Cytosystems Ltd was set up in 2006 in Aberdeen, Scotland, to develop non-invasive, integrated diagnostic tests for bladder and prostate cancer. 

Since then, Cytosystems has successfully developed a unique urine-based screening and diagnostic platform technology for the detection of cancer of the bladder and the prostate based on using MCM (Mini-Chromosome Maintenance) protein antibodies.

The benefits over cystoscopy:

Bladder cancer

Cancer of the bladder is the fourth most common cancer in men and the seventh most common in women.  Current estimates are that up to 3.6 million cystoscopies for TCC (Transitional Cell Cancer of the bladder) are carried out each year in Europe and the USA, at considerable expense per test.
As well as being expensive to administer, cystoscopies are invasive and uncomfortable for the patient, requiring local or general anaesthetic, and post-treatment bladder cancer patients may have to undergo a large number of surveillance cystoscopies for life.

By contrast, Cytosystems’ MCM protein antibody diagnostics are non-invasive, capable of being managed in the surgery or out-patient department, and, based on results achieved to date, have the potential to reduce cystoscopies by up to 60%.

Prostate cancer

Prostate cancer is the single largest cancer affecting men globally with over 500,000 new cases diagnosed annually of which over 190,000 are in the USA and 21,000 in the UK.

Existing diagnostic practice utilises prostate-specific antigen (PSA) serum testing, which is widely accepted to be unsatisfactory since as many as two-thirds of patients showing raised PSA levels will not have prostate cancer.  The problem is that this large group of patients have to undergo the same follow-on invasive procedures, which can include multiple blind biopsies of their prostate gland, as the 30% who will have prostate cancer.   It is hoped that once validated the Cytosystems test will significantly reduce the requirement for blind biopsies in this group of patients who will not have prostate cancer.  The benefits to patients and healthcare providers are evident and should be significant.

By contrast, a recent 82-patient clinical trial at Addenbrookes Hospital, Cambridge, gave impressive results:

• All patients with known prostate malignancy were prostate cell and MCM positive
• All patients with low PSA were prostate cell positive but MCM negative
• All females were MCM and prostate cell negative

Despite the acknowledged insensitivity of PSA, approximately 19 million screening alone tests using PSA are carried out annually in the US.

Utilising Cytosystems’ MCM protein antibody diagnostics, based on non-invasive screening using urine as an analyte, it is anticipated that significant reductions in both the quantity and the cost of blind biopsy procedures will be realised.

Other advantages

Based on other applications of MCM protein antibody diagnostics, one of the primary anticipated benefits of this technique in the detection of bladder cancers is the reduction in the number of false negative results – a phenomenon which has been described as “biologically unique”. (False negative results can run as high as 30% in conventional cytology for other cancer-based disease.)

The other main advantages of Cytosystems’ MCM protein antibody diagnostics for the detection of bladder and prostate cancer are:

• Rapid laboratory-based test procedures using conventional liquid-based cytology (LBC) and therefore utilising existing laboratory equipment
• Reliable reproducible data with consistent and clear results

Cytosystems’ unique diagnostics technique – “the Cytosystems solution” - comprises four distinct but integrated components:

• A urine collection device
• A set of six urine collection protocols to optimise cell harvesting
• The underpinning Cancer Research Technology MCM antibody
• An automated slide reading system

“It is a great tribute to the abilities and tenacity of our management team and our scientific advisory board that we have been able to undertake two major clinical trials in a relatively short space of time to validate Cytosystems’ screening and diagnostic tests for both bladder and prostate cancer,” says Richard Berry, Chief Executive of Cytosystems Ltd.