Cytosystems’ core technologies are based on utilising mini-chromosome maintenance (MCM) antibodies in a liquid-based cytology (LBC) platform. Clinical researchers at the University of Cambridge first identified the association of the proliferative MCM biomarker with cancer in the 1990s, and MCM biomarker technology has subsequently been proven to be highly sensitive and specific for the detection of a variety of cancers - lung, kidney, skin, cervical, colon, ovarian, breast, bladder, prostate, and so on. Our whole-cell approach provides added accuracy by reducing false positives that would be generated through a molecular-only approach.
For some years, urologists and cytopathologists have recognised the theoretical benefits of simple, inexpensive and reliable urine tests for the diagnosis of bladder cancers. The major challenges to date in developing MCM biomarker technology have been the ability to deliver superior sensitivity and specificity performance over conventional cytology, and to enable improved clinical practice without disruption.
Cytosystems’ founder Dr David Galloway, previously director of the clinical trials unit in Aberdeen Royal Infirmary, recognised the potential of MCM biomarker technology to deliver simple, reliable and inexpensive diagnostic technologies for bladder and prostate cancer in particular.
This significant discovery marked the transition from bench research to a clinical product and directly led to the establishment of Cytosystems.
Cytosystems bases its development of cancer diagnostic technologies on data generated from over 1,000 clinical samples obtained to date from patients in five different locations across the UK. Based on the extremely positive results of an ISO13485-regulated trial, even in detecting lower grade cancers, Cytosystems is now progressing to a large scale multi-centre clinical trial.
In June 2015, Cytosystems was awarded funding of over €3million; this project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No673664. This award is underpinning the completion of a Phase 2 multi-centred clinical trial and the early securing of UK MHRA (Medicines and Healthcare Products Regulatory Agency) and US FDA (Food and Drug Administration) approval. In August 2015, Cytosystems was further awarded funding from Innovate UK, the UK's innovation agency, which will enable further research into cell processing with potential for further applications.
Cytosystems’ first proprietary product, BladderLight™, is a highly sensitive and specific urine-based assay which improves both the diagnosis of bladder cancer and the ongoing management of patients.
Cytosystems is currently aiming to develop complementary point of care products to further improve the treatment of bladder and prostate cancer patients.
Richard Berry, an experienced business leader, has been CEO of Cytosystems since 2007 and has overseen the recruitment of the development team, the implementation of successful first- and second-phase clinical trials and the securing of grant and investment funding. Among the major private investors in the company is Jamie Oag, a highly successful Scottish technology entrepreneur with wide-ranging business interests.