Written evidence submitted by Guardant Health (CBP0054)
Thank you for inviting evidence from stakeholders to inform your inquiry on the extent of the backlog caused by the COVID-19 pandemic and how the NHS can be supported to manage this demand. This submission from Guardant Health, a leading provider of liquid biopsy tests that support cancer care, sets out:
- Information about advanced diagnostics and Guardant Health
- Evidence on the impact of the pandemic on cancer services
- How innovative advanced diagnostics can be utilised to help manage this backlog
- Current challenges to use of advanced diagnostics in the NHS, and suggestions for how these can be overcome
Advanced diagnostics, such as liquid biopsies, can have a transformative effect on cancer pathways and outcomes, enabling patients to access effective treatments much more quickly and equitably, as the process is based on a simple blood draw. As such, they could play a key role in managing the significant backlog in cancer services caused by the pandemic. Currently however, systemic barriers prevent many patients from accessing the benefits of these innovative technologies. From our perspective, it is vital that the Committee looks into:
- How the Government and NHS plan to embed the utilisation of advanced technologies into COVID-19 recovery planning for cancer services
- How the Government could support and facilitate expedited roll-out of transformative innovations such as liquid biopsies in NHS cancer services, including through the ongoing development of the Diagnostics Strategy
- How the Government could bring together the whole ecosystem – including industry – to co-create a route by which the NHS, patients and research infrastructure can routinely realise the clinical and efficiency benefits of advanced diagnostics
About Guardant Health and our technology
- Advanced diagnostics exploit today’s improved understanding of human genes and their functions – by applying technologies such as Comprehensive Genomic Profiling (CGP) and Whole Genome Sequencing (WGS) to better understand the biological changes driving disease. With the range of information that advanced diagnostics can reveal, they present a paradigm shift in medicine, and can be used for a variety of research and clinical applications including screening for disease, diagnosis, prognosis, treatment selection, monitoring risk of recurrence, and early detection of disease.
- Liquid biopsies, a type of advanced diagnostic, are tests of fluid – mostly blood – sample, which, when used in oncology, can analyse circulating biological material shed from a cancer patient’s tumour(s) into their bloodstream, to identify the molecular changes occurring in a tumour. Through better understanding of the biological makeup and evolution of the tumour, clinicians can rapidly select tailored interventions to help them most effectively treat the disease and improve clinical outcomes. This is known as precision oncology.
- Guardant Health is a precision oncology company which aims to transform the treatment and management of cancer by developing blood-based, industry-leading diagnostic technologies. Our liquid biopsy test, Guardant360 CDx is the first FDA-approved liquid biopsy comprehensive genomic profiling service and is already used extensively in the United States to support the treatment of those with advanced cancers. The technology has high specificity and sensitivity and is similar in performance to traditional tissue biopsies, while being significantly less invasive.
The impact of the pandemic on NHS cancer services
- Like most key NHS specialties, the impact of the COVID-19 pandemic on both diagnosis and treatment of cancer is well documented and has become a matter of urgent concern for NHS providers, patients and the public. The pandemic has drastically exacerbated strain on existing resources, not only causing delays, but limiting access to cancer diagnosis and treatment for many patients.
- Recent analysis by Cancer Research UK on cancer services during the first year of the pandemic (April 2020 – March 2021) found that: 
- 3 million fewer people were screened in the UK between March and September 2020. The number of patients starting cancer treatment having been diagnosed through screening in England was 42% lower in April 2020-March 2021 compared with pre-pandemic
- There were more than 380,000 fewer urgent suspected cancer referrals in the UK between March 2020 and March 2021 – down 13% compared with pre-pandemic. At least 23,000 of these were for suspected lung cancers
- For the seven key diagnostic tests which can be used to diagnose cancer, the number carried out in England was 4.6m (21%) lower in March 2020-March 2021 compared with pre-pandemic. The number of people waiting 6+ weeks for diagnostic tests has increased to more than 215,000 compared to March 2020, when waiting time numbers were at around 66,700
- 45.5K (13%) fewer patients started cancer treatment in the UK in April 2020- March 2021 compared with pre-pandemic. In England, 2,700 of these ‘missing cancers’ were lung cancers.
- These concerning statistics highlight the scale of the challenge faced by cancer services throughout COVID-19. Furthermore, the pressure caused by the backlog will not be quick to ease as we move beyond the pandemic. It has been estimated that delays in diagnosis treatment will result in 3,000 excess cancer-related deaths in breast, colorectal, oesophageal and lung cancers alone within five years.
