Alere™ qA platform to answer global health needs:TB and beyond

Duncan BlairDirector, Public Health Initiatives

7th FIND Symposium, Barcelona, October 2014

• 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

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

• 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

TB assay design goals and philosophiesA 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

Fully-Automated Workflow for TB Diagnosis

Custom sputum cup Processing, amplification and detection

Fully-Automated Workflow for TB Diagnosis

Fully-Automated Workflow for TB Diagnosis

1. Sputum liquefaction and homogenization

Fully-Automated Workflow for TB Diagnosis

2. Nucleic acid purification and mycobacterial DNA enrichment

Fully-Automated Workflow for TB Diagnosis

3. Reagent reformulation and reaction setup

Fully-Automated Workflow for TB Diagnosis

4. Nucleic acid amplification and real-time detection

• No new specimen required

• PCR and array based detection with rapid results (<40 min)

• Rifampicin

• Isoniazid

• Fluoroquinolones

• Potentially pyrazinamide

Reflex DST testing

Intended use setting

Level 4

Level 3

Level 2

Level 1

Potential TB Patients Served

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National Reference Labs

Regional Reference Labs

District Labs and Hospitals

Microscopy Centers and Community Health Clinics

Intended use setting

Intended use setting

• Two basic cartridge designs, low volume and high volume

• Molecular assays based on multiple amplification chemistries

• Microarray based detection

A highly versatile, adaptable system

Actual images from Alere q analyser

Low density array assay High density array assay

High volume cartridge

Low volume cartridge

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 Q4 2015

• HCV viral load

• Infectious disease panels

• Many additional possibilities

Alere Data Point Connectivity

CONFIDENTIAL | 16

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.

Alere Data Point PortalAlere SIMsUSB ModemsAnalyser

Implementation Capabilities: Our Global FootprintWith 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

Total Employees18,000

Represented In>100 countries

Implementation: Public Private PartnershipsAlere 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.

http://alerehiv.com/video/alere-field-support-staff-in-uganda/

Acknowledgements

Glenn Johns Ines Labugger Eugen Ermantraut

Alere Technologies

Free State ofThuringia