Our Vision is inspiring transformational change in the field of oncology diagnostics

ARQUERDIAGNOSTICS

Arquer Diagnostics is a UK based company that is developing a game-changing platform for a range of fast, non-invasive tests for diagnosing and monitoring cancer.

Our platform uses a patented technology built upon 20 years of research, to detect the presence of a protein produced by the expression of the MCM5 (Minichromosome Maintenance Complex Component 5) gene.

ADXBLADDERTM

ADXBLADDER is the first of Arquer’s MCM5 tests to launch.

It is a CE marked in vitro diagnostic (CE IVD) bladder cancer test that can reduce the need for patients to undergo unnecessary, invasive and often painful testing, while helping to speed up the diagnosis of those at highest risk of having the disease.

Rigorous clinical trials involving approximately 3,000 patients show unequivocally that this innovative, non-invasive test is quicker and more accurate than the current standard diagnostic journey.

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

MCM5 – A Research Breakthrough

Play Video
  • 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: 10.1073/pnas.95.25.14932

Pipeline indications for other cancers

Arquer’s technology platform is also showing positive early data in the diagnosis of prostate and endometrial cancers and similar products are undergoing clinical validations in these indications.

Our first study in endometrial cancer with ADXGYNAETM has recently been published.

“The very encouraging results of the first study are a great starting point for the clinical program we are engaging in. Should the results be confirmed, women will be able to access a new minimally invasive test for endometrial cancer diagnosis, decreasing the need for unnecessary invasive procedures”

ASSOCIATE PROFESSOR OLAWAIYEA
WOMEN’S HOSPITAL OF THE UNIVERSITY OF PITTSBURGH MEDICAL CENTER

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

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.