Commercialisation of novel image processing and display software for breast screening

Lead Research Organisation: Institute of Cancer Research
Department Name: Division of Cancer Therapeutics

Abstract

This project aims to translate cutting-edge research software for detecting breast tumours on
MRI scans into a commercial product.
Previous Institute of Cancer Research (ICR) development was supported by EPSRC and the
current, fully functional, prototype software incorporates a number of novel and patented
features.
Biotronics3D creates high quality software for healthcare professionals. It wishes to
incorporate the ICR prototype into 3DnetMedical, its flagship product. 3DnetMedical provides
a state-of-the-art integrated radiology platform, with all the image visualisation features and
integrated workflow demanded by clinicians. These features are currently missing from the
ICR software and ICR is unable to provide them.

Planned Impact

We wish to repeat this same successful model for the current project. MRIW has a sister
product, MARIBSview, which is specifically targeted at DCE-MRI of the breast. Whilst MRIW
is a tool for detailed modelling during the assessment of previously diagnosed cancers,
MARIBSview is aimed at the rapid processing of data for patient screening. It was initially
developed to analyse data from the Magnetic Resonance Imaging Breast Screening
(MARIBS) 22-centre UK trial. The results of this significant trial have been widely commented
on in the scientific literature, with more than 260 citations of the key Lancet publication [3].
Novel algorithms created during the initial development of the associated software have led
to three families of patents (details below). We now wish to commercialise this intellectual
property (IP) in conjunction with Biotronics3D, together with other novel software that has
been created in the context of EPSRC grant EP/E035736/1 and the CRUK-EPSRC joint
grant C1060/A10334. This novel technology will introduce significant new visualisation tools,
such as “dual-phase volume rendering” and motion detection, which are not available in rival
products, together with methods for estimating the MRI breast “density” (i.e., the ratio of fatty
to non-fatty tissue). This MRI measure has been shown [4] to correlate with x-ray
mammographic density, which is linked to risk of developing breast cancer.
The new product would form the DCE-MRI breast-screening element (tentatively scheduled
for release under the product name “MRI CAD”) of 3DnetMedical [2], a family of advanced
processing applications. Biotronics3D is pioneering a new “zero-footprint”, cloud-computing
approach to medical image analysis software, which significantly reduces the financial hurdle
for clinics wishing to acquire these advanced capabilities. The suite was premiered at the
2010 Radiological Society of North America (RSNA) annual meeting, which attracts anaround 50,000 participants (news report at http://goo.gl/WKXhb).
Given the already highly-developed nature of the product, the “timeframe to impact” of the
new breast-screening element of the package should be less than 12 months from the end of
the project. Evidence in support of this assessment comes from the considerable interest
that has already been shown in 3DnetMedical since its launch in late November 2010,
although it is still too early to have any quantitative data on sales figures.
Aims and objectives
The top-level objective of the project is straightforward: the commercialisation of a defined
set of pre-existing MRI analysis software. This entails the following steps:
1. Update of market analysis for MRI breast screening software
Delivery Month 3 of project
a. Documentation of features of competing products and analysis of the commercial
advantages of the new product
A detailed market report [5] was prepared for the ICR in November 2006. This
analysed the features of all competitive software in the area of DCE-MRI. Prior to the
development and launch of the new product, this report needs to be updated to take
account of the latest developments by competitors.b. Compilation of a list of potential customers
c. Development of detailed business plan and marketing strategy
Element a will be undertaken by placing a subcontract with a market research
organisation such as UK Bioscience Consultants Ltd., whilst we envisage b and c
being done by Biotronics3D with significant input from both the market research
organisation and the mentoring service provided by this project.
2. Development of modified software
Delivery Month 12 of project, but with major milestone December 2011 (Month 8) for
demonstration at RSNA 2011 conference
a. Re-implement ICR codebase in C++ / Microsoft Silverlight.
From the outset, the ICR team sought to design MARIBSview as software that could
be commercialised. It has been written rigorously, to a high technistandard. The
original code was developed in a language IDL that is highly appropriate for rapid
prototyping in an experimental system, but less suitable for enterprise-level
applications. The re-engineering that we propose here parallels that performed
already for MRIW, and so ICR and Biotronics3D have both a good understanding of
the technical hurdles and a proven ability to meet the relevant milestones.
(9 months)
b. Integration of data I/O with Biotronics3D standard methods. (1 month)
c. Replacement of existing viewer with Biotronics3D “zero-footprint” web interface.
(1 month)
d. Development of dedicated display protocols (often called “hanging protocols”) for
wider radiologist acceptance (1 month).
e. Creation of technical folder to be used for market clearance
Steps a-e will be undertaken by a programmer with appropriate experience of both
DCE-MRI and C++ / Microsoft Silverlight. The individual will be employed by ICR, but
work a significant fraction of the time at Biotronics3D.
References
[1] http://www.javelin-ventures.com/index.asp?pgid=9
[2] http://www.3Dnetmedical.com
[3] Leach MO et al. Lancet. 2005 May 21-27;365(9473):1769-78
[4] Thompson DJ et al. Breast Cancer Research 2009, 11:R80 (doi:10.1186/bcr2447)
[5] Cox, VF 2006 Market Report on Computer Aided Detection and Diagnosis Technologies
relating to ICR Breast MR/CAD portfolio, UK Bioscience Consultants Ltd, unpublished report
commissioned by ICR
 
Description 1. Specifications for the new MARIBSview software product were jointly agreed by the ICR and Biotronics3D and are set

out in the document "MARIBSview software/3Dnet Integration Plan and Functionality.

