HIGHLY-ACCURATE URINE TEST WHICH RULES OUT BLADDER CANCER BEING OFFERED FREE TO NHS TO HELP CLEAR COVID-19 BACKLOG

Test for cancer hallmark MCM5 more effective at ruling out disease than current gold standard

Sunderland, United Kingdom, Thursday 23 July 2020 – A HIGHLY accurate urine test which can rule out bladder cancer with a negative-predictive value (NPV) of 99%^1,2 using a hospital laboratory’s standard ELISA testing equipment is today being offered free to the NHS to help urologists clear the backlog of people waiting for a diagnosis and monitoring as a result of COVID-19 hospital closures.

Clinical trials involving approximately 3,000 patients have shown that ADXBLADDER, made by UK-based Arquer Diagnostics, is a simple and painless test enabling urologists to confidently exclude the presence of high-risk bladder cancer. New data being presented at the European Association of Urology congress at the end of July and recently published in the Journal of Urology reinforces the rigorous clinical trial results investigating the urinary biomarker protein MCM5  (Minichromosome Maintenance Complex Component 5), which show that ADXBLADDER can exclude the presence of bladder cancer with an NPV of 99% in newly diagnosed patients and those who require recurrence monitoring.^3,4 ADXBLADDER has been shown to detect twice as many tumours as cytology in recurrence monitoring.^1,2

ADXBLADDER is a game-changing test - the first of its kind which uses patented technology to detect MCM5 in the urine, which makes it different to urine tests that have come before such as NMP22. All cancer cells – in every cancer type – are continually dividing (replicating) so contain MCM5. When a tumour is present in the bladder, these cells are shed into the urine and so the urine will contain the MCM5 biomarker. An important feature of ADXBLADDER is that the test is not influenced by infections or inflammation as bacteria do not contain MCM5 proteins and inflammatory cells cannot replicate so do not express the MCM5 protein. ADXBLADDER fits in a standard ELISA (enzyme-linked immunosorbent assay) machine widely available in NHS hospital labs.

Mr Tim Dudderidge, a Consultant Urological Surgeon at University Hospital Southampton who specialises in uro-oncology, said: “ADXBLADDER is different to previous cancer urine tests as it’s a new way of looking for cancer. The reason an MCM5 test is so powerful is that it gives us a message about uncontrolled cellular growth, which is the hallmark signature of cancer. If cancer is present, so is MCM5. Having a test like this is a great advance, allowing us to rule out cancer with very high accuracy and also helping improve how we monitor bladder cancer in patients for any recurrence.”

Recent figures from Cancer Research UK (CRUK)⁵ have shown that more than two million people in the UK were left waiting for cancer screening, tests and treatments in the first 10 weeks of lockdown alone and an estimated 290,000 people also missed out on an urgent suspected cancer referral for further tests in those 10 weeks, a time period during which 20,300 cancers would normally be caught.⁵

Arquer is making thousands of its tests available free of charge to all NHS hospitals until the end of September to help urologists quickly assess patients with suspected bladder cancer and ease the ongoing cancer diagnosis crisis caused by COVID-19.

Mr Stuart McCracken, Clinical Lecturer and Honorary Consultant Urologist, Newcastle University and Sunderland Royal Infirmary, said: “COVID-19 has had a devastating impact on cancer services around the country. A simple, non-invasive urine test such as ADXBLADDER can be used to swiftly identify patients at risk of bladder cancer recurrence, and who require follow-up tests, but also confidently identify those patients not at risk, who can therefore be reassured and reviewed at a later date, when the current COVID-19 risk is lower. We now have a unique opportunity to look at the cancer pathways we are currently using, which have changed completely in a very short period of time. Rather than going back to where we were pre-COVID, there is now an opportunity to change them for the better, building on and perfecting what we have been doing during lockdown.”

Bladder cancer affects more than 10,000 people a year in the UK⁶ according to CRUK and kills more than 5,400. Less than half of those diagnosed (46%) survive for 10 years or more⁶. It is thought around 18,000* people already referred to a hospital urologist for suspected bladder cancer have not been tested because cystoscopy, ultrasound and face -to-face consultations were all cancelled and postponed as part of the NHS-wide pandemic response. Experts are now warning that urology departments could take at least a year to get through the backlog if they only use cystoscopies which could lead to those who may have the disease missing out on urgent treatment, with potentially fatal consequences.

