Alere Technologies GmbH

Transcription

1 Alere Technologies GmbH Mobile Smart Instruments for Automated Image Analysis and Point of Care Diagnosis April 2011 Alere Technologies GmbH

2 Alere Technologies GmbH Based in Jena, Thuringia, Germany ~300 employees Joined Inverness Medical (Alere, Inc.) in 2006 Rebranding from CLONDIAG GmbH to Alere Technologies GmbH (06/2010) ISO13485-certified QM system (03/2010, MDC Germany) Development/manufacture/distribution of multi-parameter tests for professional lab diagnostics and in-vitro diagnostic point-of-care products Alere Technologies GmbH 2

3 Ideal POCT Requirements Suit the needs of the healthcare professional in the field or in the laboratory Affordable, effective and valuable tool in the management of HIV patients. Rapid result within the timeframe of consultation Simple to use Easy to read (trained user) Robust and reliable No cold chain storage conditions Long shelf life reagents Short processing time Portable Independent power source

4 Introduction to Pima CD4 Test Pima is a true point-of-care solution for CD4 testing The platform consists of the Pima Analyser and the Pima test cartridge Designed to equally suit the needs of the healthcare professional in the field and in the laboratory, the Pima Analyser provides an affordable, effective and valuable tool in the management of HIV patients. CE-marked product (end 2009) Alere Technologies GmbH 4

5 Pima CD4 Test Pima Analyser - Features Absolute CD4 count in <20 minutes Mains A/C & Battery powered Portable & Robust Embedded software No External calibration On-board data archive Pima CD4 Test Cartridge - Features Requires only 25μL of capillary or venous whole blood No manual sample handling or processing All reagents sealed in disposable cartridge All dried reagents No cold chain storage Pima CD4 - Product Presentation 5

6 Pima Analyser Interface Features LCD Display Integrated Keypad Cartridge slot door Pima CD4 - Product Presentation 6

7 The Pima CD4 Test Printing Results Results are stored on the analyser and can be printed using the Pima USB printer Pima CD4 - Product Presentation 7

8 Pima Instrument - Background Microscope Head Pima Analyser is a miniaturized, battery powered multi color Fluorescence Microscope on an automated stage It allows for imaging of defined fluorescent signals bound to a surface (or particle) against background The system provides liquid handling capability by peristaltic movement Cartridge Stage with Roller Pima Analyser 8

9 Pima CD4 Cartridge Built-in test controls Reagent QC Device QC Immobilized Cells Barcode QC & Expiry QC Laser Spots Volume QC Contains Assay ID Channel Volume Expiry Date Sample 25µL Pima CD4 - Product Presentation 9

10 Pima CD4 Independent Evaluations The performance of the Pima CD4 test was independently evaluated in different setting on five continents Method comparison to operational studies National reference laboratories to mobile health units Performance of Pima CD4 with both venous and capillary whole blood was shown to be equivalent to the reference method Significantly improved patient retention and time to ART treatment initiation Launched in Europe, several African, AsiaPac, LA countries Pima CD4 - Product Presentation 10

11 Introduction to HIV-NAT Will be a true point-of-care solution for viral load testing The platform consists of an analyser and a test cartridge Designed to equally suit the needs of the healthcare professional in the field and in the laboratory, the HIV-NAT product will provide an affordable, effective and valuable monitoring tool in the management of HIV patients. Alere Technologies GmbH 11

12 Assay Workflow Design Lyse whole blood in the presence of capture molecules with anchor groups Complex of HIV nucleic acids and capture probes with anchor groups is formed (hybridization) Capture complex onto solid matrix (via anchor groups) Remove all unbound material (nucleic acids, proteins, low molecular weight contaminants etc. amplify captured nucleic acids and quantitatively detect the formation of amplified nucleic acids by quantitative real time reporter hybridization PCR 12

13 Instrumentation: Disposable Cartridge 13

14 Instrumentation: The Analyzer For healthcare professional in the field or in the laboratory o Battery powered, Portable & Robust o Embedded software, On-board data archive o No external calibration 14

15 Instrumentation: The Analyzer 15

16 Point-of-Care April 2011 Alere Technologies GmbH