News and Events

Arquer Diagnostics Named As Finalists in “Bright Ideas In Health Awards” with ADXBLADDER

Arquer Diagnostics is delighted to announce our status as shortlisted finalists for the NHS’s Bright Ideas in Health Awards 2017. The entry, “A Non-Invasive Urine Based Test for Bladder Cancer” has earned a place in the “Outstanding Industry Collaboration with the NHS” category.

About the Bright Ideas In Health Awards

Now in it’s 14th year, these awards celebrate the achievements and successes of teams or individuals within the industry, academia and the NHS. Entrants all have one thing in common: they believe that improvements can and need to be made to patient services, either through changing service delivery or through technical innovation.

This is where the Arquer DX team have excelled and been recognised by the judges, through the development of ADXBLADDER: a non-invasive, reliable, cost-effective, and accurate alternative to the traditional cystoscopy test for bladder cancer.

The “Outstanding Industry Collaboration with the NHS” Category

This category specifically recognises new developments which have been created through industry and NHS collaborations, and have delivered significant benefits to NHS patients compared to current standard of care treatments.

In the case of ADXBLADDER, the Arquer Diagnostics team have developed a real game changer in bladder cancer diagnosis. The test has been clinically proven to demonstrate fantastic accuracy and could have a key role in helping identify bladder cancer patients earlier, which may have a positive impact on survival.

The Arquer DX Team

This finalist status is a testament to the hard work and dedication of the entire Arquer Diagnostics team and we are delighted to see that our passion and commitment to improving diagnostic standards and patient care has been recognised in this award listing.

The awards evening will take place at the Hilton Hotel Newcastle Gateshead on Wednesday November 15th where our team look forward to celebrating the achievements throughout the industry. Wish us luck!

For more information on what we are trying to achieve at Arquer Diagnostics, or the launch of ADXBLADDER, please visit our website, and be sure to follow us via our social media channels including Twitter, Facebook, Instagram and Linked In or read our blogs!

The Signs & Symptoms Of Bladder Cancer

Bladder Cancer Statistics

Bladder cancer is the 7th most common cancer here in the UK, with over 10,000 brits diagnosed annually. In general, it is a lot more likely to occur with age, as people aged 75 and above make up more than half of all new cases. Bladder cancer also tends to be more common in men than it is in women.

While the exact reason for this isn’t clear, it is thought that it’s perhaps because men were more likely to be exposed to harmful substances in the past due to their involvement in the manufacturing industry and the likelihood of cigarette use. Over time, exposure to harmful substances can lead to abnormal changes to the cells in your bladder, consequently causing cancer in some cases. Regardless of why or how bladder cancer occurs, it’s important to know what to look out for in terms of symptoms of bladder cancer so that you can recognise the condition early and seek appropriate treatment.

Blood In Your Urine

As a general rule, blood should never be ignored. You wouldn’t usually ignore blood, so why would you ignore blood in your urine? This is the most common symptom of bladder cancer and usually doesn’t cause any form of pain or discomfort.

Don’t disregard it as a one-off. Blood in your urine, professionally known as haematuria, can come and go, but you should always consult with your GP to determine the cause, even if it’s only happened the once. In some cases blood in urine might not be visible (but still be present); this is called micro haematuria and your GP is best equipped to determine whether is present or not.

Changes When Urinating

Less common symptoms include the sudden urge to urinate or the need to urinate more frequently, and also if there tends to be pain when passing urine.

More Advanced Symptoms Of Bladder Cancer

If bladder cancer isn’t caught in its early stages, there’s a chance that it might spread or develop into a more advanced stage. At this point, you might experience sudden weight loss, swelling of the legs, as well as pelvic and bone pain.

Of course, none of these symptoms automatically indicate the presence of bladder cancer until the cause has been officially determined, but you should always seek help and advice from your GP regardless. The earlier cancer is diagnosed, the higher your chance of survival. Most patients survive bladder cancer so long as it hasn’t spread or advanced to muscle-invasive cancer.

This is why our work at Arquer Diagnostics is so important. We are passionate about providing a safe and fast bladder cancer diagnostic test in the form of our new product, ADXBLADDER, so that more cases are diagnosed early and accurately, allowing for quicker treatment and a higher chance of survival. For more information on symptoms of bladder cancer and anything else including our new product, click here or contact us here.

