Welcome to the fully integrated autoimmune laboratory. Saves time by reducing hands-on functions NOVA Lite Barcoded IFA Slides

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1 The Integrated Lab Connected Welcome to the fully integrated autoimmune laboratory. Saves time by reducing hands-on functions NOVA Lite Barcoded IFA Slides NOVA View Reduces costs with automation efficiencies Maximizes workflow with data-driven integration QUANTA-Lyser Creates a transcription free, paperless environment Optimizes quality control with centralized analysis BIO-FLASH QUANTA Link

2 The Integrated Lab Data Driven Workflow and Cost Efficiency What is the Integrated Lab? A complete portfolio of Inova instruments seamlessly connected by a central data management system that efficiently integrates the autoimmune laboratory s functional testing areas to increase productivity, improve sample integrity, optimize quality control and generate overall cost reductions. NOVA Lite IFA Slides Contain smart barcodes that connect patient samples to a well location. NOVA View * An automated microscope that analyses each well and creates a digital image for technical review. QUANTA-Lyser An automated EIA/IFA slide processor capable of reading IFA slide barcodes. QUANTA Link Seamlessly integrates instruments with your LIS to efficiently manage workflow and quality control. BIO-FLASH Fully automated random access chemiluminescent benchtop analyzer for autoimmunity. * NOVA View is not available for sale in the U.S.

3 Inova Diagnostics Considerations for Integration Efficient Workflow An integrated data management environment for better throughput Quality Control Optimized QC with real-time trending and analysis Positive Patient ID Barcoded slides and centralized data input improves sample traceability Error-free Transcription Eliminates transcription errors in sample processing and analysis Increased Productivity Reduced hands-on time improves throughput Seamless Integration Efficiently integrates into any LIS for immediate control Laboratory workflow comparison The traditional lab Functional areas operate independently, without the ability to easily exchange data. The Inova Integrated Lab Improved productivity in a data driven environment with volume matched to instrument configurations that generate automation efficiencies IFA Autoimmune IFA Autoimmune Assays EIA Assays Assays EIA Assays Inova Integrated Lab Autoimmune Chemiluminescent Assays Esoteric EIA Autoimmune Chemiluminescent Assays Esoteric EIA Independent instrument configuration INOVA instrument configuration with QUANTA Link data management

4 Integrated Processing Automated EIA/IFA Analyzer Platform QUANTA-Lyser Flexibility and efficiency The QUANTA-Lyser family of instruments is the most flexible and efficient platform for EIA and IFA processing, with three different models to meet the volume requirements of any laboratory. QUANTA-Lyser is a walk-away automated system that communicates effortlessly with QUANTA Link to improve workflow efficiencies and quality control. QUANTA-Lyser 160/240 Holds up to 6 EIA plates or 30 IFA slides 4 independent ceramic coated pipette tips QUANTA-Lyser 160 holds up to 160 samples per run, and is configured to maximize the number of analytes per run. QUANTA-Lyser 240 holds up to 240 samples per run, and is configured to optimize sample throughout

5 QUANTA-Lyser Washable ceramic coated pipette tips reduce cost Rapid Processing Speed Increases throughput independent four probe system provides fast sample/reagent processing Reduces Cost Washable ceramic pipettes eliminate disposable tips and reduce waste Assay Integrity Confirms that the sample worklist and substrate are matched correctly for IFA Screen Alert An on-screen alert informs the operator if the slide substrate does not match the worklist or if a slide barcode is scanned twice QUANTA-Lyser 2 Compact and flexible Holds up to 2 EIA plates or 15 IFA slides Holds up to 96 samples per run One ceramic coated pipette tip Ideal platform for esoteric assays or in settings that require maximum flexibility and efficiency

6 Integrated Analysis Automated Analysis with Positive Patient ID NOVA View Digital IFA A new paradigm in IFA analysis and automation using digital technology and proprietary algorithms to capture light intensity and create digital images for review. Coupled with QUANTA Link data management and NOVA Lite barcoded slides, NOVA View increases productivity while helping provide more consistent results. Shows mitotic images NOVA Lite IFA Barcoded Slides Barcoded slides enable seamless laboratory workflow by tracking patient data from sample preparation to result.

