Alere q A Molecular Platform for Global Health Diagnostics

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1 Alere q A Molecular Platform for Global Health Diagnostics Glenn Johns, Ph.D. Director, Global Health Diagnostics R&D 6 th Advanced Course on Diagnostics Annecy, France September 9, 2015

2 Alere q Complete Alere q External Battery Connectivity Module USB Printer Disposable Cartridge Compact and portable platform which delivers molecular results at the Point of Care 2

3 Alere q HIV-1/2 cartridge Sample Capillary Air channel Washing buffer Reagent chamber * Amplification and detection reagent includes specific primers and reporters Control window Lysis chamber * Capture reagent contains specific capture probe Reactor chamber * Probe array with specific probes & probes accommodating controls incl. IPC detection Waste Buffer Reservoir * modifications made to the current Alere q HIV-1/2 test for accommodating an Filovirus test on the Alere q cartridge

4 CMA: Array-Layout and Threshold Cycle Detection HIV-1_group O HIV-1_group M/N Index spots for alignment of an analysis grid Probes for HIV1 group M/N and group O and HIV2 Armored RNA internal process controls for HIV-1 and HIV-2 Positive/negative hybridization controls Change in signal Intensity indicates improper test run 4

5 Alere q HIV 1/2 Test Characteristics Intended Use Test Target Analyzer Instrument Sample Specimens Total steps required Diagnosis of HIV Infection (Detect) including Early Infant Diagnosis (EID) and monitoring of VL (VL WB, VL P) in HIV-positive patients Unspliced RNA of HIV-1 (M,N,O) and HIV-2 in whole blood or EDTA plasma Portable device <5kg weight; 20cmX20cmX29cm (W/H/L), no maintenance or calibration required Capillary whole blood, venous blood (EDTA) or EDTA plasma WB tests do not require any sample handling or pre-treatment by user Plasma test requires only plasma separation Alere q HIV 1/2 Detect Test Limit of Detection for 25µL sample 2491 cp/ml for HIV-1M [ cp/ml] 943 cp/ml for HIV-1O [ cp/ml] 952 cp/ml for HIV-2 [ cp/ml] Diagnostic Specificity >99% HIV tests In the pipeline: Alere q HIV 1/2 WB VL Test Longitudinal studies to demonstrate clinical utility of fingerstick whole blood as sample Diagnostic Sensitivity >99,5% for HIV-1M ( 4000 cp/ml) 100% for HIV-2 ( 4000 cp/ml) Alere q HIV 1/2 Plasma VL Test 5

6 Alere q Pipeline: TB Detect and DST Profile 6

7 Microscopy Center Conditions 7

8 Conditions at Microscopy Centers Denkinger et al. Expert Rev. Mol. Diagn. 13(8), (2013). Denkinger et al. Eur Respir J 2013; 42:

9 Alere q TB MDx Test Components Sputum Cup TB Detect Alere q Instrument Platform TB DST Profile 9

10 Workflow of the Alere q TB Detect test 10

11 Alere q TB DST Profile reflex test strategy 11

12 Alere q TB DST Profile reflex test strategy 12

13 Alere q DST Profile test design Multiplex assay for detection of SNP s associated with resistance to rifampin (rpob hot spot), isoniazid (katg) fluoroquinolones (gyra) and pyrazinamide (pnca) Probes representing wild type for all targets Probes representing corresponding mutations (RIF, INH, FQ) Additional probes for phylogenetic/silent SNP s within pnca Probe for control of MTB presence Probe for detection of fully integrated internal process control 13

14 signal signal Data processing for SNP resistance detection 1 Wild type 0,8 0,6 0,4 516wt_v03 516Val_v03 516Tyr_v03 0, temperature [ C] 1 0,8 0,6 0,4 Wild type 526wt_v03 526Asp_alt 526Tyr_alt 0, temperature [ C] 14

15 Alere Data Point Connectivity Analyzer 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 analyzers 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 to alert program administrators to activity that is of interest to them on a near real-time or scheduled basis. 15 CONFIDENTIAL 15

16 Thank You!