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Cancer remains the leading cause of death worldwide, claiming the lives of nearly 10 million people each year1, more than any other disease or condition – a figure which is only expected to grow.
Early and accurate diagnosis is the single most effective way to improve cancer survival rates. This is often hindered by the availability and the cost of appropriate tests: today seven in 10 people are still subjected to invasive and often unnecessary procedures to get a diagnosis.
At Arquer Diagnostics, we are at the forefront of a revolution in cancer diagnosis, developing cost-effective, non-invasive tests which harness patented biomarker technology to diagnose and monitor cancers including bladder, endometrial, prostate and ovarian which together account for more than 2.7 million diagnoses globally each year.2
Our prototype MCM5 ELISA (enzyme-linked immunosorbent assay) Test was developed in collaboration with Cancer Research UK and can accurately detect abnormal levels of the cancer biomarker MCM5 (Minichromosome Maintenance Complex Component 5) in bodily fluids such as urine.
MCM5 has been the subject of extensive cancer research since its discovery at Cambridge University two decades ago. It plays an important role in normal cell division where its levels are well regulated. But its levels increase when cancer is present because cancer cells are continually dividing.
Detecting bladder cancer accurately is vital if we are to make a real impact on thousands of lives. When diagnosed at its earliest stage, more than 95% of people will survive for a year or more, compared with 36% of people diagnosed at the latest stage.3
Transformative advances in diagnostic technologies and cancer biomarker research have led to the development of our new generation, highly accurate cancer diagnostic tests. ADXBLADDERTM enables urologists to quickly determine those who may have cancer and need further investigation and those who don’t, drastically reducing the number of unnecessary procedures patients must undergo.
One of the most common signs of bladder cancer is blood in the urine – or haematuria – but up to 90% of those investigated for visible blood and 95% of those for non-visible blood did not have bladder cancer.4 Blood in the urine can be caused by a number of other conditions including a urinary tract infection or kidney disease.
Bladder cancer is currently the tenth most common cancer in the world and in 2020 claimed the lives in almost a quarter of a million people. Its toll is expected to continue to worsen with the number of new cases set to soar by almost three quarters by 2040 to almost a million people each year.2
We believe there is an urgent need for a non-invasive, painless, and highly accurate test to diagnose this disease. Initial studies have shown our ADXGYNAETM test – a semi-quantitative ELISA (enzyme-linked immunosorbent assay) – can rule out cancer with 99.2% accuracy from a simple urine sample in as little as three hours and ongoing studies are being carried out.5
Currently, the only way to diagnose endometrial cancer is for women to undergo a Transvaginal ultrasound (TVUS) and, if that reveals changes to the thickness of the lining of the womb, then a biopsy is carried out to remove a sample of cells for lab testing.
Because of this lack of diagnostic options, 12.2 million of these invasive and often painful tests are conducted globally each year, with just 3-5% resulting in a cancer diagnosis.7 With a rapid increase in cases predicted, the number of tests required is projected to be over 20 million a year by 2040.8
ADXBLADDERTM is only available by request from a patient’s Urologist and can be ordered through our distribution partners.
NHS Urologists: To discuss how to get ADXBLADDER testing in a NHS Hospital, please contact ArquerDX directly on 0191 516 6765.
[1] Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M, et al. Global Cancer Observatory: Cancer Today. Lyon: International Agency for Research on Cancer; 2020 (https://gco.iarc.fr/today, accessed February 2021).
[2] WHO Cancer Today Estimated number of new cases in 2020, worldwide, both sexes, all ages https://gco.iarc.fr/today/online-analysis-table?v=2020&mode=cancer&mode_population=continents&population=900&populations=900&key=asr&sex=0&cancer=39&type=0&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&group_cancer=1&include_nmsc=1&include_nmsc_other=1. Last accessed September 2021
[3] Office for National Statistics, Cancer survival by stage at diagnosis for England(link is external), 2019.
[4] NHS website: Symptoms https://www.nhs.uk/conditions/bladder-cancer/symptoms/ Last accessed September 2021
[5] 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/
[6] World Cancer Research Fund: Endometrial cancer statistics https://www.wcrf.org/dietandcancer/endometrial-cancer-statistics/ Last accessed September 2021
[7] Clarke et al Association of Endometrial Cancer Risk With Postmenopausal Bleeding in Women JAMA Intern Med. 2018 Sep; 178(9): 1210–1222
[8] WHO Cancer Today Estimated number of new cases from 2020 to 2040, Incidence, Both sexes, age [0-85+] https://gco.iarc.fr/tomorrow/en/dataviz/tables?cancers=24 Last accessed September 2021
ADXBLADDERTM is our highly accurate, non-invasive test which can detect the cancer biomarker MCM5 (Minichromosome Maintenance Complex Component 5) from a simple urine sample in just three hours.
Rigorous clinical trials of this MCM5 ELISA (enzyme-linked immunosorbent assay) test have been carried out in around 3,000 patients, showing it can rule out the presence of bladder cancer with a negative-predictive value (NPV) of 99% and it is already approved for use across EMEA.
The innovative test is also being evaluated in a bladder cancer recurrence monitoring study in the USA and, if the US Food and Drug Administration (FDA) gives it clearance to be commercialised, it would make ADXBLADDER the first, new generation urinary biomarker test for bladder cancer to be approved by the FDA in almost two decades.
MCM (Minichromosome Maintenance) protein biomarkers were first discovered more than 20 years ago at Cambridge University by cell biologist Professor Ron Laskey and cancer biologist Dr Kai Stoeber. Since then, they have been the subject of extensive cancer research.
MCM5 (Minichromosome Maintenance Complex Component 5) is a protein which plays an important role in normal cell division where levels are well regulated. Cancer cells are continually dividing which increases levels of MCM5 in the area where the cancer is situated.
In collaboration with Cancer Research UK, we developed our prototype MCM5 ELISA (enzyme-linked immunosorbent assay) Test which can accurately detect abnormal levels of MCM5 in bodily fluids such as urine. We have gone on to perfect and extensively test our patented technology at our Sunderland headquarters.
NHS Urologists: To discuss how to get ADXBLADDER testing in a NHS Hospital, please contact ArquerDX directly on 0191 516 6765.
[1] Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M, et al. Global Cancer Observatory: Cancer Today. Lyon: International Agency for Research on Cancer; 2020 (https://gco.iarc.fr/today, accessed February 2021).
[2] WHO Cancer Today Estimated number of new cases in 2020, worldwide, both sexes, all ages https://gco.iarc.fr/today/online-analysis-table?v=2020&mode=cancer&mode_population=continents&population=900&populations=900&key=asr&sex=0&cancer=39&type=0&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&group_cancer=1&include_nmsc=1&include_nmsc_other=1. Last accessed September 2021
[3] Office for National Statistics, Cancer survival by stage at diagnosis for England(link is external), 2019.
[4] NHS website: Symptoms https://www.nhs.uk/conditions/bladder-cancer/symptoms/ Last accessed September 2021
[5] 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/
[6] World Cancer Research Fund: Endometrial cancer statistics https://www.wcrf.org/dietandcancer/endometrial-cancer-statistics/ Last accessed September 2021
[7] Clarke et al Association of Endometrial Cancer Risk With Postmenopausal Bleeding in Women JAMA Intern Med. 2018 Sep; 178(9): 1210–1222
[8] WHO Cancer Today Estimated number of new cases from 2020 to 2040, Incidence, Both sexes, age [0-85+] https://gco.iarc.fr/tomorrow/en/dataviz/tables?cancers=24 Last accessed September 2021
