Cytosystems receives ISO 13485 accreditation 

Cytosystems takes another step closer to delivering its’ lead product, BladderLight®, to market. 

Cytosystems has received ISO 13485 accreditation for the “design, manufacture and distribution of non-invasive laboratory based diagnostic tests for genitourinary cancers”. 

BladderLight® is a non-invasive urine based diagnostic and risk stratification assay for bladder cancer.  Ultimately, BladderLight® will reduce the need for patients to undergo cystoscopy, the current standard of diagnosis and monitoring for post treatment of bladder cancer.  Cystoscopy is an invasive and unpleasant technique; BladderLight® will benefit the patient, healthcare system, and allow clinical staff to focus on managing patients with / or having a high risk of bladder cancer.  


Cytosystems Invited to MEDICA Trade Fair

Cytosystems has been invited to attend the MEDICA trade fair brokerage and pitching events in Dusseldorf 13th-16th November through their involvement in the EU Horizon 2020 scheme. The €3.2million grant which was awarded in 2015 has allowed the company to continue in their development of bladder cancer diagnostics and look towards a full clinical trial of their first product BladderLight™.

To coincide with their attendance at the trade fair, a new brochure presented by Cytosystems describes, for the first time, their technology solution for bladder cancer stratification through their product BladderLight™. BladderLight™, an integrated and automated digital pathology solution for the diagnosis and monitoring of bladder cancer, marks a step-change in non-invasive bladder cancer diagnostics.

Comprising of three component technologies, BladderLight™ provides superior accuracy by optimising each step in the diagnostic workflow, mitigating the current limitations of urine cytology and biomarker analysis.

The brochure highlights Cytosystems’ technology for cell analysis and outlines the benefits of adopting BladderLight™. It is to be introduced into the public domain during the MEDICA trade fair in Dusseldorf. Please contact This email address is being protected from spambots. You need JavaScript enabled to view it. if you would like a copy.

MCM biomarker shows over 90% sensitivity for detection of bladder cancer; poster presentation at AUA'17, Boston

Mr. Kasra Saeb-Parsy BSc, MB BS, AFHEA, FRCSEd (Urol), Consultant urologist, Cambridge University Hospitals NHS Foundation Trust presented results of a 275-patient multi-centred UK clinical trial at this year’s AUA’17 in Boston. These revolutionary results, together with additional supporting data are now available to be viewed [HERE]

The study shows the MCM assay achieves a sensitivity of 95.8% and specificity of 91.7% in the gross hematuria clinic and 92.3%/80.3% in the surveillance clinic. These results highlight Cytosystems’ ground-braking technological developments and is catapulting clinical validation of the company’s new improved user friendly test.


Clinical trial results for MCM cytology based assay to be presented at AUA’17, Boston May 12


The ground breaking results of a 275-patient multi-centered UK clinical trial will be presented at this year’s AUA conference, in Boston by Mr. Kasra Saeb-Parsy BSc, MB BS, AFHEA, FRCSEd (Urol), Consultant urologist, Cambridge University Hospitals NHS Foundation Trust 

Mr. Saeb-Parsy, one of the PI’s in the study, will be explaining how the MCM assay can achieve a sensitivity of 95.8% and specificity of 91.7% in the gross hematuria clinic and 92.3%/80.3% in the surveillance clinic.  MCM is a Minichromosome Maintenance Protein involved with the regulation of cell replication.  Healthy cells found in urine do not express MCM, whereas cells expressing MCM are indicative of cancerous cells.  Recent developments which further improve the clinical utility, accuracy, and health economic aspects of the assay will be discussed.

The presentation concludes that MCM2 detection has the potential to be the basis for a reliable non-invasive test, for diagnosis of primary and recurrent urinary carcinoma, and may be used to stratify cases where there is no likelihood of disease i.e. zero false negatives, thus avoiding invasive intervention and resulting in quantifiable health economic benefits.


Poster details:

MP15-20: MCM-2 cell based assay is a sensitive and specific test for risk stratification of bladder cancer patients.

Friday, May 12  1:00 PM - 3:00 PM


Location: BCEC: Room 252

Boost for bladder cancer detection

A pioneering new method for the accurate diagnosis of bladder cancer is one step closer thanks to a £½ million funding boost.

The funding from the UK’s innovation agency, Innovate UK, will allow experts at the University of St Andrews to develop technology alongside Aberdeen-based diagnostic specialists Cytosystems.

Read the full article here

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