News

Progress during the first year of the H2020 grant-funded project, LAUREN, June 2016

Summary of the context and overall objectives of the project

Bladder cancer is a common cancer, with over 429,000 new cases diagnosed globally in 2012, and it is an expensive cancer, costing the UK alone over £50 million per year. Currently, the gold standard diagnosis and management tool for bladder cancer is cystoscopy, which is expensive, uncomfortable and carries a risk of infection. Because of the high recurrence rate of bladder cancer (up to 35% in the first 3 years), these shortcomings are exacerbated by the need for repeated surveillance, which may extend to quarterly cystoscopies for 1-2 years post-surgery, every 6 months in year 3-4, and annually thereafter.

By transforming urine cytology, a complementary adjunct to cystoscopy, Cytosystems is developing technology to reduce the number of cystoscopies required for bladder cancer patients. The monoclonal antibody at the core of Cytosystems' assay is specific for minichromosome maintenance protein-2 (MCM2), licensed by Cancer Research Technology. Enabling technologies have been developed to create an integrated bladder cancer risk stratification package BladderLightTM. The three components of BladderLightTM  are as follows, which correlate as the three aims of the project:

•        A low-cost, single-use cell collection device which both preserves cells and optimises the quality of cell capture

•        Patented MCM2 biomarker technology stain

•        Digital imaging and diagnostic algorithms. The automated analysis highlights cancer cells for clinical viewing.

The first objective of the project is to design, evaluate, and manufacture pre-prototype devices, in conjunction with a specialist medical device design company. These devices will be subject to full clinical evaluation for regulatory purposes. Our results to date have been equivalent to the cell capture of centrifugation – the laboratory ‘gold’ standard. The final prototype will then be subject to a larger trial in 2017 as part of the full BladderLightTM package.

The second project objective is to define the procedure of slide preparation and staining. Several optimisation experiments have been informed in-house and renowned consultant cytopathologists have advised. Such slide preparation has paved the way for developing the automated analysis.

The third objective of the project is to analyse the images of the stained slides which has been done in collaboration with a university. The analysis concerns staining of cells with our patented proliferative biomarker MCM2, and also concerns morphometric features. The first set of results are very encouraging, proving our algorithms to have the potential to be very robust.

Underpinning the objectives of the project is the regulatory path. Before market placement and an extensive programme of clinical evaluation, Cytosystems is aiming for CE-marking and FDA approval.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Our first activity concerned the concept and planning of the project.  We prepared a formal plan documented to ISO13485 (the international standard for medical devices) including planning of risk assessment and management throughout the project and validation planning - how the various stages will be validated to regulatory standards.  We considered the feasibity within timescales, budgets and resources.

We reviewed our proposed cell collection method with initial focus on the method of cell capture, we were  able to do this before we formally employed a sub-contractor who added mechanical design, ergonomics and manufacturability experience.   Design concepts were produced and considered with manufacturing strategies.  Some design concepts progressed to prototype models tested in our laboratory using urine samples, some spiked with EJ28 cancer cells but later, after ethics approval and contractual arrangements, we used urine from bladder cancer patients.  We compared our cell collection method with the established technique of cell centrifugation, our results confirming that our methods are at least equivalent to or superior to centrifugation.  

We also achieved a far greater understanding than we had expected concerning cell behaviour and the challenges of separation whilst minimising the risk of cell damage, whilst this has taken longer than expected, our greater understanding allows us to secure intellectual property by patent.

We defined the procedure of slide preparation and staining, a precursor to the objective to analyse images of the slides stained with our proliferative biomarker MCM2 including morphometric features.  We investigated available image processing and analysis software and have started initial discussions with a software house for commercial application.   The ethics approval and contractual arrangements for urine samples from bladder cancer patients has led us to a good supply of material for proving our procedures. 

