What is Cytosponge?

CytospongePresently, oesophageal cancer is typically detected very late and has a low survival rate (13%). Scientists at the MRC Cancer Unit, University of Cambridge have developed a device called Cytosponge, a simple alternative to endoscopy, to facilitate the earlier detection of Barrett’s oesophagus, a precursor to oesophageal cancer. Coupled with laboratory assays, Cytosponge has the potential to diagnose and risk stratify (personalise) Barrett’s as a more cost-effective alternative to endoscopy.

Cytosponge and the associated assays have been licensed by the MRC to Covidien GI Solutions, which was later acquired by Medtronic, a large medical device company headquartered in Dublin. A pivotal trial (BEST3) will commence in early 2017, which plans to provide the required clinical evidence for Cytosponge to be adopted into NHS clinical pathways, with a view to confirming that it can be used as a viable, cheaper alternative to endoscopy.

Barriers to adoption and PMC capabilities

The main barriers to the adoption of Cytospongeinto the NHS are:

  • Data from a randomised trial designed to show the superiority of Cytosponge in diagnosing Barrett’s compared with standard clinical practice
  • Further data on acceptability to health care professionals and patients in the primary care setting
  • A detailed health economic analysis to support reimbursement

PMC will support GP uptake for the BEST3 trial, and assist with enabling regulatory and clinical adoption requirements. This will be achieved through a combination of direct support and connecting the stakeholders to the appropriate channels of assistance, e.g. MHRA and NICE.

Project plan, timeline and resourcing

The project plan will be completed ahead of the commencement of the BEST3 trial, followed by assistance with completion of the other aforementioned aspects, in order that Cytosponge is ready to be adopted into clinical practice following completion of the BEST3 trial. A consultant from PMC will be required to oversee project delivery, primarily concerning establishment of the regulatory and reimbursement pathways to enable adoption of Cytosponge into clinical practice.

Potential economic benefit and financial impact

A higher proportion of the population will be identified as ‘at risk’ of developing oesophageal cancer (through identification of Barrett’s oesophagus). Through earlier detection, the cost of treating oesophageal cancer could be reduced, and furthermore, due to earlier detection and increased diagnosis, there will be a reduced burden through treatment at an earlier stage of progression.
This is also a great opportunity to create a framework for companion diagnostics, a key area of precision medicine which is relatively under established in Europe (compared to other medical devices), and also to encourage more frequent and widespread testing for oesophageal pre-cancer.

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