Bringing Connected Diagnostics to Scale

Bringing Connected Diagnostics to Scale

Connected Diagnostics Opportunity Improve Linkage to Care Reduce Loss to Follow Up Improve Surveillance Reduce Transcription Errors Diagnostics Data Monitor Quality Assurance Reduce Stock Outs Improve Training & HR

Challenge - Fragmented Data Collection Dx1 Portal Dx2 Portal Dx3.. No portal Dx1 Dx2 Dx3

Aggregated View Across Diagnostics DX1 DX1 Portal Useful DX1 info DX2 Portal Useful DX2 info DX2? DX3

CDx: Connected Diagnostics Initiative FIND s expertise is in the domain of diagnostic development and delivery, particularly for infectious diseases. InSTEDD specializes in designing open source, scalable technology tools to solve critical health, safety and development issues. CDx Platform: CDx Initiative: Technology & Services Transmit & store data Multiple diseases, manufacturers Open source Secure, PII privacy Commitment to standards Manufacturer engagement Policy maker engagement Design Advisory Board Ecosystem of field support vendors Evaluation and Research

CDx Platform etc. Device Software Accelerates connecting new devices by manufacturers & 3 rd parties Protocols Open & standardsbased protocols for 2 way communication between devices and servers. See dxapi.org Servers & Services Software that can run in the cloud or your own servers. Aggregates device, result, error and other information 3 rd Party Applications Ecosystem of ehealth & mhealth tools: EMR, ERP, TB Dashboards, HIMS, mobile alerts, etc.

CDx Initiative Areas of Effort Community health worker Health post Hospitals & Labs National health programs Global policy & surveillance A ehealth policy & strategy B Evidence of ehealth impact C D E Centralised data collection, sharing & access Standards & Interoperability Trained resources for ehealth interventions

CDx 1.0 Platform Sneak Peak

CDx Preview Basic Stats

CDx Preview - Errors

CDx Preview Filters & Alerts

Multiple Perspectives

CDx Preview Mapping Results

CDx Preview Workflow Views

CDx Preview Data Sharing

CDx 1.0 - Offering Platform Version 1.0 Q1 2016 Available both cloud & institution-hosted A portfolio of TB diagnostics Technical Assistance CDx server deployment guide User guide GeneXpert Cepheid BACTEC MGIT BD Alere GenoScan Hain Omni Micro Imager Alere-q

Mike Turnlund VP/GM, Engineering & Software Cepheid

Connectivity & Roles in the Ecosystem Centralized, multivendor data systems (EMR, ERP, etc) are best served by ISVs, not device manufacturers Quick integration of secure data streams makes system adoption easier Different roles mean different data needs for institutions and manufacturers Manufacturers: system heuristics, usage, errors Institution: EMRs, epidemiology, logistics CDx allows for quick, uniform, contextual large scale diagnostic system data collection for an institution

Data Streams in a CDX Ecosystem GeneXpert GeneXpert harvests data and Transmits to RemoteXpert RemoteXpert RemoteXpert receives data and securely stores it, generates machine health analysis and alerts Institution X data CDX client transmits formatted data from GX to institution servers Tests run on Heterogeneous lab devices devices transmit cross labs and data in CDX format geos CDX CDX local server receives data and stores it in institution EMR Institution, NGO users log into their servers and use aggregated regional EMR and logistical data

CDx Cepheid Support Cepheid supports integration with many different LIS, EMR, and multi-disciplined ecosystem tools Secure, structured integration with all data systems is vital Quicker, structured integration of comprehensive diagnostics data (not just PCR) frees up resources, accelerates care Cepheid will make available open source clients for it s systems to securely and robustly support data transmission in the CDx format to support the initiative

Anita Suresh Worldwide Mktg Manager, TB Diagnostics BD Diagnostics BD's vision is to enable fully integrated and connected informatics solutions for our diagnostics customers. In TB, this would include realtime reporting, data aggregation and surveillance tools, bringing together diagnostic results across multiple platforms at multiple health settings. BD is partnering with the Connected Diagnostics Initiative to achieve these goals while allowing institutions to customize their solutions to drive clinical impact.

Dr. Dennis Falzon Global TB Programme WHO

MDR TB cases and additional rifampicin resistant TB cases detected (orange) compared with TB cases enrolled on MDR TB treatment (blue), global trend and trend in 27 high MDR TB burden countries, 2009 2014 Global tuberculosis report 2015 (WHO/HTM/TB/2015.22). Geneva, World Health Organization. Geneva, World Health Organization; 2015. www.who.int/tb/publications/global_report/en/

Uses of TB Laboratory Information 1) The requisition, receipt, scheduling and performance of tests 2) The collection and management of samples, and the chain of custody 3) The distribution of test results to clinicians 4) Inventory 5) General laboratory reporting (including billing and contracts) 6) Workload statistics and laboratory performance 7) Surveillance of TB and drug-resistance 8) Human resources development, including training 9) Quality control and external quality assessment processes 10) Laboratory biosafety measures 11) Others (specific to an individual laboratory)

Laboratory Informatics Strengthening TB laboratory informatics important - Laboratory confirmation desirable in both TB/DR-TB patients - Case detection data (TB & DR-TB) are often sourced directly from laboratories - As diagnostics become more advanced even in low resource settings, weaknesses in information management become more pronounced - Better informatics offer other potential to improve care and laboratory performance.

Connected diagnostics : a logical first step in the development of TB laboratory informatics WHO/ERS. Digital health for the End TB Strategy: an agenda for action. (WHO/HTM/TB/2015.21). Geneva, World Health Organization; 2015.

Extensive Existing & Planned Clients Increasing coverage of common ehealth & mhealth solutions From self-contained to national scale Promiscuous interoperability a core goal

2016 Efforts CDX Advisory Board Additional Manufacturer Support Implementations Research & Evidence

Thank you For further information please visit cdx.io