Female Bladder Cancer Array

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Female Bladder Cancer Array

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Female Bladder Cancer Array

Improved Risk Stratification of Haematuria Patients

Identify Individuals at Greatest Risk of Bladder Cancer

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    Improve management of patients with haematuria, reduce unnecessary investigations and refer those at greatest risk of bladder cancer for urgent cystoscopy.
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    Simultaneous detection of four novel biomarkers from a single urine sample to determine an individuals biomarker risk score.
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    Determine overall bladder cancer risk by combining biomarker risk scores with clinical risk scores generated using our complex algorithms.

There is an urgent critical need for additional evidence-based risk stratification models to inform triage and/or management decisions for patients presenting with haematuria. Current diagnostic methods such as cystoscopy  and cytology are invasive, carry risks for the patient and have several limitations.

In addition, existing biomarkers lack specificity and may fail to differentiate between all possible causes of haematuria. Utilising patented biochip technology, the female bladder cancer array will allow accurate risk stratification of female patients presenting with haematuria. Bladder cancer is the 8th most common cancer in females, although more common in males mortality is twice as high in females highlighting the need for alternative diagnostic methods.

Clinical patient pathway using the Randox Biochip Technology to reduce cystoscopy burden allowing patients at greatest risk to be triaged for urgent cystoscopy.
Clinical patient pathway using the Randox Biochip Technology to reduce cystoscopy burden allowing patients at greatest risk to be triaged for urgent cystoscopy.

Biomarkers Tested 

  • IL12p70
  • IL13
  • Midkine
  • Clusterin

Interleukin-12 p70 (IL12p70) is a disulphide linked heterodimeric cytokine which regulates inflammation by linking innate and adaptive immune responses and potent inducer of antitumor immunity.  

Interleukin-13 (IL-13) is an immunoregulatory cytokine which plays an important role in carcinogenesis through affecting tumor immunosurveillance. IL-13 in the bladder cancer patients suggests that this cytokine is involved in progression in bladder cancer patients.

Midkine is a member of a family of heparin-binding growth factors, which was reported to have an important role in angiogenesis and is associated with bladder cancer progression.


Clusterin is conserved glycoprotein that has been distinguished from human fluids and tissues which plays a key role in cellular stress response and survival. It is in cancer metastasis, which is particularly important to design the strategies for treating metastatic patients.




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Developed for use on the Evidence Investigator, a semi-automated benchtop immunoassay analyser.

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    Cost effective and efficient multiplex testing solution
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    Comprehensive immunoassay & molecular test menu available
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    Limited sample volume requirement
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    Medium to high throughput
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    Suitable for clinical and research testing
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New Randox project committed to helping bladder cancer patients

Scientists at global healthcare company Randox, recently unveiled as the sponsors for The Grand National 2017 under the banner of Randox Health, today announced the company has been awarded an Innovate UK research award, for their pioneering work in the development of a diagnostic test for the detection of bladder cancer in haematuria patients.

The urine-based test is being developed in collaboration with The Belfast Trust and Queen’s University Belfast, and has been described by the project’s Lead Scientist at Randox, Dr Mark Ruddock, as the “holy grail” of diagnostic tests to stratify patients with haemeaturia (blood in the urine), who are at high risk of bladder cancer;

“Currently, all haematuria patients are ‘red-flagged’ as candidates for an invasive procedure called a cystoscopy (a camera inserted into the bladder), which is both embarrassing and uncomfortable for the patient.    In comparison, the revolutionary Randox test is based on a simple urine sample so is non-invasive and much more comfortable for the patient.”

 Considering less than 20% of patients with visible haematuria, and less than 5% with invisible haematuria are found to have bladder cancer,   Dr Ruddock highlighted the urgent need for a test that can inform decisions for patients who present with haematuria;

“In the UK, over £33.5 million is spent each year managing patients with haematuria who are subsequently found not to have bladder cancer.  As such, haematuria is a significant healthcare burden, which is only set to increase because of our aging population.  Use of this new test will allow urology teams the opportunity to reduce the number of unnecessary cystoscopies carried out on patients identified as ‘low risk’, and stratify patients identified as ‘high risk’.  This will result in significant healthcare savings, and an improvement in the waiting times for haematuria patients who do require diagnostic services ie. those patients deemed ‘high-risk’.”

Randox was successful in winning funding for phase one of the project, which has enabled an economic study to be carried out by The National Institute for Health Research Diagnostic Evidence Co-Operative Leeds who will investigate the economic benefits of the new diagnostic test for The National Health Service, and its role in the current patient care pathway.  On successful completion of phase one, Randox will be eligible to apply for phase two funding.

Professor Peter Selby, Professor of Cancer Medicine at the University of Leeds, and Director of the NIHR Diagnostic Evidence Cooperative Leeds, said:

“Bladder cancer is a very important disease which can be life threatening but also in many patients it can generate great anxiety, frequent hospital visits and many investigations. The new approach being developed by Randox has the potential to save lives and improve the quality of lives of many people at risk of bladder cancer.”

“Diagnostic Classifier for risk stratification of haematuria patients” was selected by Innovate UK in the “Stratified Medicine: connecting the UK infrastructure” competition.

New Randox project committed to helping bladder cancer patients