In parallel with the scientific and laboratory work we developed the documentation structure for ultimate regulatory approval both for Europe (CE-marking) and the USA (Food and Drug Adminstration – FDA).  We are now getting guidance from the FDA for the appropriate regulatory route and details of addition information that the FDA requires. 

We made progress with exploitation and dissemination (including commercialisation).  We carried out a martket evaluation and developed an  exploitation strategy.  We are now in contact with possible collaborating companies, to engage with markets such as Germany, France, Italy, Spain, UK – in Europe – and the USA, China, Japan and India in the rest of the world.  We also supported our commercialisation aims, for example,  – a new website with news items and press releases, product brochure, attendance at the MEDICA trade show and collaborating with a company video.  

We appointed a regulatory affairs specialist at the start of the reporting period and our Quality Assurance procedures are being developed as the project progresses.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Our work on the cell collection device highglighted some unexpected issues concerned with cell handling but has led to progress beyond the state of the art.  Our work led to some novel ideas and the first patent application from the project.  Our second patent application concerns the monoclonal antibodies which we use and a third patent concerning image analysis is in preparation.

Based on the project’s progress we believe that our methods and products will lead to a significant improvement in the management of patients with bladder cancer and eventually helping to diagnose bladder cancer before treatment.  Details of the socio-economic impact will be forthcoming after we carry out a health economics study but already it is clear that our methods and products should be more economic thus saving direct and indirect healthcare costs and reduce the number of uncomfortable procedures for patients.

Horizon Grant Funding Video

Chief Executive, Richard Berry, and Director of Product Management, Nigel McLean, talk about the Horizon Grant award.

Cytosystems Secures Horizon Grant of €3.2 million

Grant Will Be Used to Accelerate Commercialisation of Bladder Cancer Diagnostic

Aberdeen, 4 May 2016 … Cytosystems, a clinical stage diagnostic company, developing new diagnostics for bladder and prostate cancer, has been awarded a grant of €3.2 million, through the EU Horizon 2020 Scheme, one of the largest grants to be awarded to the life sciences sector of the UK, and the largest for Scotland.

Cytosystems has developed a range of technologies which can be used to improve the diagnosis and management of bladder cancer. The grant will be used to validate specific biomarkers, found in urine, which can be used to accurately detect the presence of cancer.

The grant will allow Cytosystems to fast track development of a non-invasive in-vitro diagnostic, providing end users and purchasing decision makers with the tests accuracy and health economic benefit through completion of a multi-centre clinical trial. 

Cytosystems has developed a novel technology for urine cytology called BladderLight™, which will be clinically validated through this grant. BladderLight™ is a novel diagnostic technology that enables a diagnosis with improved accuracy that is non-invasive. This technology provides physicians with the tools for collecting and processing the patients’ urine, testing the urine for the presence of cancer cells, rather than the traditional method of cystoscopy, an uncomfortable and invasive test.

Not only will BladderLightTM aid the initial diagnosis of bladder cancer, the test will also relieve some of the burden of the management of bladder cancer post-treatment. Bladder cancer patients, due to the high recurrence of the disease, need frequent surveillance post treatment – up to four times per year in the first two years, then reducing to biannually, and annually after five years.

In particular, the grant will see the final validation of the MCM2 biomarker together with the company’s proprietary urine processing device and digital analysis system, in a multi-centred clinical trial within UK, EU and USA hospitals. The grant provides Cytosystems with the resources to gain a CE Mark and FDA approval for BladderLight™.

Richard Berry, CEO of Cytosystems, said: “This grant will allow the company to fully validate its technologies, and prepare for full commercialisation. Having already completed a number of trials where we have demonstrated the clinical efficacy of the BladderLightTM test, this grant will allow us to take the company forward and fully exploit the available commercial opportunities.”

Dr. Nigel McLean, Director of Product Management from Cytosystems, added: “A wealth of previous studies has highlighted the benefits of our technology. Not only can it improve diagnosis and ultimately patient care, but is also far less invasive for patients. In addition, we believe there are significant cost benefits associated with the adoption of our technologies for the surveillance of patients having received treatment for bladder cancer.”

