What is the PinPoint Test ?
The PinPoint Test is a completely new type of blood test designed to optimise NHS urgent cancer referral pathways, also known as the ‘two week wait’ (2WW). Developed using machine learning to analyse data from hundreds of thousands of patients, collected over a decade, the Test is able to produce a single number: the chance that a patient has cancer.
The test is a decision support tool to provide doctors with the information they need to more effectively triage patients when they first present with symptoms. By flagging patients at either end of the scale, the PinPoint Test will allow those at highest risk to be fast-tracked for investigation in Secondary Care, and those at minimal risk to be safely ruled out. For the majority that fall between these two extremes of risk, their clinical pathway will be unaffected.
To make the greatest impact where it is needed, the PinPoint Test is CE marked for the 9 most populous pathways, representing over 98% of all 2WW referrals: Breast, Gynaecological, Haematological, Head & Neck, Lower GI, Lung, Skin, Upper GI & Urological.
Deployed at scale, we believe the PinPoint Test can deliver faster diagnosis for cancer, reduced backlogs, improved patient welfare and significant cost savings to the NHS.
Why is there a need for the PinPoint Test ?
The number of 2WW referrals in England has increased from 1 million per year at its inception in 2010 to more than 2.8 million in 2022, yet only 7% of referrals are ultimately diagnosed with cancer. The remaining 93% of patients are eventually given the all clear, but go through expensive, time consuming and stressful diagnostic tests, affecting patient lives and using funds that could be used elsewhere.
On top of this, the effects of the COVID-19 pandemic on 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.
How will results be used ?
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.
Evidence and publications
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.
In November 2022, BMC published a peer-reviewed capacity modelling paper by the Health Economics team at the University of Leeds. The paper looks at the potential impact of the PinPoint Test on the Breast Clinic at Leeds Teaching Hospitals NHS Trust:
‘An exploratory assessment of the impact of a novel risk assessment test on breast cancer clinic waiting times and workflow: a discrete event simulation model’
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.
How does it work ?
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).
Will this test delay a patient’s 2WW referral ?
No. A GP will order the PinPoint Test when they refer their patient to the relevant 2WW pathway, so will not delay referral.
Can a clinician override a PinPoint Test result ?
Yes. The PinPoint Test is a decision support tool. It provides a calibrated probability of cancer in a patient. It does not have access to a patient’s medical history, symptoms or other factors of which the clinician may be aware. On this basis, the clinician always has the final say.
How is the test being evaluated in the NHS ?
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 complimented by a research project, funded by the Humber & North Yorkshire Cancer Alliance, which is investigating the potential of the PinPoint Test for non-site specific (NSS) pathways.
How has the test been developed and validated ?
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 these data, specifically logistic regression and gradient boosting.
Which tests are included in the PinPoint Test panel and are these different for each pathway?
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 the PinPoint Test is regulated, but the algorithm weights the information differently depending on the chosen referral pathway.
Will the intention be to use the PinPoint Test in association with other information - i.e. complimentary to FIT or demographics?
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.
Which laboratories will be used to process the PinPoint Test?
For the purposes of the PinPoint Service Evaluation, being run by West Yorkshire and Harrogate Cancer Alliance, bloods are being processed in Mid Yorkshire Hospitals NHS Trust. Laboratories in four further regions are being set up for PinPoint testing as part of a grant from SBRI Healthcare.
In future, the PinPoint Test can be processed in all NHS laboratories using standard equipment from any of the major providers. The EQA work to ensure results are standardised across regions is already underway as part of PinPoint’s preparation for clinical role out, with the support of NHS England & Improvement and SBRI Healthcare.
Can the PinPoint Test be used in vague symptoms pathways?
While the PinPoint Test is not currently CE marked for NHS vague symptoms pathways, the test is designed to be sensitive to all cancers. Future versions will be validated for this setting and more generally as a pan-cancer test.
PinPoint is working with the York & Scarborough Teaching Hospitals NHS Foundation Trust, Humber and North Yorkshire Cancer Alliance and York Rapid Diagnostic Centre to trial the use of the PinPoint Test in the Non-Site Specific urgent cancer referral pathway. This clinical research study is now part of the NIHR Clinical Research Network (CRN) Portfolio.
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