HIGHLY-ACCURATE URINE TEST WHICH CAN RULE OUT BLADDER CANCER TO HELP CLEAR COVID-19 BACKLOG

Simple and painless urine test being offered for free to NHS

Sunderland, United Kingdom, Thursday 23 July 2020 –A SIMPLE, highly accurate and painless urine test which can rule out bladder cancer in just a few hours is today being offered free to the NHS to help doctors clear the backlog of people waiting for diagnosis or monitoring as a result of COVID-19 hospital closures. 

Recent figures from Cancer Research UK (CRUK)[i] revealed that more than two million people in the UK were left waiting for screening, tests and treatments for all cancers 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. 

The UK-based company behind the ADXBLADDER test, Arquer Diagnostics, is making thousands of its tests available free of charge to NHS hospitals across the UK until the end of September to help patients with suspected bladder cancer be quickly assessed. Rigorous clinical trials have shown that ADXBLADDER is able to rule out cancer 99%[ii],[iii]  of the time, without any other standard diagnostic testing. The usual tests include cystoscopy, which sees a tube with a camera inserted into the bladder, and cytology, a test that looks at cells under a microscope. ADXBladder can be used at the diagnosis referral stage to rule out the presence of cancer and at follow-ups to monitor whether cancer has returned.

Bladder cancer affects more than 10,000 people a year in the UK[iv] according to CRUK and kills more than 5,400. Less than half of those diagnosed (46%) survive for 10 years or more2. It is thought around 18,000* people already referred to a hospital urologist for suspected bladder cancer have not been tested because the usual diagnostic tools of cystoscopy and ultrasound as well as face -to-face consultations were all cancelled or 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.

Mr Stuart McCracken, Clinical Lecturer and Honorary Consultant Urologist, Newcastle University and Sunderland Royal Infirmary, said: “The impact COVID-19 has had on cancer services has been devastating and we must act quickly to ensure that any patient who has missed out on an appointment is seen as soon as possible. We know those most at risk of many cancers, including bladder, are also those most vulnerable to catching, and dying from, COVID-19. A test such as ADXBLADDER is quick, simple and highly accurate which means we can use it swiftly to work out those more likely to need follow-up tests and those who can wait until the COVID-19 risk is lower.” 

NHS guidelines from the National Institute for Health and Care Excellence (NICE)[v] state that everyone with any suspected cancer should have their first referral appointment within two weeks but experts fear this target has slipped by at least 75%1 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[vi],[vii] and is an uncomfortable, invasive and sometimes painful procedure, plus it has to be conducted within a hospital setting thereby exposing patients to an increased risk of contracting COVID-19.

ADXBLADDER is a game-changing test which can detect a hallmark cancer biomarker protein called MCM5 (Minichromosome Maintenance Complex Component 5) in the urine. If ADXBLADDER cannot detect MCM5 in the urine it is highly likely that cancer is not present. If it is present, urologists can then investigate further, using cystoscopy and tissue biopsy. A urologist asks a patient to provide a urine sample which is then tested using ADXBLADDER in a standard ELISA (enzyme-linked immunosorbent assay) machine that is widely available in NHS hospital labs. The test takes just two and a half hours once in the lab and urologists will typically get the results back in a few days. It also has the potential to save the NHS money, as this test relies on a very cost-effective technology. 

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.”

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.”

Anita Brown, 49, from Hampshire had to wait over a year to be diagnosed with bladder cancer, by which time her tumour had already grown through the bladder lining and begun to affect her lymph nodes, liver and had spread to her bones meaning her disease was terminal. The mother-of-one had a long history of regular urinary tract infections (UTIs) and, after discovering blood in her urine, was eventually diagnosed with bladder cancer in 2016. Anita, who used to work as a carer but now writes her own blog, has had chemotherapy, radiotherapy and her bladder removed and now lives with a stoma bag to collect her urine. She is adamant that quick, early diagnosis is vital to ensure no one goes through what she has. 

She said: “If I had been offered a simple urine test early on, the doctor would have seen quickly that I was likely to have a tumour. Instead, I faced months of delays which meant by the time I was finally diagnosed, I was really unwell and the resulting treatment has been incredibly traumatic. Living with cancer is hard but it’s also becoming more common. I want everyone to have the opportunity to live well and early diagnosis is key to that, so I welcome this new test wholeheartedly.”

