Our Vision is to inspire transformational change in the field of oncology diagnostics

Transforming the Future of Cancer Diagnosis

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

The Cancer Biomarker Technology Behind Our Innovative Tests

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  • Kelly JD, Dudderidge TJ, Wollenschlaeger A, Okoturo O, Burling K, Tulloch F, Halsall I, Prevost T, Prevost AT, Vasconcelos JC, Robson W, Leung HY, Vasdev N, Pickard RS, Williams GH, Stoeber K. Bladder cancer diagnosis and identification of clinically significant disease by combined urinary detection of Mcm5 and nuclear matrix protein 22. PLoS One. 2012;7(7):e40305. Epub 2012 Jul 9. PMID: 22792272; PMCID: PMC3392249. Link: 10.1371/journal.pone.0040305

  • Dudderidge TJ, Kelly JD, Wollenschlaeger A, Okoturo O, Prevost T, Robson W, Leung HY, Williams GH, Stoeber K. Diagnosis of prostate cancer by detection of minichromosome maintenance 5 protein in urine sediments. Br J Cancer. 2010 Aug 24;103(5):701-7. PMID: 20648010; PMCID: PMC2938246. Link: 10.1038/sj.bjc.6605785

  • Ayaru L, Stoeber K, Webster GJ, Hatfield AR, Wollenschlaeger A, Okoturo O, Rashid M, Williams G, Pereira SP. Diagnosis of pancreaticobiliary malignancy by detection of minichromosome maintenance protein 5 in bile aspirates. Br J Cancer. 2008 May 6;98(9):1548-54. Epub 2008 Apr 15. PMID: 18414413; PMCID: PMC2391096. Link: 10.1038/sj.bjc.6604342

  • Williams GH, Swinn R, Prevost AT, De Clive-Lowe P, Halsall I, Going JJ, Hales CN, Stoeber K, Middleton SJ. Diagnosis of oesophageal cancer by detection of minichromosome maintenance 5 protein in gastric aspirates. Br J Cancer. 2004 Aug 16;91(4):714-9. PMID: 15266314; PMCID: PMC2364793. Link: 10.1038/sj.bjc.6602028

  • Stoeber K, Swinn R, Prevost AT, de Clive-Lowe P, Halsall I, Dilworth SM, Marr J, Turner WH, Bullock N, Doble A, Hales CN, Williams GH. Diagnosis of genito-urinary tract cancer by detection of minichromosome maintenance 5 protein in urine sediments. J Natl Cancer Inst. 2002 Jul 17;94(14):1071-9. PMID: 12122098. Link: 10.1093/jnci/94.14.1071

  • Going JJ, Keith WN, Neilson L, Stoeber K, Stuart RC, Williams GH. Aberrant expression of minichromosome maintenance proteins 2 and 5, and Ki-67 in dysplastic squamous oesophageal epithelium and Barrett’s mucosa. Gut. 2002 Mar;50(3):373-7. PMID: 11839717; PMCID: PMC1773132. Link: 10.1136/gut.50.3.373

  • Stoeber K, Halsall I, Freeman A, Swinn R, Doble A, Morris L, Coleman N, Bullock N, Laskey RA, Hales CN, Williams GH. Immunoassay for urothelial cancers that detects DNA replication protein Mcm5 in urine. Lancet. 1999 Oct 30;354(9189):1524-5. PMID: 10551502. Link: 10.1016/S0140-6736(99)04265-8

  • Williams GH, Romanowski P, Morris L, Madine M, Mills AD, Stoeber K, Marr J, Laskey RA, Coleman N. Improved cervical smear assessment using antibodies against proteins that regulate DNA replication. Proc Natl Acad Sci U S A. 1998 Dec 8;95(25):14932-7. PMID: 9843993; PMCID: PMC24553. Link: https://www.pnas.org/content/95/25/14932

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.

