Summary of the context and overall objectives of the project

Prostate cancer is one condition where current diagnostic methods are limited. Men can request a blood test to measure levels of prostate-specific antigen (PSA). Whilst this is easy and relatively non- invasive, it has high levels of false positive and false negative results. Diagnosis to initiate treatment requires an invasive and expensive biopsy, which results in infections in 1.4% of cases. Around 20% of clinically significant cancers are missed by biopsy and 5-44% are over-diagnosed. Whilst they are cancer, they are unlikely to spread and shorten the life of the patient.

RNA analysis has the potential to transform cancer diagnosis. Compared to protein biomarkers, RNA biomarkers have higher sensitivity and specicity. However, to date, the inherent instability of RNA has limited biomarker development, because samples degrade before analysis when taken in hospitals, GP clinics or home settings. Furthermore, lack of specialised urine sampling devices creates huge sample variability, meaning clinicians cannot exploit the huge potential of urine analysis for urological cancer diagnosis. The potentially game-changing tool of RNA biomarker analysis has been confined to research labs because protocols to sample urine, then stabilise, purify and analyse RNA are very time consuming, costly and unsuitable for diagnostic settings.

Arcis Biotechnology Holdings have developed and patented PROSKit, a novel molecular diagnostic platform for the accurate diagnosis of prostate cancer based on urine analysis, based on Arcis’ chemistry to stabilise nucleic acids in urine for up to two weeks at room temperature and then allow their rapid analysis. The product can also allow sampling at home or Point of Care (PoC) using a patient-friendly sample collection technology, allowing preserving exquisitely unstable RNA biomarkers and analysis in specialized clinical environment through the PCA3 biomarker. In the Feasibility Study, we demonstrated we could stabilise RNA in urine. We also identified that differences in sampling made a huge difference to composition of urine and hence performance of our technology. Separate work has highlighted particular RNA sequences present in urine that indicate clinically-significant prostate cancer needing treatment.

The development steps to implement and validated PROSKit should target to demonstrate that we can detect clinically-relevant RNA sequences in urine. We have defined a way to safely package our chemicals within a device based on the Peezy by partner company Forte Medical, which will standardise sample taking. We have commenced a partnership with the University of Surrey, giving us access to a biobank of blood, urine and biopsy samples from prostate cancer patients and health volunteers. We will use this to correlate concentrations of RNA in urine with clinical prognosis for prostate cancer.

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 886322.