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

Arquer Diagnostics Announces Exclusive Agreement with SYNLAB to Accelerate the Introduction in the UK of Game-Changing non-invasive Diagnostic test for Patients with Suspected Bladder Cancer

Sunderland, United Kingdom, 13th July 2020 – Arquer Diagnostics, a UK-based company committed to manufacturing and marketing innovative, non-invasive tests for diagnosing and monitoring cancer, today announced that it has entered into an exclusive agreement with SYNLAB UK & Ireland, a leading medical diagnostic services provider.  

The agreement will provide access for UK-based urologists to ADXBLADDER, a urine test for people with suspected bladder cancer and those being monitored for recurrence. The full details of the deal remain confidential.

ADXBLADDER, the diagnostic test at the center of the agreement between Arquer and SYNLAB, is a game-changing urine test which can rule out the presence of bladder cancer with an extremely high level of accuracy both in patients showing signs of the disease and in patients undergoing monitoring for possible recurrence. 

In the UK, around 10,200 patients are diagnosed with bladder cancer each year 1, with some 5,400 people dying annually from the disease 2.

Patients who have had bladder cancer currently undergo up to four invasive cystoscopies each year to check for recurrence, meaning multiple visits to hospitals and unpleasant tests. The rigorous clinical trials run with ADXBLADDER show the non-invasive test is quicker, highly accurate and potentially, cheaper than the current standard diagnostic.

SYNLAB will provide a “collection kit” to urologists so that their patients will be able to send their urine sample directly to the SYNLAB laboratory for analysis: a simple method to provide a much needed service to bladder cancer patients 

Arquer CEO, Nadia Whittley, commented, “This agreement allows our innovative and game-changing urine test to reach the right people at the right time. ADXBLADDER gives urologists a valid tool to use in combination with cystoscopy, and with SYNLAB’s expertise and experience in laboratory analysis, we will make sure this test becomes part of their toolbox.”

SYNLAB UK & Ireland Chief Medical Officer Dr David James commented “SYNLAB are pleased to work with innovative companies such as Arquer Diagnostics in enabling patient access to cutting edge testing which can make a positive impact on patient’s lives”. 

As well as bladder cancer, Arquer’s breakthrough technology is showing positive early data in the diagnosis of prostate and endometrial cancers. The company is currently undertaking clinical evaluation of the technology in these additional tumour indications.

ADXBLADDER: A Novel Non-Invasive Aid for Bladder Cancer Monitoring

The innovative Arquer Diagnostic urine test for bladder cancer adds recurrence monitoring to the approved indications

Sunderland, January 22nd 2019. After succesfully launching ADXBLADDER urine test for the detection of bladder cancer, Arquer Diagnostics announces today the addition of bladder cancer recurrence monitoring as a new indication for use.
“The clinical data supporting this new indication are very consistent with the results observed in all our clinical studies” observes Nadia Whittley, CEO of Arquer Diagnostics. “The reproducibility of the results on a large patient population is a strong indicator of the effectiveness of this diagnostic test. We are now completing the 2000 patients multicentric European study, and the high sensitivity, especially in high grade tumors, coupled with unprecedented negative predicted value continue to be observed, giving our clinical study investigators high confidence in the performance of the test.”

ADXBLADDER measures levels of the MCM5 protein, which is a marker of cells that are replicating, or still have the capability to replicate (i.e. are not terminally differentiated). Such cells are normally only found in basal layers of the epithelium, but when a mass of replicating cells is present (as occurs in bladder cancer), MCM5 cells are shed into bodily fluids. MCM5 in the urine is indicative of undifferentiated cells in an inappropriate location. Detection utilizes standard Enzyme Linked ImmunoSorbent Assay (ELISA) methodology, using mouse monoclonal antibodies to identify MCM5 antigens.

ADXBLADDER is clearly performing consistently across a large population and is demonstrating very exciting results in the detection of recurrent disease- particularly high grade tumours that are at high risk of progression.” said Prof Palou , PI of the ongoing European Study from Fundacio Puigvert Barcelona.

ADXBLADDER is available in all European countries; for more information consult the Arquer Diagnostics web site.