- To help NHS cancer services cope with this unprecedented pressure, and avoid poorer outcomes for patients wherever possible, we recommend the Committee inquires as to how the NHS plans to sufficiently seize every opportunity, including advanced diagnostics, that might help patients efficiently process through the system to access the appropriate care they urgently need.
The potential role of advanced diagnostics in managing the cancer backlog
- There is clear evidence that advanced diagnostics such as validated liquid biopsies can help cancer services to treat patients both more efficiently and more effectively. In the NHS, tissue biopsies are routinely used both to diagnose and better understand a wide range of cancer types. However, the procedures are invasive, can be costly and time-consuming to conduct – often resulting in many essential test results not being delivered on time, or at all, for advanced cancer patients.. Taking non-small cell lung cancer as a specific example, many patients are currently ineligible for, or delayed in completing, genotyping conducted through tissue biopsies. Even before COVID-19, a significant proportion of NHS cancer services did not meet the 62-day treatment target in lung cancer. Unlike traditional tissue biopsies, liquid biopsies are non-invasive, while Guardant360 has a fast turnaround time of 7 days from blood draw to report which helps tackle delays in identifying and initiating appropriate treatments
- A recent Royal Marsden-led study has demonstrated the benefits that validated liquid biopsies such as Guardant360 can have for patients with advanced cancers, whilst helping cancer services to treat patients more efficiently and reduce the time and cost burdens associated with tissue biopsies and ineffective treatments.
- While this was a relatively small-scale study, implementation of these technologies as a standard of care across NHS cancer services could have a material impact on the NHS’s ability to manage the current and future backlog in patients requiring cancer care.
- Currently however, systemic barriers hinder the wider roll-out of these technologies in the NHS:
- An absence of a comprehensive strategy for the delivery of Government and NHS commitments on genomic healthcare, which has hindered the development of a clear plan for utilising advanced diagnostics at the local level
- A lack of clarity on reimbursement, with none of the multiplicity of potential routes for reimbursement currently in place being well-suited for advanced diagnostics
- An immature system within the NHS, as NHS Genomic Medicine Service Alliances are yet to become fully established and may entrench obsolete standards of care in the future.
- As such, the role that advanced diagnostics such as liquid biopsies could play in driving down the backlog in cancer services cannot be fully leveraged. In the course of its inquiry, the Committee may wish to explore how the Government could support and facilitate expedited roll-out of transformative innovations such as liquid biopsies in NHS cancer services, including through the ongoing development of the Diagnostics Strategy.
What needs to happen now
- As policymakers rightly continue to focus on the NHS’s ongoing recovery from COVID-19, an opportunity exists to explore establishing a clear pathway from assessment to reimbursement for use of liquid biopsies in advanced cancers, so that NHS services and patients nationally have unrestricted access to their benefits at a time when they are most needed.
- The advanced diagnostics sector is well-placed to support innovation in NHS cancer services, working alongside public sector partners. To that end, the Committee may wish to explore how the Government could bring together the whole ecosystem – including industry – to co-create a route by which the NHS, patients and research infrastructure can routinely realise the clinical and efficiency benefits of advanced diagnostics
Guardant Health, August 2021
 EUCOPE, Developing an advanced diagnostics ecosystem in Europe: A proposal for change. 2021, accessed August 2021
 Cancer Research UK, Evidence of the impact ofCOVID-19 across the cancer pathway: Key Stats. Last updated 10 June 2021, accessed August 2021 https://www.cancerresearchuk.org/sites/default/files/cruk_covid_and_cancer_key_stats_june_2021.pdf
 Maringe, Camille, et al. “The Impact of the COVID-19 Pandemic on Cancer Deaths Due to Delays in Diagnosis in England, UK: A National, Population-Based, Modelling Study.” The Lancet Oncology, vol. 21, no. 8, Aug. 2020, pp. 1023–34. www.thelancet.com, doi:10.1016/S1470-2045(20)30388-0, accessed August 2021 https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30388-0/fulltext
 Royal Marsden NHS Foundation Trust. (2020) Using liquid biopsies as an alternative diagnostic test to protect patients and staff. Available from: https://www.royalmarsden.nhs.uk/using-liquid-biopsies-alternative-diagnostic-test-protect-patients-and-staff [Accessed 23 August 2021]
 The Royal Marsden NHS Foundation Trust, Detection Of Tier 1 Variants With Circulating Tumour (ct) DNA Next Generation Sequencing (NGS) In UK Non-Small Cell Lung Cancer (NSCLC) Patients, accessed August 2021, data on file