Bringing Connected Diagnostics to Scale

Connected Diagnostics Opportunity

Improve Linkage to Care

Reduce Loss to Follow Up

Improve Surveillance Reduce

Transcription Errors

Monitor Quality

Assurance Reduce Stock

Outs

Improve Training & HR

Diagnostics Data

Challenge - Fragmented Data Collection

Dx1 Portal Dx2 Portal Dx3 .. No portal

Dx1 Dx2 Dx3

Aggregated View Across Diagnostics

DX2

DX1

DX3

DX2 Portal

DX1 Portal

?

Useful DX1 info

Useful DX2 info

CDx: Connected Diagnostics Initiative

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

InSTEDD specializes in designing open

source, scalable technology tools to solve

critical health, safety and development issues.

FIND’s expertise is in the domain of diagnostic

development and delivery, particularly for

infectious diseases.

CDx Platform

Accelerates connecting new devices by manufacturers & 3rd parties

Device Software

Open & standards-based protocols for 2 way communication between devices and servers. See dxapi.org

Protocols

Software that can run in the cloud or your own servers. Aggregates device, result, error and other information

Servers & Services

Ecosystem of ehealth & mhealth tools: EMR, ERP, TB Dashboards, HIMS, mobile alerts, etc.

3rd Party Applications

etc….

Trained resources for eHealth interventions

CDx Initiative Areas of Effort

Hospitals

& Labs Health post Community

health

worker

eHealth policy & strategy

Evidence of eHealth impact

Standards & Interoperability

Centralised data collection, sharing & access

A

B

D

C

E

National health

programs

Global policy

& surveillance

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

Omni

BACTEC

MGIT

GenoScan

Cepheid Alere

Alere-q

BD

Micro Imager

Hain

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 harvests data and Transmits to RemoteXpert

CDX local server receives data and stores it in institution EMR

Tests run on lab devices – cross labs and geos

Heterogeneous devices transmit data in CDX format

Institution X data

Institution, NGO users log into their servers and use aggregated regional EMR and logistical data

RemoteXpert receives data and securely stores it, generates machine health analysis and alerts

CDX client transmits formatted data from GX to institution servers

RemoteXpert GeneXpert

CDX

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 real-

time 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

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/

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

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.

WHO/ERS. Digital health for the End TB Strategy: an agenda for action. (WHO/HTM/TB/2015.21). Geneva, World Health Organization; 2015.

“Connected diagnostics” : a logical

first step in the development of TB

laboratory informatics

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