New Generation Bladder Cancer Diagnostics

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

Bladder image
These trials have also shown that ADXBLADDER enables urologists to confidently exclude the presence of the disease with a negative predictive value (NPV) of 99%, without having to use cytology, and potentially reducing the need for unnecessary and invasive cystoscopies.

  • Roupret M, Gontero P, McCracken SRC, Dudderidge T, Stockley J, Kennedy A, Rodriguez O, Sieverink C, Vanié F, Allasia M, Witjes JA, Colombel M, Sylvester R, Longo F, Montanari E, Palou J. Diagnostic Accuracy of MCM5 for the Detection of Recurrence in Nonmuscle Invasive Bladder Cancer Followup: A Blinded, Prospective Cohort, Multicenter European Study. J Urol. 2020 Oct;204(4):685-690. Epub 2020 Apr 21. PMID: 32314931. Link: 10.1097/JU.0000000000001084 

  • Gontero P, Montanari E, Roupret M, Longo F, Stockley J, Kennedy A, Rodriguez O, McCracken SRC, Dudderidge T, Sieverink C, Vanié F, Allasia M, Witjes JA, Sylvester R, Colombel M, Palou J. Comparison of the performances of the ADXBLADDER test and urinary cytology in the follow-up of non-muscle-invasive bladder cancer: a blinded prospective multicentric study. BJU Int. 2020 Aug 3. Epub ahead of print. PMID: 32745350. Link: 10.1111/bju.15194

  • Dudderidge T, Stockley J, Nabi G, Mom J, Umez-Eronini N, Hrouda D, Cresswell J, McCracken SRC. 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. 2020 Feb;3(1):42-46. Epub 2019 Jul 13. PMID: 31307961 Link: 10.1016/j.euo.2019.06.006

  • Anastasi E, Maggi M, Tartaglione S, Angeloni A, Gennarini G, Leoncini PP, Sperduti I, Di Lascio G, De Stefano V, Di Pierro GB, Del Giudice F, Busetto GM, De Berardinis E, Sciarra A. Predictive value of MCM5 (ADXBLADDER) analysis in urine of men evaluated for the initial diagnosis of bladder cancer: A comparative prospective study. Diagn Cytopathol. 2020 Jun 20. Epub ahead of print. PMID: 32562513. Link 10.1002/dc.24530

  • Białek Ł, Czerwińska K, Fus Ł, Krajewski W, Sadowska A, Radziszewski P, Dobruch J, Kryst P, Poletajew S. MCM5 urine expression (ADXBLADDER) is a reliable biomarker of high-risk non- muscle-invasive bladder cancer recurrence: A prospective matched case-control study. Cancer Biomark. 2020 Sep 4. Epub ahead of print. PMID: 32924986. Link 10.3233/CBM-200316

A Urine Test To Diagnose Endometrial Cancer

Endometrial cancer, which is also known as womb or uterine cancer, is a devastating disease and cases continue to rise – it is already the sixth most common cancer in women.6

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

Endometrial image
Stockley J, Akhand R, Kennedy A, Nyberg C, Crosbie EJ, Edmondson RJ. Detection of MCM5 as a novel non-invasive aid for the diagnosis of endometrial and ovarian tumours. BMC Cancer. 2020 Oct 15;20(1):1000. PMID: 33059604; PMCID: PMC7559715. Link: 10.1186/s12885-020-07468-y

ADXBLADDERTM is only available by request from a patient’s Urologist and can be ordered through our distribution partners.

For the UK: ​

NHS Urologists: To discuss how to get ADXBLADDER testing in a NHS Hospital, please contact ArquerDX directly on 0191 516 6765.

Private Urologists:
To order a test for a patient in your private practice please contact Synlab UK Ltd directly by emailing adxbladder@synlab.co.uk.
See our full list of distributors here.

[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

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.

