GRAIL Submits FDA PMA for Galleri Multi-Cancer Early Detection Test

Core Insights - GRAIL, Inc. has submitted the final module of its premarket approval application to the FDA for the Galleri multi-cancer early detection test, which has received Breakthrough Device designation since 2018, indicating its potential to enhance early cancer detection [2][5] - The PMA submission is based on data from the PATHFINDER 2 study and the NHS-Galleri trial, which collectively involved over 25,000 participants, aiming to improve cancer detection rates, especially for high-mortality cancers that lack routine screening options [3][7][11] Company Developments - The Galleri test is positioned to significantly impact public health by improving early cancer detection rates, particularly for cancers diagnosed at advanced stages [3][5] - GRAIL's stock has seen a substantial increase of 195.1% over the past six months, outperforming the industry and S&P 500 [4] - The company currently has a market capitalization of $3.94 billion [6] Clinical Studies and Data - The NHS-Galleri trial enrolled over 140,000 asymptomatic individuals aged 50-77, focusing on reducing stage III-IV cancer diagnoses and assessing the test's performance across multiple cancer types [8] - The PATHFINDER 2 study aims to evaluate the safety and performance of the Galleri test in 35,000 participants, with primary endpoints related to diagnostic procedures following a cancer signal detected result [9][10] Market Prospects - The cancer diagnostics market is projected to grow from $170 billion in 2025 at a CAGR of 8.6% through 2034, driven by increasing cancer patient numbers and the benefits of early diagnosis [12][14] - GRAIL's collaboration with Samsung to commercialize the Galleri test in Asian markets, supported by a $110 million equity investment, enhances its international expansion strategy [17]