Defined consensus statements and corresponding levels of agreement
No. | Statement | Strongly agree (%) | Tend to agree (%) | Tend to disagree (%) | Strongly disagree (%) | Overall agreement (%) |
Domain A: patient profile and type | ||||||
1 | All patients should be tested for HER2, PD-L1 and MSI-H/dMMR at the time of diagnosis | 46 | 34 | 6 | 14 | 80 |
2 | All patients considered potentially suitable for systemic therapy should be tested for HER2, PD-L1 and MSI-H/dMMR | 64 | 26 | 0 | 10 | 90 |
Domain B: testing pathway ideals | ||||||
3 | There is a need for clear guidance on which stage of the pathway PD-L1 testing should be used | 44 | 48 | 2 | 6 | 92 |
4 | A centralised, testing service can provide more efficiency and quality control in the service | 42 | 52 | 2 | 4 | 94 |
5 | PD-L1 testing should be completed in advance of MDTs to inform decision-making | 42 | 44 | 10 | 4 | 86 |
6 | Ideally, testing should be conducted within the prescribing institution | 24 | 46 | 26 | 4 | 70 |
7 | Variance in the testing pathway leads to delays in patients accessing appropriate treatment | 32 | 58 | 8 | 2 | 90 |
8 | A delay in the diagnostic process may potentially prevent optimal treatment entirely if the patient’s disease worsens significantly | 48 | 48 | 2 | 2 | 96 |
9 | It would be beneficial for automatic transfer of specific tissue cores to be in place for centralised processing | 38 | 50 | 10 | 2 | 88 |
10 | Treating physicians need to be informed promptly when there is insufficient tissue to satisfy testing requirements and so re-biopsy may be indicated | 66 | 30 | 2 | 2 | 96 |
11 | Reflex testing at the point of diagnosis is more efficient than sequential testing and may reduce the time to initiation of treatment | 38 | 44 | 16 | 2 | 82 |
12 | Reflex testing at the point of diagnosis is more cost-effective than sequential testing | 30 | 50 | 16 | 4 | 80 |
13 | Reflex testing at the point of diagnosis is recommended in all patients considered potentially suitable for systemic therapy | 46 | 46 | 2 | 6 | 92 |
Domain C: standards/benchmarks (including reference centre vs in-house testing vs regional hubs) | ||||||
14 | Biomarker tests should be turned around within 10 working days | 42 | 52 | 2 | 4 | 94 |
15 | Results of biomarker tests should be available no longer than five working days from the day the sample arrives at the pathology laboratory | 30 | 48 | 12 | 10 | 78 |
16 | Either in-house or outsourced, tests need to be delivered by an approved United Kingdom Accreditation Service laboratory | 52 | 42 | 4 | 2 | 94 |
17 | The process from requesting a test to receiving the results is often unduly delayed by logistical issues | 32 | 44 | 20 | 4 | 76 |
18 | All test results should be made available on a single, integrated report | 50 | 40 | 8 | 2 | 90 |
19 | All test results should be with the oncologist prior to the first consultation post diagnosis | 48 | 38 | 10 | 4 | 86 |
20 | If there is insufficient tissue for biomarker testing, this should be discussed at the MDT | 48 | 48 | 2 | 2 | 96 |
21 | Treatment should be initiated within 30 days of receiving biomarker test results | 46 | 44 | 8 | 2 | 90 |
22 | Positivity rates should be audited for the specific PD-L1 assay for comparison with literature-reported rates | 42 | 52 | 4 | 2 | 94 |
Domain D: optimal roles and responsibilities to improve delivery of the testing pathway | ||||||
23 | Clearly defined roles and responsibilities for each stage in the testing pathway would benefit the efficiency | 44 | 52 | 2 | 2 | 96 |
24 | Lack of coordination between disciplines involved in the testing pathway can limit efficiency of the process | 38 | 56 | 4 | 2 | 94 |
25 | A dedicated coordinator should be in place to plan, request and coordinate dissemination of the results of tests | 40 | 44 | 14 | 2 | 84 |
26 | The MDT is responsible for ensuring that the correct testing pathway is in place | 48 | 38 | 10 | 4 | 86 |
27 | The testing pathway should have agreed and documented time and KPI targets | 36 | 52 | 8 | 4 | 88 |
28 | Testing pathway performance should be measured by the MDT | 34 | 44 | 18 | 4 | 78 |
29 | Business cases can benefit the establishment of consistent testing pathways that are efficient and accessible | 38 | 56 | 4 | 2 | 94 |
Domain E: NHS system readiness | ||||||
30 | Collaborative horizon scanning between NHS and industry would be beneficial to help NHS readiness | 30 | 68 | 0 | 2 | 98 |
31 | Education of the entire MDT is vital to improve NHS system readiness for new tests and treatment modalities | 54 | 42 | 2 | 2 | 96 |
32 | Any advent of technology and testing use needs to consider capacity concerns in the NHS | 50 | 46 | 2 | 2 | 96 |
33 | Any advent of technology and testing use needs to consider resource requirements rather than just acquisition costs | 46 | 34 | 6 | 14 | 94 |
34 | NHS and NICE need to work more collaboratively so when new therapies are approved there is resource in the NHS provision for the accompanying biomarker test | 64 | 26 | 0 | 10 | 98 |
Domain F: future considerations | ||||||
35 | A coordinated industry group to liaise with NHS and policymakers could help support future utilisation of new tests and modalities | 44 | 48 | 2 | 6 | 92 |
36 | Artificial intelligence technologies have the potential to improve the speed with which test results are analysed and processed | 42 | 52 | 2 | 4 | 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.