Genomics company Grail has revealed ambitious plans to deploy its investigational cancer detecting blood test into 50,000 people in what will be one of the largest clinical research programmes ever pursued in genomic medicine.
The study, called SUMMIT, will be conducted in the UK, recruiting men and women aged 50-77 years who do not have a cancer diagnosis at the time of enrolment.
Participants will be divided into two groups: those at a high risk of lung and other cancers due to a significant smoking history and those who are not at high risk of cancer based on their smoking history.
Both subgroups will receive the blood test, which uses next-generation sequencing technology to detect multiple cancer types.
The company says that tumours release small fragments of DNA and RNA called cell-free nucleic acids (cfNAs) into the bloodstream, and they reflect the genomic features of the tumour from which they originated.
Remarkably, these cfNAs could potentially be detected before the manifestation of cancer symptoms.
However, the fraction of tumour-derived cfNAs in the bloodstream compared to cfNAs from non-cancerous cells is very small, so the company plans to feed the data collected from the trial into its bioinformatics and machine learning algorithms in order to distinguish the difference.
“The SUMMIT study will support the development of our blood test for the early detection of multiple cancer types in a diverse population,” said Anne-Renee Hartman, vice president of Clinical Development at GRAIL.
Anne-Renee Hartman
Hartman also announced that Grail will work with the University College London Hospitals NHS Foundation Trust (UCLH) and University College London along with the Lung Cancer Alliance to conduct the trial.
“We have a common goal with GRAIL in conducting the SUMMIT study – the early detection of cancer,” said Sam Janes, Professor of Respiratory Medicine at UCL and Principal Investigator of the SUMMIT study.
“By working together, we hope to bring lung cancer screening to people in the United Kingdom, while we also deepen our understanding of potential new technologies for early cancer detection.”
According to UCLH, around 75% of lung cancers are diagnosed at a late stage and only 25% of cases are diagnosed at stages 1 and 2. If lung cancer was diagnosed at the earliest stage, 70% of all lung cancer patients will survive for at least a year, compared to around 14% of those diagnosed with the most advanced stage of the disease.
Janes told UCLH that: “Lung cancer is the biggest cancer killer in the UK because most people only experience symptoms when the cancer is at an advanced stage when it is very difficult to treat. This large-scale study gives us a unique opportunity to detect lung cancer much earlier when treatment is more likely to be successful amongst those proven to be most at risk.”
Additionally, Grail is conducting two other large-scale studies, which are designed to characterise the landscape of genomic cancer signals in the blood, and to develop and evaluate Grail’s blood test for the early detection of multiple cancer types.
Genomic medicine is already making waves in the UK. Earlier this year, Genomics England announced a deal with Congenica to deliver diagnostic decision support services as part of the upcoming NHS Genomic Medicines Service.
That initiative builds on the 100,000 Genome Project, and data from that could soon be integrated into medical records, a move which could help the UK’s NHS become a world leader in introducing genomic-based treatment into the mainstream healthcare services.
Grail is far from being the only company active in the early cancer detection field, which has seen dozens of new tech, genomics and diagnostics entrants spring up over the last 5-10 years. Another firm active in the UK is Owlstone Medical, which is developing a Breath Biopsy device to detect cancers in volatile organic compounds (VOCs) found patients’ exhaled breath.