GRAIL aims to develop blood tests to detect cancer early, when treatment may be more successful. Reliable detection of cancer at earlier stages has the potential to decrease global cancer mortality and suffering. To achieve this, they are building intelligent models to identify clinically actionable information from vast amounts of tumor genome data obtained through high-intensity sequencing.

An increasing body of evidence suggests tumors release cell-free nucleic acids (cfNAs) into the bloodstream. cfNAs are small fragments of DNA and RNA, and reflect the genomic features of the tumor from which they originated. cfNAs are thought to be a direct measure of cancer and can be detectable in the bloodstream of people with cancer, potentially even before symptoms present. The fraction of tumor-derived cfNA in the bloodstream compared to cfNA from non-cancerous cells is very small, necessitating the ability to distinguish faint signals of early tumors from an overwhelming background of genomic material.

GRAIL feeds its large clinical and sequencing data sets into the bioinformatics and machine learning algorithms to distinguish with high accuracy the true invasive cancer signals from a sea of background biological noise.

The PATHFINDER Study is a prospective, multi-center study that will evaluate the implementation of GRAIL’s multi-cancer early detection test into clinical practice. GRAIL’s test is designed to detect and localize multiple types of cancer through a single blood draw, with a very low false positive rate. PATHFINDER is the first time GRAIL’s multi-cancer early detection test will be used to return results to healthcare providers and communicated to participants to help guide appropriate diagnostic workup for more than 50 cancer types. The study will enroll approximately 6,200 participants, and they will be followed for 12 months from the time of their enrollment.

The SUMMIT Study is a prospective, observational, longitudinal, cohort study being conducted in London in the United Kingdom. It is designed to enroll approximately 25,000 men and women age 50 to 77 years who do not have a cancer diagnosis at the time of enrollment. SUMMIT aims to further evaluate GRAIL’s blood test designed to detect multiple types of cancer, including lung cancer. The participants will be people at high risk of lung and other cancers due to a significant smoking history. Participants will be followed annually for three years and then will be followed for five years through national health registries as well as their medical records.

The Circulating Cell-free Genome Atlas (CCGA) Study is a prospective, observational, longitudinal, study designed to characterize the landscape of genomic cancer signals in the blood of people with and without cancer. The study has enrolled approximately 15,000 participants across 142 sites in the United States and Canada, and includes both people who had cancer at the time of enrollment (newly diagnosed, and not yet received treatment) and people who did not have a known cancer diagnosis. Planned follow-up for all participants is at least five years to collect clinical outcome data.

The STRIVE Study is a prospective, observational, longitudinal, cohort study that has enrolled approximately 100,000 women at the time of their screening mammogram. A subset of the data from STRIVE will be used to help validate GRAIL’s blood test for the early detection of multiple cancer types. Participants completed a health questionnaire and provided a blood sample around the time of their screening mammogram and will be followed for up to five years to capture clinical outcome data, including cancer diagnoses.

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