Periodic Reporting for period 1 - PROSKit (Prostate cancer urinary diagnostic kit based on RNA biomarkers)
Período documentado: 2020-01-01 hasta 2020-06-30
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.
The feasibility study allowed to validate the feasibility of the technology by confirming the capacity of Arcis extraction process to isolate and stabilize free mRNA from fresh urine samples, with the inclusion of a proprietary homogenisation step. These results show compliance of the ARCIS rapid RNA and DNA extraction process from urine with long term stability of mRNA at 4°C and room temperature. Results of this work prompts to envisage a new standard for clinical diagnostic in urine samples. Arcis intends for its technology to be used by the public, at home, and need no specialist sample storage. Moreover, PROSKit will offer around 28% more accuracy in test results in comparison to existing PSA solution and a cost reduced of around 85% respect to biopsy. The PROSKit layout and procedure were defined, including the chemical mix features. Cost and price for the solution were also delineated, identifying the break-even point in terms of production and potential gross margin achievable. The plan of activities to finalize the product, validate it clinically and bring it to the market were defined, also identifying the partners required for collaboration. The Addressable Markets PROSKit as substitution of prostate cancer screening were quantified. The Business Model and the go-to-market strategy were outlined and the Business Plan for product development and 5 years sales was defined.
PROSKit is able to reduce the number of false positive from the PSA test and so the number of unnecessary biopsies. The other competitors existing solutions require laboratory analyses, complex procedures and specific tools. PROSKit instead offers i) Rapid- samples ready for analysis in <3 minutes, results in <2 hours if tested at surgery, compared to days for biopsy, ii) Time preservative- intact amplifiable RNA biomarkers already validated after 7 days; iii) Accurate- greater sensitivity and specificity than current PSA blood test: PCA3 presents a 28% higher discriminative capability than PSA; iv) Inexpensive- as informative as multi-core biopsy for <10% of the price; v) High throughput- PROSKit samples can be collected anywhere, non-invasively and thousands analysed simultaneously at a central location. PROSKit will have beneficial impact for the National Healthcare systems, by enhancing earlier diagnosis of prostate cancers and reducing expensive treatments. Performing 450,000 PROSKit tests in 2026 and assuming our technology identifies PCa at a better rate than PSA testing, we will identify 1290 cases earlier than otherwise, reducing the treatemtn cost potentially of > € 5,000/patient, reducing the number of required biopsies, hospitalizations and treatments for later stage interventions. We expect our technology to prove more effective than the optimum implementation of PSA testing; thus, carrying out 450,000 tests has the potential to save over 81,000 life years.