Table 1

Defined consensus statements and corresponding levels of agreement

No.StatementStrongly agree (%)Tend to agree (%)Tend to disagree (%)Strongly disagree (%)Overall agreement (%)
Domain A: patient profile and type
1All patients should be tested for HER2, PD-L1 and MSI-H/dMMR at the time of diagnosis4634614 80
2All patients considered potentially suitable for systemic therapy should be tested for HER2, PD-L1 and MSI-H/dMMR6426010 90
Domain B: testing pathway ideals
3There is a need for clear guidance on which stage of the pathway PD-L1 testing should be used444826 92
4A centralised, testing service can provide more efficiency and quality control in the service425224 94
5PD-L1 testing should be completed in advance of MDTs to inform decision-making4244104 86
6Ideally, testing should be conducted within the prescribing institution2446264 70
7Variance in the testing pathway leads to delays in patients accessing appropriate treatment325882 90
8A delay in the diagnostic process may potentially prevent optimal treatment entirely if the patient’s disease worsens significantly484822 96
9It would be beneficial for automatic transfer of specific tissue cores to be in place for centralised processing3850102 88
10Treating physicians need to be informed promptly when there is insufficient tissue to satisfy testing requirements and so re-biopsy may be indicated663022 96
11Reflex testing at the point of diagnosis is more efficient than sequential testing and may reduce the time to initiation of treatment3844162 82
12Reflex testing at the point of diagnosis is more cost-effective than sequential testing3050164 80
13Reflex testing at the point of diagnosis is recommended in all patients considered potentially suitable for systemic therapy464626 92
Domain C: standards/benchmarks (including reference centre vs in-house testing vs regional hubs)
14Biomarker tests should be turned around within 10 working days425224 94
15Results of biomarker tests should be available no longer than five working days from the day the sample arrives at the pathology laboratory30481210 78
16Either in-house or outsourced, tests need to be delivered by an approved United Kingdom Accreditation Service laboratory524242 94
17The process from requesting a test to receiving the results is often unduly delayed by logistical issues3244204 76
18All test results should be made available on a single, integrated report504082 90
19All test results should be with the oncologist prior to the first consultation post diagnosis4838104 86
20If there is insufficient tissue for biomarker testing, this should be discussed at the MDT484822 96
21Treatment should be initiated within 30 days of receiving biomarker test results464482 90
22Positivity rates should be audited for the specific PD-L1 assay for comparison with literature-reported rates425242 94
Domain D: optimal roles and responsibilities to improve delivery of the testing pathway
23Clearly defined roles and responsibilities for each stage in the testing pathway would benefit the efficiency445222 96
24Lack of coordination between disciplines involved in the testing pathway can limit efficiency of the process385642 94
25A dedicated coordinator should be in place to plan, request and coordinate dissemination of the results of tests4044142 84
26The MDT is responsible for ensuring that the correct testing pathway is in place4838104 86
27The testing pathway should have agreed and documented time and KPI targets365284 88
28Testing pathway performance should be measured by the MDT3444184 78
29Business cases can benefit the establishment of consistent testing pathways that are efficient and accessible385642 94
Domain E: NHS system readiness
30Collaborative horizon scanning between NHS and industry would be beneficial to help NHS readiness306802 98
31Education of the entire MDT is vital to improve NHS system readiness for new tests and treatment modalities544222 96
32Any advent of technology and testing use needs to consider capacity concerns in the NHS504622 96
33Any advent of technology and testing use needs to consider resource requirements rather than just acquisition costs4634614 94
34NHS and NICE need to work more collaboratively so when new therapies are approved there is resource in the NHS provision for the accompanying biomarker test6426010 98
Domain F: future considerations
35A coordinated industry group to liaise with NHS and policymakers could help support future utilisation of new tests and modalities444826 92
36Artificial intelligence technologies have the potential to improve the speed with which test results are analysed and processed425224 88
  • dMMR, mismatch repair deficiency; HER2, human epidermal growth factor receptor 2; KPI, key performance indicator; MDT, multidisciplinary team; MSI-H, microsatellite instability high; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; PD-L1, programmed death ligand 1.