-ends- 

For further information, please contact: 
Tony Stephenson
Exitus Communications
Tel: +44 (0)7899 796655
Email: This email address is being protected from spambots. You need JavaScript enabled to view it. 

Notes to Editors: Cytosystems is a clinical stage diagnostic development company, currently focussed on the development of technology for the diagnosis and management of urological cancers such as bladder and prostate cancer.  The company has developed a novel technology for urine cytology called BladderLight™, that enables a diagnosis with very high accuracy, that is non-invasive thus more acceptable to patients than the current invasive procedure. Cytosystems was established in 2006, and has been developing new diagnostic technologies that not only improve diagnosis and management of bladder cancer, but are also more acceptable to patients, by being less intrusive. www.cytosystems.com

Scotland: continuing to break the medical mould

Link to full article: Scottish Development International

Scots ideas are widely-acknowledged as providing the building blocks of much of modern medicine. As our latest crop of healthcare technologists head for Medica 2015, what’s behind that history of innovation and how is it shaping up today? If Scottish-born Alexander Fleming hadn't been such an untidy scientist, we would never have the life-saving drugs we have today. His discovery of a mould growing in one of his culture dishes that killed the surrounding bacteria prompted one of the greatest medical breakthroughs of the 20th century.

Fleming was not the only Scots pioneer. In fact, the start of innovation in healthcare is inextricably linked to the 18th century Scottish Age of Enlightenment. Scientific and medical knowledge was one its central pillars. Many of the key thinkers were trained as physicians or had studied science and medicine at university. Unlike England or European countries like France or Austria, their thinking was not restricted by powerful aristocratic patrons.

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A rich ecosystem

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Cytosystems is another very contemporary pioneer, with an idea to greatly improve existing bladder cancer tests, without disrupting work practices. In the words of Nigel Mclean, their product manager. “Following on from the extremely encouraging results of our initial 1,000 patient clinical trial for a urine-based diagnostic test for bladder cancer, Cytosystems is rapidly moving towards gaining MHRA and FDA approval.  Securing a multi-million pound source of funding has given us the resources required to complete a phase 2 multi-centred clinical trial and achieve MHRA and FDA approval."  

Surrounded by support

"Cytosystems is benefiting from being based in Scotland as a result of being close to major markets via our proximity to international airports.  We draw upon the talent within local universities, teaching hospitals, and SME’s together with the support from various innovation grants which help to support early-stage projects through to assistance with reaching out to the market once products are at the commercialisation stage. " - Nigel McLean, Cytosystems.

Cytosystems Ltd launch new website

In celebration of project progress, Cytosystems Ltd have launched a new company website. The new website is accessible at www.cytosystems.com.

The aim of the new website is to better tell our story. We are a non-invasive cancer diagnostics company situated in Aberdeen, whose main vision is to improve the patient experience. We are excited about the progression of our product BladderLightTM and we thought we ought to devote a page explaining why. We have also added a page to pay tribute to all of the organisations who have made Cytosystems Ltd such a success, whether directly or indirectly: http://www.cytosystems.com/index.php/links.

Our website is divided into separate sections depending on your interests:

  • For clinicians we explain our scientific development in the Clinical Technology section so you can understand why our technology will benefit healthcare professionals and patients alike.
  • For industry please see our product progression in our Products section which explains the potential of our technology.
  • For general information about the company you can follow our news feed or visit our publications.

You can also stay in touch by following our LinkedIn page. Overall, we hope that your visit to www.cytosystems.com will be an enjoyable one. If there’s anything else you would like to discuss please contact us – for general enquiries click here, and for partnering enquiries click here

We thank you for visiting our website and hope to see you again soon. 

With thanks, 

The Cytosystems Team

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