Now operating on its own, Grail is moving forward with large-scale clinical trials for its Galleri multi-cancer early detection blood test, as it ultimately aims to secure a premarket approval from the FDA and greater adoption worldwide.
The company, which completed its split from Illumina in late June, reported that it is nearing the finish line for its massive, national-scale study spanning more than 140,000 participants, currently being conducted through the U.K. National Health Service.
First launched in 2021, the randomized NHS-Galleri trial tapped a representative group of people between the ages of 50 and 77, to examine how the blood test would work alongside standard-of-care cancer screenings—with the goal of reducing the overall number of late-stage, hard-to-treat tumors by catching them earlier.
Grail said the trial was fully enrolled within 10 months—and now, all participants have completed the study’s regimen of having three blood draws taken over a two-year period.
Half of the samples were tested with Galleri while half were stored for future analysis. Any patient with a positive result was to be referred for a full diagnostic workup. The final results are slated for 2026.
Meanwhile, Grail also announced that it has enrolled more than 35,000 participants for its latest study, dubbed PATHFINDER 2. Its predecessor had gathered about 6,600 people to examine the time and additional testing necessary to diagnose a patient’s cancer following a positive blood result.
The expanded sequel study targets a population of people in the U.S., ages 50 years and older, who are currently eligible for traditional, guideline-recommended cancer screening check-ups. It started enrolling patients in December 2021 and aims to explore Galleri’s sensitivity and specificity in detecting as many as 50 different cancers, as well as its ability to trace tumor DNA in the bloodstream back to its organ of origin.
It will also track the test’s overall safety and effectiveness, including subsequent diagnostic exams and biopsies, in addition to patient-reported outcomes and measures of personal anxiety. Results from the first 25,000 enrolled participants are expected in the latter half of next year.
“Both studies were designed to enroll a diverse participant population, representative of socio-economic, ethnicity, gender and age differences, and we are proud of the diversity of the study populations,” Grail CEO Bob Ragusa said in a statement.
“The data from these studies, as well as supplemental data from our other clinical studies, will support our premarket approval application submission for Galleri to the FDA, which is currently in process with a modular submission under a Breakthrough Device Designation from the FDA,” Ragusa added.
Grail also announced that it has signed up its first participant for a new U.S. trial aimed at Medicare users. The REACH/Galleri-Medicare study will look to assemble real-world evidence of the blood test’s use among up to 50,000 beneficiaries over a three-year period.
The company estimates that about 70% of the people who died from cancer in the U.S. last year were 65 years of age or older, while more than half of all cancer diagnoses are in Medicare beneficiaries.