National Institute for Health and Care Excellence (NICE)⁷ guidelines state that everyone with any suspected cancer should have their first referral appointment within two weeks but this target is thought to have slipped by at least 75%⁶ during lockdown. NICE also recommends that all patients with blood in their urine should be offered a cystoscopy, followed up by other tests such as an ultrasound if necessary. However, cystoscopy can miss up to 30% of bladder tumours ^8,9 and is an uncomfortable, invasive and sometimes painful procedure.

Arquer also believes the new test has the potential to save the NHS money with internal research showing that it is up to 42% cheaper than existing options which would save around £800 per patient over two years.

Mr Dudderidge added: “A 99% NPV is very high and can definitely help urologists have peace of mind that if a patient is negative for this test that they can be seen for a cystoscopy further down the line. This isn’t about replacing cystoscopy but about reducing the unnecessary ones especially now we have such a huge backlog. There is a way we can reduce the frequency of them by modifying the pathway which could halve the number of unnecessary cystoscopies a patient has to undergo by using ADXBLADDER as well. Cystoscopy is an uncomfortable, invasive, and sometimes painful test to go through. And if the test is negative patients can see that as a wasted episode. But we as doctors need to make sure that this disease hasn’t returned. ADXBLADDER has a biological USP different to any of its predecessors. This is a really unique and very sensitive way to rule out malignancy and its very high NPV is incredibly important.”

Nadia Whittley, Chief Executive Officer of Arquer Diagnostics, said: “We have all heard about the devastating impact that COVID-19 has had on cancer services across the UK. Our ADXBLADDER test is quick, painless and can rule out bladder cancer with 99% accuracy because it works by detecting a cancer protein which would be shed into the urine if a tumour was present. 

"At a time when urology services are desperately trying to work through a backlog of thousands of patients who are waiting to find out if they have bladder cancer or if their disease has returned, we are offering as many tests as the NHS needs free of charge  to quickly determine which patients are clear of the disease and which need further tests.

“Every single person waiting for a diagnosis deserves not to have to wait any longer for peace of mind that they are cancer-free or to be able to begin vital treatment if required. Urologists should get in touch with Arquer Diagnostics as soon as possible and we can then make the tests available to their hospitals and clinics.”

*110,000 cystoscopies a year = 9,000 per month. Three months of lockdown with only 30% capacity = around 18,000 missed

ENDS

NOTES TO EDITORS:

Full background documents on ADXBLADDER, bladder cancer and Arquer Diagnostics are available on request along with details of case studies.

For further press information please contact The Difference Collective arquer.comms@thedifferencecollective.com

For further information on Arquer Diagnostics please visit https://arquerdx.com/

About ADXBLADDER

• ADXBLADDER is a game-changing test - the first of its kind which uses patented technology to detect the biomarker protein MCM5 (Minichromosome Maintenance Complex Component 5) in the urine which is present when cells grow uncontrollably.
• Normal, healthy cells ‘switch off’ and stop growing. These cells, such as those lining the bladder and which are in contact with the urine, do not contain MCM5. But the cells which continue to grow and cause cancer do contain MCM5.
• If ADXBLADDER cannot detect MCM5 in the urine it is highly likely that cancer is not present. If urologists and oncologists do suspect cancer, they can then investigate further, using cystoscopy and tissue biopsy.
• ADXBLADDER is a highly accurate, simple, fast and painless urine testing kit which can rule out bladder cancer with up to 99% accuracy ^1,2.
• After a urologist requests ADXBLADDER, a patient provides them with a urine sample which is then sent to the hospital laboratory. After undergoing a series of steps to isolate any MCM5 cells present, the sample is then put into the ADXBLADDER sample plate which fits in a standard ELISA (enzyme-linked immunosorbent assay) machine that is widely available in NHS hospital labs.
• A chemical enzyme then colour-codes any MCM5 present in the sample. If there is no colour change this accurately rules out bladder cancer.
• The test takes just 2.5 hours once in the lab and urologists will typically get the results back in a number of days.

