On October 28, 2025 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported another successful readout for its ECD program, which is evaluating a blood-based screening test for the detection of CRC and advanced adenomas (AA). This latest analysis from the U.S. based, prospective PROCEED-CRC clinical trial (NCT06620627) focused on the detection of AAs, which are precancerous polyps with specific features that indicate a higher risk of progression to colorectal cancer. Detecting these lesions early is a critical step in preventing cancer before it develops.
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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% (CI: 15.4%-32.4%) and specificity of 91.5% (CI: 88.2%-93.9%) and encompassed all histologic subtypes, including serrated polyps. When adjusted for subtype prevalences found in two recent CRC screening FDA-enabling trials1,2, 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 (NCT07046585), an FDA-grade validation study, which was initiated in 2025 and continues to make significant progress.
"This data represents another important milestone in our efforts to advance blood-based colorectal cancer screening," said Alexey Aleshin, M.D., general manager of oncology and early cancer detection, and chief medical officer at Natera. "Detecting advanced adenomas is critical for intercepting colorectal cancer before it develops, and this exceptional performance highlights the strong potential of our technology to transform early detection."
These results build on previously reported case-control data from screen-detected CRC cases, which were also announced earlier this year showing overall sensitivity of 95% (95% CI: 92-99%) and specificity of 91% (95% CI: 88-94%). Among patients with stage I disease, sensitivity was 92% overall. Stage-adjusted sensitivity was 91% in screen-detected individuals.
(Press release, Natera, OCT 28, 2025, View Source [SID1234657087])