Alere q. A platform to answer global health needs: TB and beyond. Duncan Blair Director, Public Health Initiatives

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1 Alere q A platform to answer global health needs: TB and beyond Duncan Blair Director, Public Health Initiatives 7 th FIND Symposium, Barcelona, October 2014

2 Alere q platform overview Comprising the Alere q analyser & the Alere q cartridges the system provides molecular diagnostics capability in a true point-of-care package Workflow Portable, battery operated Data connectivity enabled Primary samples collected directly into the assay disposable User inserts cartridge into analyser, enters ID data for full walk-away operation 100% automated processing by the Alere q analyser. Sample extraction, target purification, amplification and microarray-based detection Results are stored on the device and can be printed, exported via ethernet, USB or GPRS mobile modem

3 TB assay design goals and philosophies A molecular TB diagnosis and DST solution for true point of care use. Zero manual sample manipulation steps, zero additional consumables or reagents and unparalleled ease of use with walk away operation to facilitate task shifting and greatly expanded access 100% sample collection, processing, amplification and detection integrated into a single disposable No complex procedures, minimal qualification and training requirements Walk away operation High sensitivity, high specificity Rapid case detection (<20 min) and reflex DST (<40 minutes) from single specimen Facilitate decentralisation and task shifting to enable far greater access to treatment initiation

4 Fully-Automated Workflow for TB Diagnosis Custom sputum cup Processing, amplification and detection

5 Fully-Automated Workflow for TB Diagnosis

6 Fully-Automated Workflow for TB Diagnosis 1. Sputum liquefaction and homogenization

7 Fully-Automated Workflow for TB Diagnosis 2. Nucleic acid purification and mycobacterial DNA enrichment

8 Fully-Automated Workflow for TB Diagnosis 3. Reagent reformulation and reaction setup

9 Fully-Automated Workflow for TB Diagnosis 4. Nucleic acid amplification and real-time detection

10 Reflex DST testing No new specimen required PCR and array based detection with rapid results (<40 min) Rifampicin Isoniazid Fluoroquinolones Potentially pyrazinamide

11 Intended use setting Level 4 National Reference Labs Level 3 Regional Reference Labs Level 2 District Labs and Hospitals Level 1 Microscopy Centers and Community Health Clinics Infrastructure Complexity Potential TB Patients Served

12 Intended use setting

13 Intended use setting

14 A highly versatile, adaptable system Two basic cartridge designs, low volume and high volume Molecular assays based on multiple amplification chemistries Microarray based detection High volume cartridge Low volume cartridge Actual images from Alere q analyser Low density array assay High density array assay

15 Alere q system assay development targets HIV1/2 Detect launched July 2014 HIV1/2 Viral Load launching late 2014, early 2015 TB Detect and reflex TB DST in advanced development, going into extensive clinical trials 2015, CE IVD marking and commercial launch by Q HCV viral load Infectious disease panels Many additional possibilities

16 Alere Data Point Connectivity Analyser USB Modems Alere SIMs Alere Data Point Portal Data Point Connectivity offering Data Point is the connectivity package that delivers analyser results to a central server enabling customers to access data remotely via the Data Point portal. Regardless of how many analysers are in the field the portal allows near real-time monitoring of data including usage patterns, device condition & stock management. The portal is also enabled with a flexible reporting & alerting system allowing program administrators to be alerted to activity that is of interest to them on a near real-time or scheduled basis. CONFIDENTIAL 16

17 Implementation Capabilities: Our Global Footprint With 40+ affiliate offices and representation in over 100 countries worldwide our commercial teams and distribution partners are key to delivering sustainable diagnostic solutions to the market Represented In >100 countries Total Employees 18,000

18 Implementation: Public Private Partnerships Alere partners with ministries of health to provide teams of Field Support Staff to facilitate high quality point of care diagnostic testing Alere pays for and trains ministry-seconded Field Support Staff FSS assist other MoH staff with trouble shooting, training, mentoring, quality management, policy/guideline updates, linkage to care and more Programs functional in Uganda, Zambia and South Africa MoUs in development with Zimbabwe, Côte d Ivoire and Cameroon. Additional program expansion expected.

19 Acknowledgements Glenn Johns Ines Labugger Eugen Ermantraut Alere Technologies Free State of Thuringia