About Bladder Cancer

• Bladder cancer is a disease in which the cells lining the urinary bladder lose their ability to regulate growth and start dividing uncontrollably. This abnormal growth results in a mass of cells that form a tumour.
• According to CRUK, bladder cancer affects more than 10,000 people a year in the UK and kills more than 5,400^. Less than half of those diagnosed (46%) survive for 10 years or more⁶.
• The majority of bladder cancer patients (around 76%) are diagnosed early at stage I or II when the disease is more treatable. However, between 24 to 28% are diagnosed at stage III or IV and between 17% and 20% already have metastases at diagnosis (stage IV)⁶

About Arquer

• Arquer Diagnostics is a UK-based company committed to manufacturing and marketing innovative, non-invasive cancer tests for diagnosis and monitoring.
• Arquer’s approach and tests are supported by highly-regarded experts at leading international organisations: University Hospital Southampton and Sunderland Royal Hospital in the UK; Pitié Salpêtrière University Hospital and Hôpital Edouard Herriot, Lyon in France; University Hospital Fundació Puigvert in Spain; Radboud University Medical Centre, Nijmegen in The Netherlands; as well as Ospedale Molinette, Turin, and Universita’Policlinico Milano, in Italy.

Biographies of Mr Stuart McCracken and Mr Tim Dudderidge – interviews available on request

• Mr Stuart McCracken is a consultant urologist. He studied at Nottingham University Medical School and after basic surgical training, he undertook a period of research focusing on targetable molecular pathways in advanced prostate cancer leading to the award of a Doctor of Philosophy (PhD). His urology training was undertaken in the North East where Stuart is now a Senior Lecturer and Honorary Consultant Urological Surgeon, dividing his time between Newcastle University and Sunderland Royal Hospital. He sits on the Executive Board of the Academic Section of the British Association of Urological Surgeons.

• Mr Tim Dudderidgeis a highly trained consultant urologist based in Southampton, who specialises in urological cancer diagnostics. Mr Dudderidge qualified from the University of Bristol and trained in London at King's College Hospital, University College Hospital, Imperial Healthcare and the Royal Marsden Hospital. He embarked on a Royal College of Surgeons Uro-Oncology Fellowship at Imperial in 2009 and subsequently was the UK’s First Robotic Surgery Fellow at the Royal Marsden. His training has also included a two-year research period as Lecturer in Molecular Uro-Pathology, for which he was awarded two masters degrees. He also holds an MD (Doctor of Medicine) from the University of Bristol for his work on "Minichromosome Maintenance Proteins (MCMs) in Urological cancer Management".
  
  

REFERENCES

1. Dudderidge T, et al. A Novel, non-invasive Test Enabling Bladder Cancer Detection in Urine Sediment of Patients Presenting with Haematuria—A Prospective Multicentre Performance Evaluation of ADXBLADDER. Eur Urol Oncol (2019), https://doi.org/10.1016/j.euo.2019.06.006
2. Roupret M, Gontero P, McCracken SRC, et al. Diagnostic Accuracy of MCM5 for the Detection of Recurrence in Non Muscle Invasive Bladder Cancer Follow up: A Blinded, Prospective Cohort, Multicentric European Study [published online ahead of print, 2020 Apr 21]. J Urol. 2020;101097JU0000000000001084. doi:10.1097/JU.0000000000001084 https://pubmed.ncbi.nlm.nih.gov/32314931/
3. Diagnostic performance of MCM5 testing in the diagnosis of recurrent bladder cancer: results from a large prospective, blinded, multicentric European study. Roupret et al (Jul 2020*)
4. Evaluation of ADXBLADDER and Cytology performance in the follow up
   of NMIBC: a blinded prospective multicentric. Gontero et al (July 2020*)
5. https://www.cancerresearchuk.org/about-us/cancer-news/news-report/2020-07-08-urgent-cancer-referrals-being-turned-down-during-coronavirus-pandemic
6. https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bladder-cancer
7. https://www.nice.org.uk/guidance/NG12/evidence
8. Daniltchenko D. Long-term benefit of 5-aminolevulinic acid fluorescence assisted transurethral resection of superficial bladder cancer: 5-year results of a prospective randomized study. J Urol. 2005;174:2129–33.
9. Denzinger S. Clinically relevant reduction in risk of recurrence of superficial bladder cancer using 5-aminolevulinic acid-induced fluorescence diagnosis: 8-year results of prospective randomized study. Urology. 2007;69:675–9.