Impact case study database

Lung cancer accounts for 1,760,000 cancer deaths world-wide each year (World Health Organisation Statistics, 2018). Cambridge University-led research has established ctDNA liquid biopsy as a cornerstone of precision lung cancer medicine, with the aim of reducing this figure.

Impact on practitioners and the delivery of professional services

A clinically approved blood test for managing patients with NSCLC:

In 2018, the International Association for the Study of Lung Cancer (includes 9,000 lung cancer specialists in over 100 countries) convened a multidisciplinary panel of experts in the field of thoracic oncology to produce a set of recommendations for the use of liquid biopsy in the clinical management of advanced NSCLC patients. The panel reviewed a number of studies that had applied liquid biopsy technology to detect cancer-causing mutations (including [2]), and recommended that liquid biopsy be considered at the time of initial diagnosis in all patients with advanced NSCLC who need tumour molecular profiling, particularly when tumour tissue is scarce, unavailable, or for patients in whom invasive procedures may be risky or contraindicated. They also recommended that liquid biopsy be conducted at the time of initial diagnosis if the turnaround time for tissue biopsy is anticipated to be longer than 2 weeks [A].

Subsequently in 2019, IF-LLB received Medicare reimbursement approval in the US, providing the US population with routine access to a comprehensive genomic profiling test for NSCLC (one of only five such approved tests in the US) [B]. In February 2020, the US National Comprehensive Cancer Network guidelines, recommended use of liquid biopsies in advanced or metastatic NSCLC patients when tissue biopsy is not available: “ If there is insufficient tissue to allow testing for all of EGFR, ALK, ROS1, and BRAF, repeat biopsy and/or plasma testing should be done.” [C]. Liquid biopsies are now regarded as routine clinical practice as part of cancer care in the US. Furthermore, a 2020 systematic review which featured Pritchett et al., 2019 [5] noted that: “ctDNA molecular profiling is an accurate and reliable tool for the detection of clinically relevant molecular alterations in advanced NSCLC patients. Clinical outcomes with targeted therapies endorse the use of liquid biopsy by amplicon-based NGS ctDNA analysis in first line and relapse testing for advanced NSCLC patients.” [D].

[Text removed for publication] [B]. Two of these studies, including a large prospective EU clinical trial, investigated the potential of IF-LLB to reduce the time patients waited for treatment and to select treatments [E]. This work has underpinned the increased use of liquid biopsies in the routine management of patients with NSCLC lung cancer.

Leading international lung cancer oncologists attest to the positive impact of Inivata’s assays on treatment selection and patient care; an Associate Professor at the Stanford Cancer Institute says: “Data presented by Inivata has helped demonstrate the validity of their technology. This adds to the supportive data which is important in increasing the awareness and adoption of liquid biopsies for patient benefit.” [F]. An Associate Professor of Medicine at Harvard Medical School commented, “The impact of Inivata is clear. The company, based off your [Cambridge] research, has proven the validity and reliability of amplicon-based plasma NGS…had led the development of methods to monitor cancer noinvasively and use this monitoring to improve patient care..” [F].

The benefit to patients is further illustrated in an interview with the first patient to receive treatment based on his IF-LLB results in 2015, who said: “This test in fact triggered a change in therapy, which gave me almost 18 months of progression free survival until my cancer was mutated again. The liquid biopsies give me visibility, we’re not guessing anymore and can make an informed decision.” [F].

Supporting research of novel patient care pathways and therapies: In addition to use in routine clinical care, IF-LLB is also being used in ongoing studies to improve the NSCLC patient care pathway and develop new therapies. Inivata Ltd has established collaborations with Genomics England to assess ctDNA samples from the 100,000 Genomes Project to explore the potential of liquid biopsies to improve cancer management and patient outcomes in the UK [G]. IF-LLB will also be deployed in a GBP10,000,000 early cancer detection study of 15,000 participants (iDx-LUNG project). This national collaboration between academia and several major diagnostics and informatics companies will test ways to detect cancer at a stage when it can be cured. IF-LLB will be used to analyse blood samples from patients with inconclusive CT scan results participating in NHS England Targeted Lung Health Checks[G].

Impact on commerce and the economy

In 2014, Dr Rosenfeld and colleagues in Cambridge founded the spinout company Inivata Ltd, as a global clinical cancer genomics company developing its proprietary, industry-leading liquid biopsy platform to transform patient care [E]. The company has raised USD129,400,000 (~GBP96,800,000) and employs >80 highly-skilled individuals at its headquarters and R&D centre in Cambridgeshire and its certified clinical laboratory in North Carolina [H]. In March 2015, the further development of Inivata Ltd. technology was enabled through a collaboration with MedStar Health, a US not-for-profit health care provider [I]. To commercialise IF-LLB in the US, in May 2020 Inivata Ltd., then formed a strategic partnership with Neogenomics that made a USD25,000,000 equity investment in UK-based Inivata Ltd., Cambridge [I]. In July 2019, Inivata Ltd., signed a distribution agreement with IPS Genomix, part of the IPS Group, to provide cancer patients and partners in the Middle East and Africa with access to its IF-LLB test and other liquid biopsy tests [I].