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Detecting, analysing and interpreting diagnostic
devices for use outside clinical laboratories
 Most value provided to diagnostic tests taken in remote
locations (in-field) or at the point of patient care (at home)
 Support patient care within chronic/autoimmune disease
monitoring, or to diagnose and track infectious disease
 Can be applied to almost any visually read tests including:
lateral flow, colorimetric, ELISA and agglutination
 CE-Marked medical products for IBD in Europe & Canada.
First FDA 510 (K) approval in the US expected Dec 2018
 Patent protected in the US, Europe (includes UK), China,
Japan, Russia.
 Use cases in human clinical, animal health, food safety and
environmental
 ISO 13485:2016 and EIC 62304 compliant
About Novarum DX
Read and share the results of point of care tests using
smartphone reader technology.
 Healthcare institutions overburdened
 Waiting lists - increasing time to result
 Geographic barriers to healthcare provision
 Resource poor settings and infrastructure
 Inconvenience of recurring appointments
 Patients too sick to travel
Decentralised Healthcare
Mobile Ecosystem
Multi-frame analysis
technique provides highly
accurate results, whilst
removing human subjectivity.
Test results shared securely
to an end-user portal online.
Image-capture technology transforms a mobile phone into a diagnostic test reader
the results of which are shared to an end-user portal.
 Step-by-step instruction carousels
 In-app Videos and voice instruction
 Incubation timers and alarms
Correct sample preparation is achieved using
Test Choreography which ensures incubation
periods are adhered to - preventing false results.
How can errors be prevented?
 Patients can monitor chronic conditions with regular self-testing
 Bedside testing an option for patients who are too sick to visit their GP
 Overcomes geographic constraints for patients too remote from healthcare provision
 Maintains confidentiality and removes the stigma of attending sexual health clinics
 Enables lay users to have confidence in performing tests
 Enables clinicians to trust self-tests
Point of Care Testing – At Home
Crohn’s Disease & Ulcerative Colitis
The first CE-Marked smartphone-
based calprotectin home test
measuring the inflammatory marker for
faecal calprotectin at home.
 Mobile App (CalApp®)
 Desktop Portal (IBDoc®)
Data recorded from the portal is shared
with trusted end-users, which can
include Electronic Healthcare providers
to shape the future of healthcare.
SOURCE: BÜHLMANN Laboratories AG
 Help to reduce the spread of blood-borne disease with an early diagnosis
 Support technician fieldwork with quick and accurate test results outside a laboratory
 Tag test results with a geo-location to track infectious disease outbreaks
 Enable connected, monitored testing in remote locations
Point of Care Testing – In Field
 Rapid diagnosis to distinguish between bacterial and viral infectious
 Robust traceability for prescriptions to human and food-producing animals
 Track and trace infectious disease outbreaks to limit its spread
Antibiotic Stewardship
Overestimate the expectations of patients to get a prescription
 Patients want to feel better
 Patients don’t want to wait for an appointment if they don’t improve
 Patients find it easier to accept if there is a test result
Prof Klepser @ Ferris State University – extensive research on the role of Community Pharmacists in reducing antibiotic overprescribing
Potential for Pharmacists?
 Unlikely to happen without a government driven agenda
 Requires a joined up ecosystem to manage diagnosis, prescription,
care and follow up of antibiotic use
 Putting patients at centre could transform the approach – and mobile
may enable that
Viability?
T: +44(0)131 290 2 290
npolwart@novarumdx.com
enquiries@novarumdx.com
www.novarumdx.com
LT-41_2018_10_22

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Detecting, analysing and interpreting diagnostic devices

  • 1. Detecting, analysing and interpreting diagnostic devices for use outside clinical laboratories
  • 2.  Most value provided to diagnostic tests taken in remote locations (in-field) or at the point of patient care (at home)  Support patient care within chronic/autoimmune disease monitoring, or to diagnose and track infectious disease  Can be applied to almost any visually read tests including: lateral flow, colorimetric, ELISA and agglutination  CE-Marked medical products for IBD in Europe & Canada. First FDA 510 (K) approval in the US expected Dec 2018  Patent protected in the US, Europe (includes UK), China, Japan, Russia.  Use cases in human clinical, animal health, food safety and environmental  ISO 13485:2016 and EIC 62304 compliant About Novarum DX Read and share the results of point of care tests using smartphone reader technology.
  • 3.  Healthcare institutions overburdened  Waiting lists - increasing time to result  Geographic barriers to healthcare provision  Resource poor settings and infrastructure  Inconvenience of recurring appointments  Patients too sick to travel Decentralised Healthcare
  • 4. Mobile Ecosystem Multi-frame analysis technique provides highly accurate results, whilst removing human subjectivity. Test results shared securely to an end-user portal online. Image-capture technology transforms a mobile phone into a diagnostic test reader the results of which are shared to an end-user portal.
  • 5.  Step-by-step instruction carousels  In-app Videos and voice instruction  Incubation timers and alarms Correct sample preparation is achieved using Test Choreography which ensures incubation periods are adhered to - preventing false results. How can errors be prevented?
  • 6.  Patients can monitor chronic conditions with regular self-testing  Bedside testing an option for patients who are too sick to visit their GP  Overcomes geographic constraints for patients too remote from healthcare provision  Maintains confidentiality and removes the stigma of attending sexual health clinics  Enables lay users to have confidence in performing tests  Enables clinicians to trust self-tests Point of Care Testing – At Home
  • 7. Crohn’s Disease & Ulcerative Colitis The first CE-Marked smartphone- based calprotectin home test measuring the inflammatory marker for faecal calprotectin at home.  Mobile App (CalApp®)  Desktop Portal (IBDoc®) Data recorded from the portal is shared with trusted end-users, which can include Electronic Healthcare providers to shape the future of healthcare. SOURCE: BÜHLMANN Laboratories AG
  • 8.  Help to reduce the spread of blood-borne disease with an early diagnosis  Support technician fieldwork with quick and accurate test results outside a laboratory  Tag test results with a geo-location to track infectious disease outbreaks  Enable connected, monitored testing in remote locations Point of Care Testing – In Field
  • 9.  Rapid diagnosis to distinguish between bacterial and viral infectious  Robust traceability for prescriptions to human and food-producing animals  Track and trace infectious disease outbreaks to limit its spread Antibiotic Stewardship
  • 10. Overestimate the expectations of patients to get a prescription  Patients want to feel better  Patients don’t want to wait for an appointment if they don’t improve  Patients find it easier to accept if there is a test result Prof Klepser @ Ferris State University – extensive research on the role of Community Pharmacists in reducing antibiotic overprescribing Potential for Pharmacists?
  • 11.  Unlikely to happen without a government driven agenda  Requires a joined up ecosystem to manage diagnosis, prescription, care and follow up of antibiotic use  Putting patients at centre could transform the approach – and mobile may enable that Viability?
  • 12. T: +44(0)131 290 2 290 npolwart@novarumdx.com enquiries@novarumdx.com www.novarumdx.com LT-41_2018_10_22