For further information:

Corporate & Clinical Enquiries:

Arquer Diagnostics +44 (0) 191 516 6765
info@arquerdx.com
www.arquerdx.com

About Arquer Diagnostics Ltd

ADXBLADDER, a non-invasive bladder cancer diagnostic test, is the first product to be launched by Arquer Diagnostics. Arquer Diagnostics, launched in 2015, is a company based on the development of non-invasive cancer diagnostic tests using the MCM5 (minichromosome maintenance protein) platform. The mission of Arquer Diagnostics is to deliver accurate, rapid, minimally invasive oncology diagnostic products. Arquer Diagnostics, who are headquartered in Sunderland, United Kingdom, are supported by an international medical advisory board. ADXBLADDER is currently commercialized in Europe and will be further released to other regions in 2019.

Step change in oncology diagnostics

Arquer Diagnostics is developing a series of innovative, non-invasive tests for cancer and recently launched ADXBLADDER, a reliable urine test for bladder cancer.

Non-invasive cancer diagnostic tests could offer simpler, more reliable and less costly alternatives to current approaches, eliminating the need for invasive tests and improving the patient experience. Arquer Diagnostics is developing and delivering innovative oncology diagnostic products based on the detec- tion of a cancer biomarker, minichromosome main- tenance protein 5 (MCM5).

Read the full document here

Arquer Diagnostics Wins Outstanding Industry Collaboration at Bright Ideas in Health Awards

Newcastle, 17th November 2017: Arquer Diagnostics are proud to announce their status as Winners of the Outstanding Industry Collaboration with the NHS category at the 2017 Bright Ideas in Health Awards, which took place in Newcastle this week.

These prestigious awards celebrate the achievements of individuals and teams working within the NHS, industry and academia, who have risen to the challenge of showing how and where improvements to patient service can be improved, either through technical innovation or better service delivery.

Arquer Diagnostics in partnership with the teams at Sunderland Royal Hospital, South Tees Hospitals NHS Foundation Trust and Cumbria NHS Trust submitted their entry for ADXBLADDER – a breakthrough, non-invasive urine test for bladder cancer – for the Outstanding Industry Collaboration with the NHS award. This category recognises industry and NHS collaborations which address a significant need and will have a major impact and benefit for patient care versus previous treatments – including reduction in treatment time, cost savings etc.

“This industry collaboration award recognises Arquer’s vision and its commitment to deliver transformational change in oncology diagnostics,” says Nadia Whittley, CEO of Arquer Diagnostics. “By working with leading NHS clinical teams in the North East and throughout the UK, we are proud to have developed a unique and innovative solution with ADXBLADDER, delivering simple, accurate and non-invasive testing for bladder cancer. This is only the beginning: more NHS Trusts have been engaged to work on new cancer diagnostic tests which we hope will have a major positive impact on the lives of cancer patients worldwide”. 

Present at the awards ceremony were representatives of the Arquer Diagnostics team – Nadia Whittley, Tristan Sillars and Louise Flintoft, alongside representatives of the partnership NHS institutions – Mr Stuart McCraken, Consultant Urologist at Sunderland Hospital, Sue Asterling, Urology research nurse, and Jo Cresswell, Consultant Urologist at James Cook University Hospital.

Non-invasive urine test provides game changer in bladder cancer

New Bladder Cancer diagnostic test provides a unique combination of high sensitivity and negative predictive value

Lisbon, Portugal 21st October 2017. A new non-invasive urine test for bladder cancer providing a clear cut ‘yes/no’ result within three hours was launched at the 37th Société Internationale D’Urologie (SIU) meeting in Lisbon, Portugal, October 19-22, 2017. A study involving 577 patients, presented at an SIU symposium* today, showed the ADXBLADDER test was extremely reliable, demonstrating a sensitivity of 95% for higher risk cancers and a negative predictive value greater than 97%. The ADXBLADDER, produced by Arquer Diagnostics, received its CE Mark on 11th October 2017.

ADXBLADDER is a real game changer in the field of bladder cancer testing. Our data demonstrates ADXBLADDER has one of the highest sensitivities and negative predictive values of any urine test for bladder cancer diagnosis and additionally offers innovative features, such as the result being unaffected by urinary tract infections (UTIs) and no requirement for samples to be sent away to specialist labs for analysis,” said Mr. Stuart McCracken, the study principal investigator.

ADXBLADDER has the potential to make non-invasive testing for bladder cancer a clinical reality. It could help to diagnose patients earlier in the disease and offer dramatic improvements in quality of life and safety by reducing the need for cystoscopy and CT scanning,” said Mr. Tim Dudderidge, a study investigator.

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