7 NOVA View Delivering positive patient identification Prompts Analysis Samples can be arranged by positive or negative intensity for easier review Reduces Hands-on Time Fully automated slide review and image acquisition Positive Patient ID Is ensured by scanning the IFA slide barcode, and data is entered directly into the screen for transfer to the LIS Increases Productivity Image review and reporting can be scheduled any time after analysis Supports Standardization Quantitative algorithms facilitate analysis and help reduce variability NOVA View analysis and pattern recognition algorithms DAPI, a blue fluorescent stain, is used to locate a minimum number of cells and to identify the location of each nuclei DAPI helps differentiate between background and nuclear intensity This process provides a quality check for the presence of cells when FITC intensity is negative Actual NOVA View images DAPI FITC FITC/DAPI Overlay Algorithm Analysis NOVA View pattern recognition algorithms are analogous to a 3-D holographic picture. The algorithm directly measures the peaks and valleys of each image and proposes a pattern for confirmation by the operator. Speckled Pattern Homogeneous Nucleolar and Nuclear Dot patterns not shown Centromere

8 Integrated Technologies Progressive Solution to Common Problems BIO-FLASH Rapid-Response Chemiluminescent Analyzer for Autoimmunity BIO-FLASH is a full menu, random access analyzer that eliminates batching and has excellent throughput with up to 450 results in a single shift. BIO-FLASH offers precise quantification and a broad dynamic range using chemiluminescent technology, onboard reagents and stable calibration curves to make even the most specialized testing easy to perform.

9 Inova Diagnostics Full menu random access Eliminates isotype batching and reagent waste Stable on-board reagents allow for samples to be run as they arrive Improves turn-around time Simultaneous random access processing of all isotypes and assays on a single sample Helps reduce test send outs Makes even the most specialized assays efficient to perform with stable calibration curves Frees up floor space Small benchtop analyzer achieves excellent throughput QUANTA Flash reagents Chemiluminescent technology delivers precise quantitation and a broad analytical measuring range Cartridge barcode is internally scanned to import the master calibration curve, lot number, expiration date and assay type RLU 230k * 200k 170k x 140k 110k * 90k 60k 30k * 0 x * ** IU/mL Calibration curves Master calibration curve uploaded through the reagent pack barcode Calibrators are processed in the sample carousel BIO-FLASH determines a stable working calibration curve Intuitive software and touchscreen Simplifies training and day-to-day operation Status screen allows immediate access to system information

10 Integrated Workflow Data-Driven Laboratory Management QUANTA Link Workflow Management Made Easy A powerful, easy-to-use workflow management system that gives you immediate control of all your autoimmune sample processing. From worklist generation and result confirmation to quality control and data search functions, this LIS compatible system maximizes laboratory productivity and profitability. Command Central Color coded bars allow you to view and determine workflow priorities for the entire lab on a single screen. Reflex rules can be added at each decision point

11 QUANTA Link Paperless Interpretation Atlas QUANTA Link transforms your dark room into a paperless, transcription free environment. Simply enter the information directly on the touch screen. User defined atlas used for reference and training. Optimize Quality Control Multi-Analyte Screen All quality control information centralized in a single location by using Levey-Jennings and employing Westgard rules. Allows the technologist to view ANCA Ethanol, ANCA Formalin and HEp-2 results from the same patient simultaneously.

12 Integrated Lab Seamless control from processing to reporting NOVA Lite IFA Barcoded Slides QUANTA Link NOVA View QUANTA-Lyser BIO-FLASH Workflow management made easy Digital IFA Flexibility and efficiency Rapid-Response Chemiluminescent Positive Patient ID Analyzer for Autoimmunity Powerful easy-to-use workflow management system that gives you immediate control of all your autoimmune sample processing. A new paradigm in IFA analysis and automation using digital technology and proprietary algorithms to capture light intensity and create digital images for review. The QUANTA-Lyser family of instruments is the most flexible and efficient platform for EIA and IFA processing, with three different models to meet the volume requirements of virtually any laboratory. BIO-FLASH is a full menu, random access analyzer that eliminates batching and has excellent throughput with up to 450 results in a single shift. Seamlessly integrate Inova instruments Positive patient to the LIS identification for IFA samples Efficiently controls instrument workflow Eliminates the need for transcription Effectively manages test and associated errors orders and results Reduces hands-on Optimizes quality time with automated control through analysis trending and analysis Eliminates the need for batching Fully automated, Faster turnaround walk-away system to time with continuous minimize hands-on time loading Rapid processing Calibration curve speed maximizes remains stable for throughput and each reagent lot increases productivity Probe washer eliminates disposable tips generating significant cost savings San Diego, CA USA PH: US Toll Free: FAX: BIO-FLASH is a registered trademark of Biokit, S.A. QUANTA Link, QUANTA-Lyser, NOVA View, NOVA Lite and QUANTA Flash are registered trademark of Inova Diagnostics, Inc Inova Diagnostics, Inc. All rights reserved October 2014 Rev. 0 Barcoded slides enable seamless laboratory workflow by tracking patient data from sample preparation to result. Sample integrity is maintained using unique numeric codes to link each patient to a single well Assay integrity is assured from sample processing to analysis

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