$80.000
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Noticias de GRAL
Eventos de GRAL
GRAIL's Galleri Test Application to be Reviewed by FDA on Sept. 23
GRAIL announced that the U.S. Food and Drug Administration's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is scheduled to meet on Sept. 23 to review the Premarket Approval application for the Galleri multi-cancer early detection blood test.The Galleri test is designed to detect cancer-specific methylation patterns shared by many types of cancer before symptoms appear, including cancers that do not have recommended screening today. When a cancer signal is detected, Galleri is designed to predict the cancer signal origin with high accuracy to help guide diagnostic evaluation. The test is intended to be used in addition to, and not as a replacement for, guideline-recommended screenings.
Grail Partners with Priority Health to Launch Galleri Multi-Cancer Early Detection
Grail announced a collaboration with Priority Health, a nonprofit health plan and the third largest provider-sponsored health plan in the nation, to make Grail's Galleri multi-cancer early detection - or MCED - test available to Priority Health's self-insured employer groups. Priority Health launched coverage for Galleri in its Thrive and Thrive Plus Medicare Advantage plans in 2025 and is expanding on its partnership with Grail to become the first Michigan health plan to enable its employer groups to easily add the Galleri test to their existing cancer screening coverage. Priority Health is a nonprofit health plan serving more than 1.4 million members across Michigan and beyond. With a simple blood draw, Galleri screens for many of the deadliest cancers before symptoms appear.
Grail Shares Drop 15.6% to $60.47
Grail is down -15.6%, or -$11.21 to $60.47.
Grail Shares Drop 18.4% to $58.50
Grail is down -18.4%, or -$13.18 to $58.50.
GRAIL Presents Positive Results from Pathfinder 2 Study
GRAIL announced that "positive" performance and safety results from the analysis of the full 35,878 cohort of its registrational Pathfinder 2 study are being presented during an oral session at the 2026 American Society of Clinical Oncology, ASCO, Annual Meeting. "The up to 6.5 fold improvement in screen-detected cancers with Galleri in PATHFINDER 2 study, coupled with the greater than 20% reduction in Stage 4 cancers observed in the NHS-Galleri trial, is really exciting data that help support Galleri's performance in a diverse and representative population," said Nima Nabavizadeh, MD, Associate Professor of Radiation Medicine at Oregon Health & Science University. "As an oncologist, I have seen too many patients diagnosed only after their cancer has spread, when treatment decisions become more difficult. By helping find more cancers earlier, when more treatment options may be available, there is great potential for multi-cancer early detection to transform cancer screening."
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