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Diagnostic App Development

How Does Novarum Work?

Every Novarum project starts with our team gaining a deep understanding your assay/product,  the target end user for your test and how a mobile solution helps differentiate your product’s value proposition.   

We start with our patented Novarum technology to build a reader module for your mobile application suitable for your assay format, whether that is a naked strip or a housed cassette. 

Our team then works with you to map out the three main stages of your end user’s journey to identify the features and functionality that is needed to address the end user’s needs and to minimise the risk of end user error.  Some examples that are considered are shown below. 

Pre-scan workflow 

  • Login/User ID 
  • Different user types could have different workflows 
  • Change app language to match that of the phone 
  • Check the camera is working 
  • Record location of the phone 

In-scan workflow 

  • Select test type from menu or scan barcode which selects the correct test type 
  • Video or graphic instructions  to guide user through running assay 
  • Automatic batch check for expiry date etc 
  • Record patient ID or sample ID 
  • Provide and enforce countdown timers to ensure assay is read at correct time 
  • Read test and apply threshold to bin or quantify result

Post-scan workflow 

  • How is the result managed? 
  • Result is sent to central database (manufacturer/health service/other) or shared with an EHR/LIMS 
  •  Result is only stored on phone locally 
  • How  the result is displayed to the user 

A range of different functionalities can be implemented to support the user through the workflow of setting, running and then sharing the assay results. 

The table below summaries some of these additional features: 

Stage 

Features 

Description 

Pre-scan Workflow 

GPS Tracking 

Trace outbreaks and epidemics in real-time. 

In-scan workflow 

Batch Calibration 

Every batch can be calibrated to manage production variability, decreasing the frequency of false positives and negatives, increasing reliability, building trust in your test in the marketplace and improving patient outcomes. 

In-scan workflow 

Signature Pad 

On-screen signature pad to capture end user consent. 

In-scan workflow 

Questionnaire 

Collecting patient meta data through a questionnaire to supplement diagnostic results. 

In-scan workflow 

Multiple Assay Reading 

Ability to read a portfolio of assays or multiplexed tests in one app, reducing development cost and providing a consistent user experience. 

In-scan workflow 

 Multiples Assay User Test Selection

Simplify your multiplex test product range by having one app for all and selecting the test features required for your application. 

Post -scan workflow 

Data Security 

Data encryption, user management and limit log-in  access to authorised users, supporting GDPR compliance as well as increasing confidence in data confidentiality. 

Post -scan workflow 

Systems Integration 

Integration with Lab Information Management Systems, electronic health records and automatically report results to regulators, whether for infectious disease or performance animal compliance. 

Post -scan workflow 

Remote Result Sharing 

Even in the most remote locations results can be shared with the right person immediately, using email, Wi-Fi, SMS, web, 3G, Bluetooth or USB. Instant results when it matters most, ensuring efficient action and treatment. 

Regulatory support 

We provide support and aftercare to ensure your software remains up-to-date and running smoothly:  

  • Our experienced team provide full regulatory support in submissions for CE marking and FDA clearance  
  • We have successfully achieved CE marking and FDA pre-submission of IVD systems that include Novarum mobile medical apps and web portals  
  • We provide full design history files of your product for submission purposes, electronically managed in our JIRA system  
  • We are ISO13485:2016 compliant and we conform to IEC62304  
  • 100% client audit record and proud to always be in the ‘audit ready’ status  

Please contact our Customer Services Team directly to discuss your requirements on tel:+44 (0) 1495 363000 or alternatively you can submit an enquiry here.


  1. Novarum has been awarded the patent (EP 12718728.4) for its smartphone diagnostic technology by the European Patent Office (EPO), having already secured the equivalent patent for its technology in the United States  

  1. Novarum™ worked with BÜHLMANN Laboratories AG to create the first CE-Marked smartphone-based calprotectin home test –IBDoc®, the first in vitro diagnostic testing device measuring the inflammatory marker for faecal calprotectin at home.  

 

 

 

 

 

Technical Documents

Last updated: 26/03/2021

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BBI Solutions Brands

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The acquisition of DIARECT in June 2020 and their world leading recombinant autoimmune antigen capability immediately enhances BBI’s portfolio and position as a ‘complete’ immunoassay reagent supplier. This further enhances BBI’s position as the world’s largest diagnostics components company with a market leading antigen portfolio.

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Maine Biotechnology Services brings 27 years of knowledge, experience, process development, and project management to our customers to ensure the best possible antibodies for any application. As antibody development goals in the biotechnology and pharmaceutical industry have evolved the acquisition of MBS will help BBI further meet and exceed our customers needs.

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