FIT Screening - UK - Royal Preston Hospital Adopts the OC-Sensor™ Faecal Immunochemical Test

Dr Martin Myers, Consultant Clinical Scientist and Laboratory Director of Clinical Biochemistry at Lancashire Teaching Hospitals NHS Foundation Trust and Dr Natalie Hunt, Principal Clinical Biochemist discuss the introduction of the OC Sensor FIT technology into the Royal Preston Hospital.

Where did you first hear about the OC-Sensor FIT?

Dr Martin Myers: We read about FIT in the NICE guidelines. We stopped the faecal occult blood test (FOBT) here about 5 to 8 years ago. We liked the principal of an occult blood test but rejected the old assay as we felt that it was not very specific. When FIT was introduced, we believed that we had found an assay that would produce the accurate results that we were looking for.

Dr Natalie Hunt: The representative from MAST^® visited the laboratory to introduce us to the OC-Sensor FIT product. 

What prompted you to explore the adoption of the OC-Sensor FIT?

Dr Natalie Hunt: Most of the research papers and studies that I have read use it; worldwide it is the most popular FIT assay and we decided to implement a trial. We did a parallel study sending patients two collection devices, one sample was sent to a reference lab and the other tested here at the Royal Preston on the OC-Sensor for comparison. It was on the basis of this study that we decided to adopt the use of the OC-Sensor. When we verified the OC-Sensor in the laboratory, we got very good results. It is easy to use and the clinical outcomes are a major plus point.

Dr Martin Myers: We were interested in the test and were fortunate to be supported by General Practitioners in the area through our GP liaison group where we meet to discuss current and future practice. There are always a number of ways to go live with a test: we can push it forward onto our clinicians, recommending it as best practice, or sometimes the clinicians will come to us and ask for a certain test. The beauty of FIT is that the driver for adoption came from both directions; it was our CCG that asked we implement it in the end. Initially the reference lab were able to support us with testing while we introduced the OC-Sensor here at the Royal Preston. We liked the new assay as scientists and GPs embrace decision diagnostics to inform them as to which care pathways to put their patients on, which the FIT provides.

How did you escalate this further and what challenges did you face?

Dr Martin Myers: We always have to discuss certain requirements as it is a new test. However in terms of clinical obstacles, none were presented from the team that wrote the local cancer guidelines and the GP practices just wanted assurance from ourselves that the test was of acceptable quality. There was no real opposition to introducing the OC-Sensor, everybody wanted it. 

How many tests are you doing now?

Dr Martin Myers: The Royal Preston has just gone live with the OC-Sensor. We started with about 20 faecal immunochemical tests per week and we are seeing the numbers of tests referred to the department increase from hospitals outside of the Trust.

What stakeholders were involved in the adoption of FIT and how do you engage with them?

Dr Martin Myers: We are about to publish a FIT information sheet for GPs so we are expecting the uptake from them to increase significantly. We also have a series of aligned meetings planned with endoscopists, GP lead cancer clinicians and oncology surgeons as part of the multi stakeholder strategy we are adopting to ensure that the assay meets the requirements of all the interested parties. Because it is a clinical diagnostic we have to get the clinicians on board. We have received positive feedback from them to date. The last part of the jigsaw is the endoscopy department as the FIT should reduce the pressure on them. There are some interesting studies being undertaken currently looking at patients completing a faecal immunochemical test while waiting for an endoscopic procedure. Dependent on the results of the test this would speed up their position in the queue.

Dr Natalie Hunt: We have also involved other stakeholders in the care pathway, such as gastroenterology, who have seen the guidelines and are keen to use faecal immunochemical testing to triage patients and use resource on the most appropriate people. The clinical biochemistry laboratory at the Royal Preston Hospital has a protocol to repeat any negative results obtained from a faecal immunochemical test. This provides reassurance for surgical colleagues working in the colorectal and oncology departments providing an additional safety net. The department also collects the audit data on these clinical outcomes for future reference.

How did you go about implementing the service?

Dr Martin Myers: We spoke to all the individual groups of stakeholders and it has all been very positive. One reason is that the OC-Sensor FIT provides a biomarker that will make an economic difference to the patient pathway. Clinicians and healthcare practitioners at the Trust are now examining the health economics of the pathway: One FIT test is far cheaper than an endoscopic procedure. In nearly every pathway in the NHS, the pathology cost is probably the smallest by far. By utilising new technologies in pathology, we can drive down costs in other areas. This is exactly what the FIT allows us to do.

What improvements has FIT delivered in the care pathway?

Dr Natalie Hunt: The long shelf life of the OC-Sensor enables stocks of sample collection devices to be retained by both the Trust and GP practices, which eliminates the need to call the laboratories to request the test. The result is better and faster logistics - from a patient being asked to provide a sample to getting the results back from the laboratory to the GP.

Dr Martin Myers: This is one of the main practical improvements from the previous system. The improved logistics makes the processing of the samples and hence obtaining the results far quicker and more streamlined. The decision process is speeded up which provides reassurance to the patient and a clear care pathway objective for the clinicians treating the patient.

What are the outcomes of implementing FIT?

Dr Martin Myers: We went online with the test here in June. It is early days for us in terms of assessing patient outcomes, however, we are very aware of the increasing pressure on the endoscopy department and we are keen to assess the role of FIT in triaging patients in secondary care. We believe the number of endoscopy procedures requested will decrease due to the introduction of the faecal immunochemical test. The result of this will be that more appropriate patients will be seen faster by the endoscopy department. In turn, these patients will have a shorter wait for their results and those people in need of further treatment will be seen faster. 

Ms Susan Wareing, Lead Biomedical Scientist Clinical Biochemistry and Carol Wignall, Senior Biomedical Scientist at The Royal Preston Hospital discussed the introduction of the OC-Sensor to the laboratory.

What has your experience been with the OC Sensor products?

Susan Wareing / Carol Wignall: We have seen the value of the faecal immunochemical test. Everyone has picked up the test very easily. OC-Sensor is very easy to use with minimal maintenance. We are currently processing one run a week at the moment but this is expected to increase. We have sent out 600 sample collection devices to GPs so the long shelf life of the product is a huge advantage.

What are your thoughts about the use of the OC-Sensor and FIT for the future?

Operationally the OC-Sensor is great, the collection device is great and the use of the machine is great. We are becoming a reference site for FIT because we have the expertise and people have the confidence not only in the reputation of the department but also in the science behind it. A huge amount of verification goes on at Preston, getting through the filter here is a very high bar to cross.

We know that we have confidence in the OC-Sensor for this reason. My main question is: Is what we have now better than what we had before? The answer is yes.