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Report

Teaser, summary, work performed and final results

Periodic Reporting for period 1 - ProstaPalp (Feasibility study to evaluate a novel prostate cancer diagnostic)

Teaser

Summary

Current screening for prostate cancer involves a prostate-specific antigen (PSA) test followed by a digital rectal examination (DRE) where a clinician feels for lumps on the prostate gland using their index finger. A high PSA result will typically lead to tissue samples (biopsies) of the prostate being taken for histological examination. 75% of patients who undergo a biopsy do NOT have cancer and yet they have been subjected to a costly and uncomfortable procedure.

Palpation Diagnostics has developed ProstaPalp, a novel device for diagnosing patients with prostate cancer and monitoring the progression of their disease over time. The device is fixed to the index finger of a clinician and is used during a standard DRE. Areas of the prostate are gently palpated with the device and the tissue response is measured. Based on data from early clinical studies it is expected that ProstaPalp will be able to distinguish between normal tissue, indolent cancer which does not require treatment and aggressive cancer which requires treatment. Patients that have indolent cancer will be put under surveillance and reassessed every three to six months. ProstaPalp will enable quantitative data to be collected from these patients so that the progression of their disease can be monitored.

The overall objectives of the project were to:

1) Validate the clinical need and confirm where in the patient treatment pathway the ProstaPalp device will be used in different key markets. This will be done through existing links through the European Association of Academic Urologists and the American Urological Associations to engage key opinion leaders in the EU and US markets.

2) Quantify the key markets (in Europe, USA and Far East) and potential treatment costs to validate the business case.

3) Identify the health economic benefits of the technology and treatment.

4) Confirm the regulatory pathway and the scale of clinical trials required for a commercial product.

5) Detail the product development costs and timescales and ultimate manufacturing costs.

6) Confirm the best initial route to market.

7) Incorporate the information gathered into a robust and appealing business plan.

All of the objectives set out in the Phase 1 project proposal have been successfully addressed and the results from the project have been extremely valuable in helping develop a robust H2020 SME Instrument phase II application, which will be submitted in early 2017.

Work performed

Objectives 1 (validate the clinical need) and 2 (quantify the key markets) were successfully achieved through independent market research with key opinion leaders in the UK, Germany and USA. The consultant urologists confirmed the need for a better diagnostic tool for prostate cancer and confirmed the large markets worldwide.

Objective 3 (identify health economic benefits): A high level independent health economic assessment confirmed potential health care savings in the UK if the ProstaPalp technology is used in prostate cancer screening whilst also providing a good profit margin for the Company.

Objectives 4 (confirm the regulatory pathway) and 6 (confirm best initial route to market): Two regulatory consultancies have recommended the same development strategy for ProstaPalp products to enable a first product to be marketed in Europe at the earliest opportunity. This first product could be tested within the currently approved and funded clinical study. The regulatory route for the USA, the largest single market, is expected to be via a de novo 510k application.

Objective 5 (detail product development costs): Two design consultancies have provided budgetary estimates and timescales for the detailed design and manufacturing scale up of the ProstaPalp products.

Objective 7 (create business plan): The information gathered as part of the Phase 1 project has been incorporated into an updated business presentation and has already resulted in an award to support the management in attracting further investment and grants.

Final results

The ProstaPalp test could radically improve the diagnostic pathway for prostate cancer. The ProstaPalp test complements existing blood tests and imaging interventions for prostate cancer diagnosis, and can give an accurate measurement of prostate stiffness. Prostate stiffness is a biomarker for prostate cancer, and initial data shows that ProstaPalp is sensitive enough to distinguish between different types of cancer based on stiffness.

The ProstaPalp test could act as an effective triage tool for prostate cancer, allowing urologists to more accurately decide whether a patient needs a biopsy. This could reduce the high incidence of negative biopsies, providing a cost saving to health care providers, saving time for healthcare professionals, and reducing the pain and discomfort for the patient associated with prostate diagnosis.

The H2020 SME Phase I funding has confirmed the market need for ProstaPalp, allowed economic modelling to show its benefits to society, and allowed appropriate regulatory pathways and product design tasks to be identified. The funding has been instrumental in starting to move ProstaPalp from a prototype device to a commercially-viable business proposition for sale in the global prostate cancer diagnostic and screening market.