GRANITE-001 gets FDA Fast Track for colorectal cancer

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Gritstone Oncology Inc. said FDA has granted Fast Track designation to GRANITE-001 for the treatment of colorectal cancer. GRANITE-001 is a personalized immunotherapy containing patient-specific neoantigens identified by Gritstone’s proprietary EDGETM artificial intelligence platform as the most relevant neoantigens to drive a tumor-specific T-cell attack.

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For decades, we have faced a central challenge in colorectal cancer screening. One in three eligible Americans—over 50 million people—remain unscreened despite established methods like colonoscopy or stool-based tests existing for decades. This gap persists even though early detection saves lives, and even as colorectal cancer is now the number one cancer killer for Americans under 50.

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