Thyroitis) TPO 自身免疫性甲状腺炎最佳标志抗体, 常见于桥本甲状腺炎 (95-100%) Granes(70%) 产后甲状腺炎甲减等 TMA TGA TCA 自身免疫性甲状腺和原发性甲减的诊断中有重要价值 IFA 抗皮肤抗体 SA 自身免疫性皮肤病诊断, 特别是天疱疮和类天疱疮 IFA

THE PERFECT SIZED SOLUTION SPECIALTY LABS COMMUNITY HOSPITALS ACADEMIC HOSPITALS CLINICAL REFERENCE LABS Pipette BIO-FLASH CHEMILUMINESCENCE (under development) IFA DS2 ASP 1200

20 THE PERFECT SIZED SOLUTION SPECIALTY LABS COMMUNITY HOSPITALS ACADEMIC HOSPITALS CLINICAL REFERENCE LABS Pipette BIO-FLASH CHEMILUMINESCENCE (under development) IFA DS2 ASP 1200 Washer Ouchterlony Microscope Reader QUANTA LYSER 2 Best 2000 / DSX QUANTA LYSER 160 QUANTA LYSER 240 Ouchterlony MANUAL IFA SEMI- AUTOMATED IFA +IFA AUTOMATED IFA +IFA IFA +IFA THROUGH-PUT

21 Olympus CX 31 Olympus CX 31 Microscope: Highlights Microscope with integrated binocular tube 30/20, 4x revolving nosepiece, transmitted light illumination with 6 volt 30 watt halogen bulb, integrated power unit volt, A.F.T.E.R. Easy Blue: High efficiency illuminator for transmitted light fluorescence with power supply, blue LED cassette with excitation wavelength 480 nm best for FITC and GFP wild type. Superior power LED source vs. mercury or xenon lamps, 30,000 hrs Where should we place these units? Any Customers who run IFA testing is potential candidate for CX 31 microscope.

22 Semi Automation Platforms Elisa Stat Fax Washer and Reader: Highlights: Stat Fax 2600 plate washer Full automatic washing 8 probe manifold wash Up to 50 programmable wash protocols 3 Wash bottle capacity, aerosol shield No user adjustment, automatic calibration Stat Fax 3200 plate reader Fully automated reading with _ filter capacity Stores up to 100 user tests On board data reduction and calculations. PC software included NRTL and CE certified Both systems are SIMPLE to install and train.

23 AP-22 FAMILY Only : AP-22 Only IFA: AP-16+ Elisa + IFA: AP-22 SPEEDY IF 2 plate automatic processing system 16 slide automatic IFA processing system 2 Dispensing and aspiration probes Plate washer and reader block Incubator Measuring syringe

24 IFA Instuments-Medium volume A.S.P 1200 Automated ImmunoFluorescence Assay Slide Processor 12 Slide IFA system, (16) 96 Sample capacity with handheld barcoding, 12 controls, 6 reagents slots. Unidirectional interface to download worklists. Automates all stages of the assay processing Sample dilutions (screening and serial), Sample/reagent transfer to slides, Slide washing Can process up to 4 assays simultaneously Walk-away instrumentation, Reliable instrument, Hook and Tucker, over 1000 instruments worldwide. Throughput: 96 samples on HEp-2 slides at 1 screening dilution 2 hour processing time. Save 1 hour and 45 processing time.

25 -Medium throughput DS2 by Dynex 2 plate system 96 Sample capacity with Barcoding, 24 standards, 18 reagents slots Continuous Load up to 12 assay simultaneously. DS Matrix software, Interface capable Small Compact Design, Benchtop Walk-away instrumentation Throughput: 2 plates/2 hours

26 /IFA-Medium throughput Quanta Lyser 2 2 plate, 20 slides /IFA system 96 Sample capacity with Barcoding, 35 cals and controls, 11 reagents slots Fixed Probe, No tip consumable cost Small Compact Design, Benchtop 50 kg Walk-away instrumentation Throughput: 180 tests/ 4 hours, 240 IFA tests/8 hours

27 -High throughput BEST 2000 by Dynex 4 plate system 98 Sample capacity with Barcoding, 33 standards, 24 reagents slots, 1 tip pipette Continuous Load, Flexible Assay Menu, Open system Revelation software, Interface capable, LIS Link Modular Design, Washer, Reader, Incubators, easy to service. Walk-away instrumentation, dynamic timeline Throughput: 6 plates/ 8hours of standard assay, 570 tests/8 hours

28 -High throughput Quanta Lyser 160 and plate system 160 or 240 Sample capacity with barcoding, 64 or 49 cals and controls, 26 or 21 reagents slots, 4 probe capacitance, 4 wash buffers Flexible Assay Menu, Open system GSG/SIAS software, Interface capable, ESP Connect Greater sample capacity and 4 probes increase throughput, Washer, Reader, Incubator, Shaker Walk-away instrumentation, dynamic timeline, Throughput: up to 900 tests/8 hrs

29 IFA Instruments-High Througput Quanta Lyser 160 and 240 IFA 30 Slide system with 5 slide positions, 6 slide supports. 160 or 240 Sample capacity with barcoding, 64 or 49 cals and controls, 26 or 21 reagents slots, 4 probe capacitance, 4 wash buffers Flexible Assay Menu, Open system GSG/SIAS software, Interface capable, Greater sample capacity and 4 probes increase throughput, Washer Walk-away instrumentation, dynamic timeline, Throughput: up 360 tests/4hrs,

30 / IFA-High throughput Quanta Lyser 160 and 240 /IFA 6 plate and 25 Slide system with 5 slide positions, 5 slide supports. 160 or 240 Sample capacity with barcoding, 64 or 49 cals and controls, 26 or 21 reagents slots, 4 probe capacitance, 4 wash buffers Flexible Assay Menu, Open system Both and IFA at the same time Greater sample capacity and 4 probes increase throughput, Washer, Reader, Shaker Walk-away instrumentation, dynamic timeline, Throughput: 450 tests/ 4 hours up to 360 IFA tests/4hrs

31 New technology: Chemiluminescence New technology: Chemiluminescence New Technology: New, fully automated multiparametric immunoassay system Flash chemiluminescence system, Random Access, Batch Mode Autoimmune Menu: 10 core assays Medium Throughput:60 tests/hour Next Generation: Track, Module, greater capacity

32 BIOFLASH: Chemiluminescence 30 Sample capacity with barcoding, 20 onboard reagents slots, 2 probe capacitance, disposable cuvettes Sample pre dilution and post, Reflex tests Incubation 37 o C Detector: photo multiplier nM Walk-away instrumentation, dynamic timeline Growing Assay Menu Throughput: up 240 tests/4hrs,

33 THE PERFECT SIZED SOLUTION SPECIALTY LABS COMMUNITY HOSPITALS ACADEMIC HOSPITALS CLINICAL REFERENCE LABS Pipette BIO-FLASH CHEMILUMINESCENCE (under development) IFA DS2 ASP 1200 Washer Ouchterlony Microscope Reader QUANTA LYSER 2 Best 2000 / DSX QUANTA LYSER 160 QUANTA LYSER 240 Ouchterlony MANUAL IFA SEMI- AUTOMATED IFA +IFA AUTOMATED IFA +IFA IFA +IFA THROUGH-PUT

34 中国地区战略合作伙伴公司名称广州健仑生物科技有限公司联系电话公司传真电子邮件腾讯 QQ 公司网址营销中心广州市中山大道中 358 号东溪大厦 B 座 511 室公司地址广州市天河区车陂第十五工业园一幢 4067 室

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