News and Events

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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Arquer Diagnostics Appoints Louise Flintoft as Product Manager

Appointment strengthens senior team in preparation for EU regulatory approval and commercial launch of Mcm5-ELISA test

Sunderland, UK, 13 July 2016: Arquer Diagnostics Ltd (Arquer), a diagnostic company which has developed a high sensitivity, high specificity, ELISA-based urine test for cancer, today announced the appointment of Louise Flintoft to the post of Product Manager. Louise’s appointment serves to strengthen Arquer’s commercial team in preparation for EU regulatory approval and commercial launch of its Mcm5-ELISA test. Louise will take responsibility for all aspects of product marketing, commercial management and distribution, as well as being a key contributor to future product development and commercialisation.
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Arquer Diagnostics signs Manufacturing and Supply Agreement with Euro Diagnostica

Sunderland, UK, 08 February 2016: Arquer Diagnostics Ltd (Arquer), a diagnostic company which has developed a high sensitivity, high specificity, ELISA-based urine test for cancer, has announced that it has signed an agreement with Euro Diagnostica AB (Euro Diagnostica) for the manufacturing and supply of Arquer’s Mcm5-ELISA test for the diagnosis of bladder cancer. Under the terms of the agreement, Arquer intends to use Euro Diagnostica as its primary manufacturer of its Mcm5-ELISA test kits.

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Arquer Diagnostics Receives Ethical Approval for Largest Privately Funded Bladder Cancer Study in UK

  • Arquer’s high sensitivity, ELISA test in study for Bladder Cancer
  • Six month, multi-centre 800 patient clinical trial
  • Study builds on successful 350 patient Bladder Cancer trial

Sunderland, UK, 11 January 2016: Arquer Diagnostics Ltd (Arquer), a diagnostic company which has developed a high sensitivity, high specificity, ELISA-based urine test for cancer, has announced that it has received ethical approval to commence a six month clinical study. This is awarded by a Health Research Authority Research Ethics Committee (REC) and is the approval of the project’s Protocol. The new study will provide the data necessary for regulatory approval and registration of the company’s Mcm5-ELISA test for the diagnosis of bladder cancer.

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Arquer Diagnostics Announces Clinical Study for Recurrent Bladder Cancer

  • High Sensitivity, ELISA test in study for Bladder Cancer recurrence
  • Six month, investigator-led study at Southampton University
  • Study builds on successful 350 patient Bladder Cancer trial

Sunderland, UK, 7th December 2015: Arquer Diagnostics Ltd (Arquer), a diagnostic company which has developed a high sensitivity, high specificity, ELISA-based urine test for cancer, has announced the start of a six month clinical study to optimise the effectiveness of the company’s Mcm5-ELISA test for the diagnosis of recurrent bladder cancer. The study will be led by Tim Dudderidge MB ChB MSc FRCS (Urol) at the Southampton General Hospital and follows on from the recent successful screening trial involving 350 haematuria patients, which indicated the Mcm5-ELISA test has a Sensitivity of 83% Specificity of 77% and Negative Predictive Value of 98%.
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UroSens Announces Corporate Name Change and Rebranding to Arquer Diagnostics Ltd

Rebranding reflects Company’s expansion into new oncology areas

Sunderland and Cambridge, UK, 20 July 2015: UroSens Ltd, a diagnostic company developing novel, non-invasive urine-based immunoassay tests for the detection of cancer, has announced it has changed its name to Arquer Diagnostics Ltd (Arquer). As part of the name change, the Company has undergone a total brand refresh, which will see the implementation of a new visual identity and online presence to support Arquer’s future plans, evolution and growth, with immediate effect. To coincide with the rebranding, Arquer has launched a redesigned website www.arquerdx.com/
The rebranding reflects the progression of the Company’s strategic focus, beyond prostate and bladder cancer into diagnostics for multiple cancers of the urinogenitary tract, including colorectal and cervical cancers.

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