By Allison Proffitt
January 15, 2025 | Grail presented for the first time at the 42rd Annual J.P. Morgan Healthcare conference today, and Bob Ragusa, CEO, took the stage, pleased to be there.
Grail was divested from Illumina and became an independent, publicly traded company in June 2024 and underwent a significant restructuring in August 2024. But while the company structure has changed significantly in 2024, the mission has not, Ragusa said: detecting cancer early, when it can be cured.
Grail is an early mover in the MCED space: multi-cancer early detection. The commercial product, Galleri, is a blood test that looks for circulating tumor DNA shed from tumors well before they cause physical symptoms. Galleri was awarded a breakthrough device designation from FDA in 2019.
The case for MCED was made in a 2018 paper published in the npj Precision Oncology (DOI: 10.1038/s41698-018-0066-x), which talks about how positive predictive value (PPV)—meaning the likelihood that a positive test result is actually positive—is driven by both the prevalence of cancer in a population and the specificity or the false-positive rate. Grail views Galleri as a population-scale test and believes that MCED is the solution for effective population screening.
The opportunity for multi-cancer early detection is “enormous”, Ragusa said, estimating a total addressable market in the US of over 100 million individuals and more than 300 million when you add the US, UK, EU, and Japan. Grail has so far completed more than 290,000 Galleri commercial tests, Ragusa reported. “Across that many tests, we are routinely finding deadly cancers in our population,” he said. “The value of the Galleri test is its ability to find cancers that aren’t screened for today, and our biggest opportunity is deploying the test in a reimbursed environment to screening-eligible, asymptomatic patients both in the U.S. and abroad.”
Galleri Groundwork
Galleri has been available as a laboratory-developed test for about three years, but Ragusa hopes that the path to FDA-approval (and broad commercial reimbursement) is very close. In 2025, the company expects to read out foundational data and early results from the 35,000-participant Pathfinder 2 study. In 2026, they expect final data from the longitudinal 140,000-participant NHS Galleri study. Ragusa foresees recommending Galleri as an annual test, though the NHS longitudinal study will clarify the right cadence for repeat testing, he said.
But while those study results are forthcoming, Grail has been busy focusing on efficiency and setting up larger research programs and infrastructure investments to be poised for scale. The company’s 170,000 square feet of laboratory infrastructure is ready in Research Triangle Park, North Carolina. He predicts no additional capital investment needed to support several years of growth.
Grail began shipping a new version of Galleri in December, which has “substantially expanded our capacity,” Ragusa said. The new test version is both “fully automated and integrated”, eliminating many laboratory steps for greater quality control. The company reduced the panel to the most informative regions, he added, “allowing us to run four times the number of samples on a flow cell and reduce sequencing costs.” The new version of the test also has an updated test report, which revises how the cancer signal-of-origin (CSO) is classified to simplify it to 18 regions, to, “provide more valuable information to physicians.”