Natera announces data from PROCEED-CRC trial

Natera (NTRA) announced another readout for its ECD program, which is evaluating a blood-based screening test for the detection of CRC and advanced adenomas. This latest analysis from the U.S. based, prospective PROCEED-CRC clinical trial focused on the detection of AAs, which are precancerous polyps with specific features that indicate a higher risk of progression to colorectal cancer. PROCEED-CRC has enrolled approximately 5,000 average-risk asymptomatic screening participants with blood draws taken pre-colonoscopy. This analysis started with approximately 1,400 PROCEED-CRC cases that were collected prior to the cutoff date, incorporating 92 sequentially collected AA samples and a representative cohort of 366 normal controls. The study showed sensitivity of 22.5% and specificity of 91.5% and encompassed all histologic subtypes, including serrated polyps. When adjusted for subtype prevalences found in two recent CRC screening FDA-enabling trials, sensitivity was 22.4% and 23.7%. Additionally, in this study, 98.9% of AA cases were less than 30 millimeters and 93.5% were below 20 millimeters, which represents a challenging size distribution because smaller lesions can be more difficult to detect. Earlier in 2025, Natera reported preliminary AA performance data from a pilot study with 18% sensitivity and 91% specificity. Since that time, several technology changes have resulted in improved assay performance. These findings create increased confidence going into the FIND clinical trial, an FDA-grade validation study, which was initiated in 2025 and continues to make significant progress.