Paving The Way For ADXBLADDER

Arquer Diagnostics

Each year in Europe, there are over 150,000 bladder cancer diagnoses, but up to a staggering 30% of these cancers are missed at the initial cystoscopy. While this costly test is currently considered the gold-standard, this level of accuracy is clearly suboptimal, not to mention the discomfort caused for the patient due to its invasive nature.

At 65%, bladder cancer has the highest recurrence rate of any malignancy, which is why the need for accurate diagnostic testing is so great. The challenges we face in bladder cancer diagnosis are what has led to the development of ADXBLADDER here at Arquer Diagnostics.

ADXBLADDER – A non-invasive bladder cancer test

Using our knowledge of MCM proteins as excellent cancer biomarkers, we wanted to develop an accurate, non-invasive bladder cancer test. The presence of MCM proteins in places where they should not be found (i.e. epithelium, lining of bladder, prostate etc,) is indicative of cancer. For example, if found within semen, it is likely that prostate cancer is present.

Similarly, if found within urine, it is likely that bladder cancer is present. ADXBLADDER is a fast and easy to use urine enzyme-linked immunosorbent assay (ELISA) based test that has been proven to accurately diagnose bladder cancer. This is a more comfortable, cost-effective and accurate alternative to a traditional cystoscopy.

Earlier this year, we announced the formation of two international medical advisory boards, consisting of internationally recognised senior urologists. The purpose of these boards was to support and advise Arquer Diagnostics throughout its research programme, including the preparation and implementation of our clinical studies. This was an important and necessary step for us to be able to validate our clinical strategy and development programmes so as to ensure our products would be both safe and accurate, having been brought to the market through the most rigorous processes.

ADXBLADDER launches in October 2017

All of this has taken us to where we are now, just days away from the official launch of ADXBLADDER at SIU 2017 in Lisbon on October 21st. This is a very exciting time for us and we can’t wait to debut our groundbreaking new product to the world during our live broadcast studio session, “A Breakthrough In Non-Invasive Bladder Cancer Diagnosis.” The impact that ADXBLADDER is expected to have on clinical practice is unprecedented, and we’re proud to continue fighting cancer on from the front line, with more exciting products to come in the near future!

To find out more about ADXBLADDER ahead of our launch in October, please don’t hesitate to get in touch.

Arquer Diagnostics announces CE Mark for its breakthrough bladder cancer test ADXBLADDER

Arquer Diagnostics Ltd (“Arquer”), an in-vitro diagnostic company, developing breakthrough diagnostic tests for the detection of bladder and prostate cancer, announced today the CE Mark approval on the company’s breakthrough bladder cancer test, ADXBLADDER.

ADXBLADDER

ADXBLADDER is a simple and reliable ELISA test that can detect MCM5 protein in urine: clinical studies have demonstrated that presence of MCM5 in urine is a clear indication of bladder cancer and that Arquer’s technology can reliably and consistently identify that. The latest clinical study, conducted on an (“all comers”) heterogenous population of 575 hematuria patients reported a 97% NPV value and an unprecedented 95% sensitivity in high risk cancers.

Nadia Whittley CEO of Arquer: “We are extremely excited about the ADXBLADDER launch: by fulfilling our mission (delivering accurate, rapid, minimally invasive oncology diagnostic products) we are now able to offer to bladder cancer patients and urologists a new and dramatically better diagnostic tool which will definitively have a positive impact on outcomes. Our efforts now are focused on continuing to produce new, strong and consistent clinical data to support the adoption of ADXBLADDER as we know there is a gap in the patient’s diagnostic pathway that need to be filled. A huge thank you is due to our Medical Advisory Board and all the centres participating in our clinical studies for guiding our clinical efforts and supporting the development of this novel diagnostic test. We are now moving into commercial phase in Europe and engaging with FDA with the objective of bringing this product to USA in the near future.”

ADXBLADDER is currently commercialised in UK, France, Italy, Turkey and the Nordic region through a highly qualified commercial network (see www.arquerdx.com for details); the product will be released to all other European countries as well as other regions worldwide throughout 2018. ADXBLADDER is not currently available in USA.

About Arquer Diagnostics

Arquer Diagnostics headquartered in Sunderland, United Kingdom, is a company focused on the development of non-invasive cancer diagnostic tests, based on the MCM5 (minichromosome maintenance protein) platform. Arquer Ltd was launched in 2015, following a strategic decision to put into action the powerful research that had been conducted by a small enterprise, founded in 2005 by Nick Miller-Jones (UroSens).

