| GRAIL Announces Submission of Final Module of Premarket Approval (PMA) Application to the U.S. Food and Drug Administration (FDA) for Its Galleri® Multi-Cancer Early Detection (MCED) Product。In fact, at JPM2026, everyone already knew what this PMA package was.It refers to the one-year follow-up data of 25,490 participants in the U.S. PATHFINDER 2 study, as well as the test performance and safety results from the first round of screening (the first year) in the NHS-Galleri trial.Previously announcedThe positive predictive value (PPV) is as high as 61.6%, nearly twice the previous value!Tissue of Origin Accuracy (CSO, cancer signal origin) reaches 91.7%.By the way, GRAIL mentioned that it received the FDA's Breakthrough Device Designation in 2018.However, what we found was from 2019.Anyway, the world's first MCED detection product (excluding those formed by simply combining two products) has experienced numerous challenges from its inception to obtaining certification (which is imminent).First acquired by Illumina, then jointly "pursued" by the FTC and the EU, later questioned by the wolves of Wall Street, and finally forced to be spun off from Illumina.Interested? Click into our official account's article collection and take your time to read.However, the capital market highly recognizes GRAIL and the underlying MCED technology.Since its listing, the stock price has surged 600%...。Friends who chose to get on board from the very beginning, please let me know in the comments section, and make everyone else envious...
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