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).

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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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Arquer Diagnostics announces commercial partnership agreement for UK and Ireland

Arquer Diagnostics Ltd (“Arquer”), an in-vitro diagnostic company, developing breakthrough diagnostic tests for the detection of bladder and prostate cancer, announced today a strategic commercial partnership with Alpha Laboratories, who will take over the distribution of Arquer products across the UK and the Republic of Ireland.

Alpha Laboratories has been providing quality supply and support to UK and international scientists servicing their diagnostic and laboratory product needs for many years.

Based in Southampton, UK, the company has a strong reputation of quality and science, developed through many innovative product launches over the last 40 years. The energetic team is passionate about finding novel ways to help science improve people’s lives, through their evolving range of specialist Diagnostic and Laboratory Products.

“One of the key elements of the success of any product launch is the quality of the technical and scientific support delivered to all stakeholders. I am extremely excited about the partnership with Alpha Laboratories, as they have an incredible track record of success and a reputation in the IVD field. The Arquer Diagnostics’ Team and I look forward to many years of success together with Alpha Laboratories”, says Nadia Whittley, Arquer CEO.

www.alphalabs.co.uk

Arquer Diagnostics raises £2.1 million in series B funding led by Longwall Venture

Arquer Diagnostics Ltd (“Arquer”), an in-vitro diagnostic company, developing breakthrough diagnostic tests for the detection of bladder and prostate cancer, announced today a series B investment of £2.1 million led by equity investor Longwall Ventures (“Longwall”). Longwall is investing £1 million, with additional funds coming from existing investors, including Esperante Ventures and many others.

The financing will fund the launch of ADXBLADDER, Arquer’s novel bladder cancer test based on the MCM5 ELISA technology, as well as funding a pipeline of clinical programs aimed at launching a series of new MCM5 based cancer diagnostic tests in the next 2 years.

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