Since then, the company has amassed strong clinical data to support the launch of its first product ADXBLADDER, a bladder cancer diagnostic test, and is running a number of clinical trials to validate many other indications. Arquer is supported by first class international Medical Advisory Boards and together we are aiming at inspiring transformational change in the field of oncology diagnostics.

Click here to contact us.

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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Arquer Diagnostics completes patient recruitment for MCM5 clinical trial

  • 801 patients recruited for international clinical study to evaluate Arquer’s ELISA-based urine test for bladder cancer
  • Study results will serve to submit for CE marking

Sunderland, UK, 13th March 2017: Arquer Diagnostics Ltd (Arquer), a diagnostic company which has developed a high sensitivity, high specificity, ELISA-based urine test for bladder cancer, today announced that it has completed the recruitment of 801 patients for a clinical trial to evaluate the Company’s MCM5 bladder cancer diagnostic.

The results from the study will be used as part of the Company’s application for CE mark approval, ahead of the commercial launch of the MCM5 ELISA for Bladder Cancer, which is planned for Q3 2017. The study is expected to confirm the results obtained in a recent feasibility study, which indicated that the MCM5 ELISA performs well above other non-invasive diagnostic tests currently utilised in the routine diagnosis of bladder cancer, in terms of both specificity and sensitivity.

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Arquer Diagnostics awarded funding under Innovate UK’s Biocatalyst programme

Funding will be used to prepare for international clinical study to evaluate the Company’s ELISA-based urine test for prostate cancer

Sunderland, UK, 1st March 2017: Arquer Diagnostics Ltd (Arquer), a diagnostic company which has developed a high sensitivity, high specificity, ELISA-based urine test for bladder cancer, today announced that it has been awarded £70,000 funding under Innovate UK’s Biocatalyst programme, to be awarded over a 12 month period, starting 1st March 2017. The funding will be used to support preparations for an international clinical study to evaluate Arquer’s MCM5 ELISA-based non-invasive test for prostate cancer, as the Company expands the application of its technology into a wider range of cancers.

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Arquer Diagnostics Appoints Nadia Whittley as CEO

Sunderland, UK, 1st December 2016: Arquer Diagnostics Ltd (Arquer), a diagnostic company which has developed a high sensitivity, high specificity, ELISA-based urine test for cancer, today announced that it has appointed Nadia Whittley as CEO with immediate effect. With significant experience in strategy, sales and marketing, organisational effectiveness, M&A and fundraising in the small and mid-cap sectors, Nadia’s focus at Arquer will be to execute the commercial launch of the Company’s MCM5-ELISA diagnostic test, and expansion of the technology into a wider range of cancers.
With over 25 years’ experience in the life science sector, Nadia Whittley has an outstanding leadership record of growing revenues and motivating teams spanning several therapeutic areas and across different geographies, including EMEA, Asia Pacific and North America. Most recently Nadia was Partner and Managing Director, Europe, of Tefen Management Consulting, where she was responsible for the design and implementation of a 5-year strategic plan and development of the Life Science Business Unit in EMEA. Previously Nadia was CEO at Alium Medical Ltd, Managing Director Medical Devices EAME at Allergan Inc., Marketing Director EMEA in Interventional Cardiology at Boston Scientific International, and a non-executive Board member at Peptonic Medical AB.

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Arquer Diagnostics and the University of Sunderland collaborate to extend application of cancer diagnostic

Partnership will investigate non-invasive specimen preparation techniques for Arquer’s MCM5-ELISA test in a wider range of cancers

Sunderland, UK, 17 October 2016: Arquer Diagnostics Ltd (Arquer), a diagnostic company which has developed a high sensitivity, high specificity, ELISA-based urine test for cancer, today announced that it has signed a collaboration agreement with the University of Sunderland. The partnership aims to investigate non-invasive specimen preparation techniques, which will facilitate the use of Arquer’s MCM5-ELISA test in a wider range of cancers.
Arquer’s MCM5-ELISA is a simple, non-invasive test, which has been developed to accurately diagnose both bladder and prostate cancer. The test works by detecting the presence of minichromosome maintenance complex component 5 (MCM5) protein, a marker for the presence of dividing cancer cells, in urine. MCM proteins are directly involved in cell replication, and are shed into urine by both prostate and bladder tumours. Through the partnership with the University of Sunderland, Faculty of Applied Sciences, Arquer aims to identify the optimal conditions for processing various samples collected using different collection methods to assist in the preparation of a clinical feasibility study in a wider range of cancers.
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