MCM5 – The Biomarker Transforming Cancer Diagnosis

  • Kelly JD, Dudderidge TJ, Wollenschlaeger A, Okoturo O, Burling K, Tulloch F, Halsall I, Prevost T, Prevost AT, Vasconcelos JC, Robson W, Leung HY, Vasdev N, Pickard RS, Williams GH, Stoeber K. Bladder cancer diagnosis and identification of clinically significant disease by combined urinary detection of Mcm5 and nuclear matrix protein 22. PLoS One. 2012;7(7):e40305. Epub 2012 Jul 9. PMID: 22792272; PMCID: PMC3392249. Link: 10.1371/journal.pone.0040305

  • Dudderidge TJ, Kelly JD, Wollenschlaeger A, Okoturo O, Prevost T, Robson W, Leung HY, Williams GH, Stoeber K. Diagnosis of prostate cancer by detection of minichromosome maintenance 5 protein in urine sediments. Br J Cancer. 2010 Aug 24;103(5):701-7. PMID: 20648010; PMCID: PMC2938246. Link: 10.1038/sj.bjc.6605785

  • Ayaru L, Stoeber K, Webster GJ, Hatfield AR, Wollenschlaeger A, Okoturo O, Rashid M, Williams G, Pereira SP. Diagnosis of pancreaticobiliary malignancy by detection of minichromosome maintenance protein 5 in bile aspirates. Br J Cancer. 2008 May 6;98(9):1548-54. Epub 2008 Apr 15. PMID: 18414413; PMCID: PMC2391096. Link: 10.1038/sj.bjc.6604342

  • Williams GH, Swinn R, Prevost AT, De Clive-Lowe P, Halsall I, Going JJ, Hales CN, Stoeber K, Middleton SJ. Diagnosis of oesophageal cancer by detection of minichromosome maintenance 5 protein in gastric aspirates. Br J Cancer. 2004 Aug 16;91(4):714-9. PMID: 15266314; PMCID: PMC2364793. Link: 10.1038/sj.bjc.6602028

  • Stoeber K, Swinn R, Prevost AT, de Clive-Lowe P, Halsall I, Dilworth SM, Marr J, Turner WH, Bullock N, Doble A, Hales CN, Williams GH. Diagnosis of genito-urinary tract cancer by detection of minichromosome maintenance 5 protein in urine sediments. J Natl Cancer Inst. 2002 Jul 17;94(14):1071-9. PMID: 12122098. Link: 10.1093/jnci/94.14.1071

  • Going JJ, Keith WN, Neilson L, Stoeber K, Stuart RC, Williams GH. Aberrant expression of minichromosome maintenance proteins 2 and 5, and Ki-67 in dysplastic squamous oesophageal epithelium and Barrett’s mucosa. Gut. 2002 Mar;50(3):373-7. PMID: 11839717; PMCID: PMC1773132. Link: 10.1136/gut.50.3.373

  • Stoeber K, Halsall I, Freeman A, Swinn R, Doble A, Morris L, Coleman N, Bullock N, Laskey RA, Hales CN, Williams GH. Immunoassay for urothelial cancers that detects DNA replication protein Mcm5 in urine. Lancet. 1999 Oct 30;354(9189):1524-5. PMID: 10551502. Link: 10.1016/S0140-6736(99)04265-8

  • Williams GH, Romanowski P, Morris L, Madine M, Mills AD, Stoeber K, Marr J, Laskey RA, Coleman N. Improved cervical smear assessment using antibodies against proteins that regulate DNA replication. Proc Natl Acad Sci U S A. 1998 Dec 8;95(25):14932-7. PMID: 9843993; PMCID: PMC24553. Link: https://www.pnas.org/content/95/25/14932
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Distribution Partners

ADXBLADDERTM is only available by request from a patient’s Urologist and can be ordered through our distribution partners.
For the UK: ​

NHS Urologists: To discuss how to get ADXBLADDER testing in a NHS Hospital, please contact ArquerDX directly on 0191 516 6765.

Private Urologists:
To order a test for a patient in your private practice please contact Synlab UK Ltd directly by emailing adxbladder@synlab.co.uk.
See our full list of distributors here.

[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