2. A new member of staff, Paul Martin, was recruited. Paul translated the existing in-house code for the processing of MRI

breast image data from the original IDL prototyping language into C++. The code is now self-contained and can be used as

a toolkit. Thus, it can be incorporated into a wide range of different applications that require this type of processing.

3. Biotronics3D provided programming support through one of its staff members, Rado Andriantsimiavona, who developed

a user interface (making use of the toolkit developed in item 2) within the Biotronics 3Dnet web framework. By the end of

the project, this web application had reached the "working prototype" stage and required little further work before

demonstration to a clinical audience. Potential candidates for a Clinical Advisory Board were identified and Biotronics3D

should be in a position to take this forward with ongoing support from the ICR.

4. A full market analysis was completed in the area of the development. The company Evolution Biosciences was retained

to perform this task and reported on time in February 2012. Evolution produced a comprehensive document that included

the results of a structured telephone survey designed in conjunction with ICR and Biotronics3D. In total, 116 stakeholders

were contacted.

A number of subsidiary items remain to be achieved by the company at the end of the project. These include gaining

regulatory approval for the new product and creating a detailed business plan and marketing strategy.

Part of this project involved a mentoring service and the facilitation of meetings. This was excellent and contributed greatly

to the successful completion of the project.
Exploitation Route this includes diagnosis and management of breast cancer, identification of target locations for functionally directed biopsy and treatment of breast cancer. The software developed provides a variety of tools to evaluate breast disease. Many of these have been piloted and demonstrated previously in research applications.

A tool to support research into breast density and association with disease, into improved diagnosis of breast cancer, into determining extent of disease to plan therapy, into assessing suitability of certain treatments, and monitoring the effect of treatment, in evaluating novel treatments.

The software can support a range of routine assessments of breast cancer using MRI, supporting the clinical management of breast disease. It forms a larger component of a commercial diagnostic software platform produced and marketed by Biotronics3D.

We have also integrated aspects of the software into a commercial product that is currently in prototype form to detect, characterise, guide targeted biopsy and cryosurgery of breast cancer with Specialty Magnetics Ltd.
Sectors Healthcare

 
Description A set of software routines that provide a range of breast cancer analysis functions have been written to GMP. These have been made available to the commercial collaborator who is installing them in a cloud interface. They are also available to us and we will provide a separate non-cloud based interface to facilitate direct use on non-anonymised clinical research images
First Year Of Impact 2014
Sector Healthcare
 
Description NIHR TRF
Amount £198,520 (GBP)
Funding ID TRF-2013-06-003 
Organisation National Institute for Health Research 
Sector Public
Country United Kingdom
Start 11/2013 
End 10/2015
 
Description Collaboration with Biotronics3D 
Organisation Biotronics3D
Country United Kingdom 
Sector Private 
PI Contribution Collaboration to exploit academic software. The colloboration includes providing a commercial platform for academic software, a CASE student and shared software development.
Collaborator Contribution Provided a commercial framework in which to embed our new software developments. Marketed this framework.
Impact Software for image analysis engineered to GMP levels
Start Year 2009
 
Description breast density assessment and risk 
Organisation London School of Hygiene and Tropical Medicine (LSHTM)
Country United Kingdom 
Sector Academic/University 
PI Contribution Development of analysis techniques for assessing MRI breast images. Application to a range of data from a large study hosted at LSHTM
Collaborator Contribution Making available a large image data base (partly built on earlier collaborations with me) Developing additional image processing approaches
Impact Several papers published or in course of publication Epidemiology, physics, informatics, public health
Start Year 2012
 
Description breast density assessment and risk 
Organisation University College London
Country United Kingdom 
Sector Academic/University 
PI Contribution Development of analysis techniques for assessing MRI breast images. Application to a range of data from a large study hosted at LSHTM
Collaborator Contribution Making available a large image data base (partly built on earlier collaborations with me) Developing additional image processing approaches
Impact Several papers published or in course of publication Epidemiology, physics, informatics, public health
Start Year 2012
 
Title Prototype GUI to connect MARIBSview to Biotronics3D product 
Description A prototype GUI that interfaces the software modules prepared in this project, to the manufacture's cloud based software, has been developed and demonstrated by the manufacturer. 
Type Of Technology Physical Model/Kit 
Year Produced 2013 
Impact Available as part of a portfolio of cloud based products 
 
Title Prototype MARIBSview software 
Description A set of modules written to commercial software standards suitable for FDA approval providing the main functionality of the research version of MARIBSview. These have been demonstrated and shown to work. THey are now being integrated into the commercial cloud based product by Biotronics3D 
Type Of Technology Physical Model/Kit 
Impact Supports a range of research including commercial trials 
 
Description Demonstration of software with prototype scanner 
Form Of Engagement Activity A talk or presentation
Part Of Official Scheme? No
Geographic Reach Regional
Primary Audience Professional Practitioners
Results and Impact The software has been used to demonstrate the capabilities of a prototype MRI guided breast biopsy and cryosurgery system

Positive project report from TSB
Year(s) Of Engagement Activity 2013