The imprecision of PSA-biopsy has spawned a large, competitive, marketplace in which companies add value by mitigating diagnostic imprecision. Some focus on pre-biopsy, whilst others try to correct the imprecision of the biopsy score. Another group of companies are trying to derive additional information from MRI derivatives to enhance diagnostic precision.
The commercial partners of ReIMAGINE will contribute to an overall model of disease progression. There have been few combined studies of commercially available biomarkers to assess their relative incremental benefit. ReIMAGINE is the first attempt to do this at scale.
A problem encountered when performing an MRI scan of the prostate is variability in the way images are acquired. This is a bigger problem in clinical trials where standardisation (or at least understanding variability) is essential when comparing between different patients. Affidea is the largest provider of diagnostic imaging services in Europe with the most advanced MRI standardisation and optimisation program running across 12 countries using proprietary analytics and processes. Affidea is providing both the analytics tool and process optimisation to allow real-time data analysis of scans being performed during the trial to ensure that they are all being undertaken in a reproducible and valid manner.
Maxwell Plus is an Australian med-tech company using AI for personalised screening and improved diagnosis of prostate, lung and breast cancer and neurodegenerative disease. In the ReIMAGINE project, the Maxwell Plus platform will perform specific analysis of patients’ MRI images, using cutting edge AI to assist with the detection, diagnosis, and reporting of prostate cancer. Applying Maxwell Plus models to the best-characterised prostate cancer cohorts will assist in validation of the models and help quantify the potential of AI within prostate cancer diagnosis.
IAG is delighted to contribute its imaging and machine learning expertise to the project. IAG are experts in MRI used for clinical research and in the advanced analysis of MRI images to assess disease and show progress of patients over time. The advanced image processing and machine learning techniques developed at IAG will be used to analyse data collected.
ProteoMediX is specialised in developing truly disruptive blood-based tests for the improved diagnosis and management of prostate cancer. ReIMAGINE presents a unique opportunity to permit a re-calibration of ProteoMediX’ tests to be used in the MRI-based imaging era. The collaboration allows for the development of a test-model that can determine a patient’s individual risk for developing prostate cancer.
MIM Software will be used in the project as the platform for segmenting visible lesions using mpMRI and for capturing and analyzing quantitative image processing data. MIM is a pathway solution for managing prostate cancer with imaging and provides image guidance from initial mpMRI reporting to fusion biopsies. The software also supports fusion-guided treatment or reimaging and analysis for active surveillance.
Minomic has developed an in vitro diagnostic blood test called the MiCheck® test for the detection of prostate cancer that also better differentiates aggressive from non-aggressive cancers. As the test has a higher specificity than tests like PSA it is able to reduce the number of men proceeding to biopsy. Minomic is preparing to launch the MiCheck® test in the US this year.
Exosome Diagnostics will apply their unique and proprietary technology for extraction of exosomes and microvesicles from patient urine. The lipid bilayer surrounding exosomes and microvesicles offers a unique protection to the various analytes inside (RNA, DNA, protein) from an otherwise harsh environment of a biofluid. Unprotected molecules in biofluids will quickly be degraded by enzymes such as proteases and RNases, but when encapsulated within exosomes they are stable for extended periods of time. Exosome Diagnostics will analyse the samples collected during ReIMAGINE with its existing ExoDx Prostate (IntelliScore) test as well as develop alternative biomarkers for use in conjunction with mpMRI.
Chronix Biomedical, Inc. is a privately held biotech Company for more than 20 years that specializes in molecular diagnostics. By measuring cell-free DNA in the blood, the innovative technology allows early assessment and follow-up of the chances of success of cancer treatments. The Company also provides DNA testing to determine in real time whether the body is rejecting a transplant organ. Chronix Biomedical is a recognized leader and the only Company that covers both these major medical fields.
As part of the ReIMAGINE program, Philips Research will build the IT infrastructure for integration of heterogeneous patient data (demographics, clinical data, and radiology and laboratory data, including data from clinical chemistry, histopathology and genomics). This task will focus on establishing an infrastructure that is suitable for advanced analytics, which comprises making sure the right data are collected and getting the data in good shape for analysis by ensuring excellent quality, completeness and consistency. Finally, predictive algorithms will be developed by integrating the data collected across the different categories, leveraging Artificial Intelligence and other advanced analytical methods.
MDxHealth will perform specific analysis of patient’s samples using proprietary multiplexed blood, urine, tissue, and epigenetic based tests.