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Prostate MR Medical Imaging Biomarker Platform

Periodic Reporting for period 1 - QUIBIM qp-Prostate (Prostate MR Medical Imaging Biomarker Platform)

Reporting period: 2020-10-01 to 2021-09-30

Prostate Cancer (PCa) is the most common cancer in Europe and the second most common cancer worldwide for men with 1,276,106 new cases and causing 358,989 deaths in 2018. In Europe, PCa is the most common noncutaneous cancer, about 2.8 million men were alive who either once had PCa or who had it at that time. There are several tests to diagnose it with different levels of accuracy: blood-based prostate-specific antigen (PSA) tests, MRI scanning, and biopsy are the most common. They are, however, often inaccurate, inconclusive and most importantly fail to assess accurately the malignancy of the tumour, i.e. the risk of metastasis.

There is therefore a great need for new tools capable of predicting accurately the outcome of the disease to enable physicians to make the best clinical decisions for the benefit of patients, preventing both overtreatment and undertreatment. Quibim set out to transform prostate diagnosis and monitoring by developing a new non-invasive imaging tool using MRI data and advanced computer models to investigate the prostate anatomy in extreme detail. QP-Prostate, Quibim’s AI-based diagnosis solution, is an FDA(510k) cleared prostate MR images processing and quantitative analysis software package to be used by experienced clinicians.
To be able to bring QP-Prostate to the clinical practice, it must obtain first an FDA Clearance. With this project, we have been able to conclude the development of the automatic segmentation module and two analysis modules of QP-Prostate: Digital Reference Object Diffusion and Digital Reference Object Perfusion modules. With this project we have also been able to carry out a bench testing for the technical performance assessment of the tool, with very positive results. All of this has enabled Quibim to pursue and achieve a 510(k) FDA Clearance for QP-Prostate. The solution is being externally and clinically validated with installations at early adopters in the US, Spain, Poland, Slovakia, South America as safety and accurate decision support for PCa diagnosis, implementing our AI technology addressing PCa over- and underdiagnosis. In the attached image, it is shown the capture of QP-Prostate reporting system developed.
QP-Prostate is the only algorithm on the market that allows segmenting the prostate’s transitional zone, peripheral zone and seminal vesicles, helping clinicians to extract and analyze quantitative information from the whole organ. This groundbreaking solution will more efficiently provide information to aid in the diagnosis of prostate cancer, increasing diagnostic accuracy and, potentially, early prostate cancer detection, which may contribute to long term survival. QP-Prostate also enables physicians to save the extensive time devoted to make the reporting required by each diagnosis: descriptions of the tumours, attached evidence (MRI), prostate segmentation, which can take up to one hour of a costly specialist’s time.

Regarding healthcare impact, QP-Prostate enables physician to make better clinical decisions, preventing the risks, common in PCa, of overtreatment (exposing patients with indolent PCa to invasive biopsies and harsh treatments) and undertreatment because of an understatement of malignancy.

Regarding socio-economic impacts, QP-Prostate will enhance economic savings generated by more accurate diagnosis which lead to cost-efficient treatments, and also savings from costly tests such as biopsies (it requires an anesthesiologist, urologist, ultrasound guidance, pathology assessment, among others). The solution increases the specificity by the automatization in the detection of clinically significant PCa, allowing less experienced radiologists to be involved.
Capture of QP-Prostate reporting system