Colorectal Cancer: Investigational Blood Test Shows Promise for Early Detection

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An investigational blood-based test for early detection of colorectal cancer (CRC) met the primary endpoints of sensitivity and specificity in the PREEMPT CRC study, the largest study of any blood-based CRC screening test.¹

The data was presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium 2025, being held January 23-25 in San Francisco, California.¹

The prospective, registrational study evaluated the clinical performance of the Freenome blood-based test for detecting molecular signals of advanced colorectal neoplasia in average-risk adults, according to presenting author Aasma Shaukat, MD, MPH, director of outcomes research and Robert M. and Mary H. Glickman professor of medicine at NYU Grossman School of Medicine, and colleagues.¹

Shaukat and colleagues analyzed data from 27 010 participants aged 45 to 85 years who were scheduled for a screening colonoscopy (32.3% aged 55 to 65 years; 51.8% women). Study participants had no history of cancer, colorectal adenoma or inflammatory bowel disease, nor any family history of CRC.¹

The primary endpoints included sensitivity for CRC, specificity for advanced colorectal neoplasia (ACN), and negative and positive predictive value for ACN. A secondary endpoint was sensitivity for advanced precancerous lesions (APLs).¹

The blood-based screening test met all primary endpoints, demonstrating^1,2:

• 79.2% sensitivity for CRC detection
  • Stage I: 57.1%
  • Stage II: 100%
  • Stage III: 82.4%
  • Stage IV: 100%
• 91.5% specificity for ACN
• 90.8% negative predictive value for ACN
• 15.5% positive predictive value for ACN
• 12.5% sensitivity for APLs

After adjusting for US census data on age and sex, investigators found the blood-based test had similar sensitivity and specificity results.¹

“While physicians have screening tools available for colorectal cancer, the associated inconvenience and discomfort of these methods deter many from getting recommended screenings,” Shaukat said in a recent press release.² “By providing a more convenient option, Freenome’s blood test for the early detection of CRC has the potential to boost screening adherence rates and improve accessibility for people in all communities.”

References:

1. Shaukat A, Kutnik K, Meng Z, et al. Performance of a blood-based test for colorectal cancer screening adjusted to the US census age and sex distribution (abstract 18). Presented at: ASCO Gastrointestinal Cancers Symposium; Jan. 23-25, 2025; San Francisco.
2. Freenome announces topline results for PREEMPT CRC® to validate the first version of its blood-based test for the early detection of colorectal cancer. News release. Freenome. April 2, 2024. Accessed January 24, 2025. https://www.freenome.com/newsroom/freenome-announces-topline-results-for-preempt-crc-to-validate-the-first-version-of-its-blood-based-test-for-the-early-detection-of-colorectal-cancer/