QIAGEN - Evolution from Tool to System Provider in MDx 3 Levels of QIAGEN Product Offering for Different Customer Types

Transcription

1 QIAGEN Molecular Diagnostics Molecular Diagnostics Solutions for Clinical Diagnostic Labs - 1- QIAGEN - Evolution from Tool to System Provider in MDx 3 Levels of QIAGEN Product Offering for Different Customer Types dissemination early adopters specialist labs stand alone tools for prep + PCR OEM prep tools for modular assays stand alone tools for prep + PCR preanalytical modules + assays (PAXgene, artus, Olerup) stand alone tools for prep + PCR preanalytical modules + assays (PAXgene artus, Olerup) mass markets OEM prep modules and assays for integrated systems integrated systems from-tube-to-result yesterday today tomorrow assembled assays bimodular systems integrated systems -2-

2 Towards Integrated Solutions from Tube to Result Combination of Front-end Solutions with artus and HLA Reagents Yesterday Automated Nucleic Acid Purification artus Real-time PCR reagents Analysis Today & Tomorrow From Manual to Automated Solutions

3 Two Pillars That Assure A Quality Result We expect the test used by the laboratory will provide the correct result.. BUT. The quality of the sample used in the test is KING Highest Process Safety with Prefilled Reagents BioRobot EZ1 Important Features 1-6 samples Pre-filled reagents Application Card Benefits Ease of use Standardization & process safety Fast and reliable Highest process safety and ease of use by pre-filled reagents and application cards => Industry standard in Molecular Diagnostics, Biomedical Research and Forensics Application Range RNA Cells and tissues RNA Universal Tissue gdna Blood & tissues Viral Nucleic Acids Haplotype-specific extraction (HLA, CF etc.)

4 BioRobot M48 Low to Medium Throughput Isolates from 6-48 samples/run Time for Nucleic acid isolation 20 min/6 samples hours /48 samples User and Sample safety features Filter tips Drop catcher UV sterilization Hepa filter No cross-contamination (30 & 35 cycle PCR) Largest Application Range for Automated Sample Prep BioRobot Universal System Important Features 96 samples Wide range of applications Sample prep + reaction setup Widest range of applications for sample preparation and assay setup using proven 96-well membrane technology Benefits CFR 21 part 11 compliant Validated, customized and user-developed protocols Multiple application from a single source Application Range RNA Purification from Cells and Tissues PAX Gene RNA Gene Chip Target Preparation gdna Purification (Swabs) Real time PCR assay setup

5 Meeting Regulatory Requirements in MDx and Pharma BioRobot MDx Important Features 24 / 48 / 96 samples CE-IVD compliance (EU) Class I GPR (USA) IQ / OQ / PQ documentation Benefits Primary tube handling Sampling tracking and process reliability and safety LIMS integration capability Easy and standardized High throughput capability (96 samples in 2.5 hrs) Application Range PAXgene RNA gdna from whole blood and buffy coat Viral Nucleic Acids from plasma, serum and cell-free fluids Real time PCR setup Fastest Class I (GPR) system for sample preparation and assay setup in MDx Laboratories QIAGEN LiquiChip

6 artus Real-Time PCR Reagents For the detection of Viruses Bacteria Parasites More then 30 Pathogens in 5 Panels on 3 Platforms Panel Approach for artus Real-Time PCR Assays Transplantation Panel: Viral: CMV, EBV, HSV-1/2, VZV, HHV-6 Fungal: Candida, Aspergillus Respiratory Panel (upper and lower) Viral: Influenza, RSV, Metapneumovirus, Adenovirus, SARS Bacterial: Bordetella, M. pneumoniae, C. pneumoniae, L. pneumophila, M. tuberculosis Encephalitis Panel Viral: HSV-1/2, Enterovirus, West Nile virus, Adenovirus, Parvo B19, Influenza, CMV, EBV Bacterial: Borrelia, M. pneumoniae, M. tuberculosis Gastro-intestinal Panel: Viral: Norwalk-(Norovirus), Rota-, Astrovirus Bacterial: Campylobacter, Salmonella Blood Panel Viral: Parvo B19, HAV, HBV

7 Access to Content from as Many Biological Samples Customized Protocols Validated by QIAGEN s R&D artus PCR Reagents - adapted to Real-time PCR Cyclers22 ABI PRISM artus 3000 / Rotor-Gene LightCycler

8 Most Flexible High Throughput Sample Prep Automation Range of Protocols for All Major Applications Virus Blood Media PAX RNA Custom protocols BioRobot NA Platform rxn setup artus and Homebrew Cycler Sequencer HLA QIAGEN S OLERUP SSP HLA KITS WORLDWIDE MARKET LEADER

9 HLA Product Profile HaploPrep Allele separation: HLA-A HLA-B HLA-C HLA-DRB HLA-DQB SSP HLA typing products WGA Repli-G Number of Kits Available HLA class I 77 HLA class II 30 HLA-A - 20 HLA-B - 36 HLA-Cw 16 A low A direct to high B low C low C direct to high DRA - 1 DRB1-13 DRB3-1 DRB4-1 DRB5-1 DQB1-6 DQA1-1 DPB1-1 DPA1-1 Low DRB, DQB, DQDR

10 Whole Genome Amplification - REPLI-g Whole Genome Amplification: Novel Methods to Overcome the Limitations of Small Amounts of DNA Most Flexible High Throughput Sample Prep Automation Range of Protocols for All Major Applications Virus Blood Media PAX RNA Custom protocols BioRobot NA Platform rxn setup artus and Homebrew HLA Cycler Sequencer

11 Applications Laboratory Manager-PhD Molecular Pathology Sr. Scientist-PhD Molecular Pathology Technologist-Masters in Science Support Field Sales Organization Optimize protocols For unregulated products-troubleshoot For unregulated products-validation of tests Assist with parallel studies **Offer New Customer Trainings** QIAGEN - Automation Capabilities and Reagent Portfolio Address Product Extensions with current extraction customers Maximize current laboratory equipment for downstream labs more profitable Novice lab can start small and grow with QIAGEN solutions for systems and reagents Comprehensive RT Menu on open systems for flexibility and consolidation Worldwide Leader in SSP HLA-fit everywhere With QIAGEN s Technology Leadership and diversified portfolio, we have products to offer most Molecular Labs

12 So how will we be spending our next 6 months Complete the infrastructure process: Built Sales Team to 10 US based and 1 Canadian Based Field Based Molecular Application Specialists 2 US Implementing MDx friendly acquisition programs for systems and reagents Complete regulatory processes-asr certifications Seeking out and securing information on all CLIA certified Laboratories GSA/FSS Securing our HLA accounts with product line extensions-haploprep Pursue ARTUS product line extensions using the panel approach