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PREEMPT CRC: Blood-based CRC screening test shows promise

Presented by
Dr Aasma Shaukat, New York University, NY, USA
DDW 2024
The PREEMPT CRC study demonstrated that a novel blood-based test for colorectal cancer (CRC) screening met all primary endpoints, showing high sensitivity and specificity. The test could be an effective and convenient screening option, potentially increasing screening adherence rates.

Dr Aasma Shaukat (New York University, NY, USA) presented findings from the PREEMPT CRC study (NCT04369053) conducted between May 2020 and April 2022 [1]. It included 48,995 participants aged 45 to 85 years at average risk for CRC. Participants provided blood samples before the standard of care screening colonoscopy, and all colonoscopy and surgical reports were centrally reviewed. The study’s co-primary endpoints were sensitivity for CRC, specificity for non-advanced colorectal neoplasia (non-ACN), negative predictive value (NPV) for non-ACN, and positive predictive value (PPV) for ACN. The clinical validation cohort included 32,731 participants, with 27,010 having evaluable blood samples and colonoscopy results.

The blood-based test demonstrated a sensitivity for CRC detection of 79.2% (95% CI 68.4%–86.9%) and specificity for non-ACN of 91.5% (95% CI 91.2%–91.9%). The NPV for non-ACN was 90.8% (95% CI 90.7%–90.9%), and the PPV for ACN was 15.5% (95% CI 14.2%–16.8%). Sensitivity varied by CRC stage, being 57.1% at stage 1, 100% at stage 2, 82.4% at stage 3, and 100% at stage 4. The sensitivity for detecting advanced adenomas was 12.5% (95% CI 11.3%–13.8%), missing the pre-specified threshold by 0.2%. The study also evaluated a multiomics platform combining genomic and protein classification models that showed modest improvements in sensitivity for CRC and advanced adenomas.

The PREEMPT CRC study, the largest of its kind, validated the clinical performance of a blood-based CRC screening test. It demonstrated significant sensitivity and specificity, indicating it could provide a convenient and effective screening option for average-risk populations. Ongoing work aims to enhance the test's clinical performance further. Dr Shaukat concluded: "This new blood-based test may provide a convenient and effective option for CRC screening in the intended use population."

  1. Shaukat A, et al. Clinical evaluation of a blood-based screening test for the early detection of colorectal cancer. 1057d, DDW 2024, 18–21 May, Washington, DC, USA.

Medical writing support was provided by Federica Angius.

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