The number of 2WW referrals in England has increased from 1 million per year at its inception in 2010 to more than 2.5 million in 2020, yet only 7% of referrals are ultimately diagnosed with cancer. The remaining 93% of patients are eventually given the all clear, but go through anxious waits for appointments and tests while pressure on the system slowly builds.

As if this weren’t enough, the consequences of the COVID-19 pandemic to cancer services have laid bare the urgent need for innovation. To protect NHS services and patients alike, we need a way to identify those patients at highest risk quickly to avoid stage-shift, and streamline cancer pathways to prevent unnecessary visits to hospital for those in vulnerable groups or simply at negligible risk.

To make further improvements in early cancer detection without overwhelming cancer diagnostic services, we will need new and powerful tools for clinical decision support. The PinPoint Test is just such a technology.

The test includes full blood counts, urea & electrolytes, liver function tests and a range of other markers all routinely available in NHS laboratories (33 data points in total). The same panel is used for all nine 2WW pathways for which use of the PinPoint Test is regulated, but the algorithm weights the information differently depending on the chosen referral pathway.

The PinPoint Test is integrated entirely within existing NHS infrastructure and firewalls for data security. No new or additional equipment is needed in labs and no identifiable patient information is shared outside of the normal channels.

The Test requires a single draw of blood. These bloods are processed in the normal way at an NHS pathology laboratory. 33 data points are measured, including the patient’s age and sex, and processed by PinPoint software running on an NHS IT system. A result is generated immediately and returned to the clinician, providing the probability that the patient has cancer (defined as a malignant or in situ neoplasm).

The PinPoint Test provides an extra level of insight on a patient’s risk profile for cancer, previously unavailable at the very early stages of clinical engagement. The result is intended to give clinicians more accurate information for consideration when deciding the best course of action for their patients.

For patients at higher risk of cancer, this can mean a more rapid onward journey through the urgent referral pathway. For patients at very low risk, this might mean they can avoid unnecessary diagnostic testing altogether, in favour of alternative routes of investigation with their GP.

It is anticipated that as many as 20% of current referrals in England will be eligible to be ruled out of the 2WW this way. The result will be reduced pressure on capacity for a more streamlined service, able to accommodate patients more quickly at every step and improve early cancer detection rates.

Yes. The PinPoint Test will be used alongside standard testing for suspected cancer. It is intended to provide an additional source of information to support clinicians in decision making around triage and prioritisation.

The PinPoint Test will be processed in NHS laboratories using standard equipment from any of the major providers. In North Yorkshire, the test will be processed at York and Scarborough Teaching Hospitals NHS Foundation Trust laboratories.

The PinPoint software was developed using a retrospective analysis of 371,799 2WW patients in the Leeds region between 2011-2019. This comprised of development and validation sets of 224,669 and 147,130 patients respectively.

The algorithm has been created by applying a combination of statistical and machine learning techniques to the data, specifically logistic regression and gradient boosting.

PinPoint Data Science and their collaborators from the NHS and University of Leeds have been  published in BMJ Open, with a peer-reviewed paper entitled:

‘Development and validation of multivariable machine learning algorithms to predict risk of cancer in symptomatic patients referred urgently from primary care: a diagnostic accuracy study.’

The paper can be found here.

Further papers on the health economics and potential impact of the PinPoint Test on waiting times and NHS clinic capacity for cancer diagnostics are currently in preparation. Prospective evaluation results in a real-world NHS setting will be published as they become available from the current NHS service evaluation.

The Test is currently being evaluated by the NHS in the West Yorkshire and Harrogate region. The West Yorkshire and Harrogate Cancer Alliance service evaluation covers the 9 referral pathways for which the PinPoint Test is already regulated for use.

The current phase is an observational service evaluation where test results are not used to inform clinical decisions. The evaluation is designed to confirm the performance of the test in a real world setting and to establish the logistics of running this new test in the NHS.

The planned second phase is a full clinical service rollout, whereby the test will be made available for use in clinical decision making. Preparation for this phase has already begun with support from NHS England & Improvement, and a grant from SBRI Healthcare to put in place the systems necessary for quality assurance and integration across the NHS.

This is complemented by a research project, funded by the Humber and North Yorkshire Cancer Alliance, which is investigating the potential of the PinPoint Test for serious non-site specific (SNSS) pathways.