What's Happening?
Grail's Galleri multi-cancer early detection (MCED) test has demonstrated improved efficacy in the PATHFINDER 2 trial, with a 62% confirmation rate of positive results through follow-up testing. Conducted
over 12 months with 25,000 asymptomatic adults in the US and Canada, the study showed a significant increase in cancer detection when the test was added to standard screenings for various cancers. The test also correctly identified the cancer's origin in 90% of cases. Despite these advancements, some experts, like Prof Anna Schuh from the University of Oxford, express concerns over the test's readiness for widespread use, citing the detection rate as only marginally better than chance.
Why It's Important?
The Galleri test's ability to detect multiple cancer types, especially those without existing screening methods, could revolutionize early cancer detection and treatment. Early detection is crucial for improving survival rates, as many cancers are diagnosed too late for effective treatment. However, the test's high cost and the potential for false positives raise questions about its cost-effectiveness and practical application in public health. The test's approval and integration into healthcare systems could significantly impact cancer screening protocols and healthcare costs.
What's Next?
Grail plans to submit the study data to the FDA for premarket approval, aiming for completion in 2026. The company is also conducting a large-scale trial in the UK, with results expected next year. The outcomes of these regulatory processes and further studies will determine the test's future availability and use in clinical settings.
