ACCelerate - Refinement and implementation of a rapid urine test for the detection of adrenal cancer

The number of adrenal tumours discovered incidentally is increasing due to the widespread use of cross-sectional imaging. Currently, patients with an adrenal tumour will regularly undergo multiple scans to decide if surgery is needed, requiring several hospital visits and creating a burden for affected patients and the NHS. In addition, patients are often left anxiously waiting for answers between appointments, which may be many weeks or months apart. Furthermore, currently used imaging approaches have poor specificity for determining if an adrenal tumour is a malignant adrenocortical carcinoma (ACC), eventually diagnosed in 5% of patients with adrenal tumours undergoing workup. Of those patients undergoing surgical removal of their adrenal tumour due to suspicion of malignancy, 38% turn out to have a benign mass that did not require surgery. Our proposed diagnostic, ACCelerate, addresses this unmet clinical need. ACCelerate is based on the combination of urine steroid analysis by tandem mass spectrometry (LC-MS/MS) with a clinically validated machine learning algorithm that looks for the urine steroid “fingerprint” of ACC. ACCelerate is already at an advanced stage of innovation and is underpinned by granted patent intellectual property. ACCelerate has been clinically validated in a large-scale multi-centre study and shown to be 4 times more accurate at diagnosing malignancy than CT scans alone. The key value driver for the NHS will be the rapid regulatory approval and introduction of ACCelerate into routine clinical pathways. By working with certified NHS laboratories, we propose a low-risk route-to-market approach where our test integrates into existing diagnostic pathways and obviates the need for costly lab and capital equipment investment. This proposal will also significantly reduce the implementation risk of ACCelerate. This will include standardisation of the diagnostic at this early stage with optimised mass spectrometry methods and regulatory certified standards to ensure that each test conforms to the highest regulatory quality standards. ACCelerate will be underpinned by robust clinical data generated to the highest standards and with key stakeholders, generating a highly reliable, non-invasive, radiation free test that supports patients’ safety and reduces healthcare burden. The value of successfully delivering this project will be in alleviating the burden on specialist referral centres by providing a faster and safer non-invasive diagnostic test (ACCelerate). We have a strong clinician-led team that has experience in PPIE, regulatory and project management to deliver a successful project. The co-lead partner SME, IMS Solutions, is ideally placed to commercialise the outputs of the project. The objectives of the project are to: (1) achieve a regulatory certified diagnostic for the UK market and (2) generate the high-quality evidence and stakeholder buy-in required for rapid adoption into the NHS. This will include a comprehensive pre-implementation and simulation-based evaluation of ACCelerate, including human factors assessment and health economics analysis, to confirm cost effectiveness and identify any barriers, alongside continuous running of PPIE activities to ensure wide and equal accessibility. We anticipate clinical use of the ACCelerate diagnostic in early adopting centres by the end of this 36-month project.