PREEMPT CRC: Blood-based screening test for colorectal cancer shows promise

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. This test could offer a convenient and effective alternative to traditional methods, potentially improving screening adherence rates.

Dr Aasma Shaukat (New York University, NY, USA) presented the 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. Blood samples were collected before participants underwent standard-of-care colonoscopies. All colonoscopy reports were centrally reviewed. The co-primary endpoints included 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% and specificity for non-ACN of 91.5%. The NPV for non-ACN was 90.8%, and the PPV for ACN was 15.5% (see Table). 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%, slightly missing the pre-specified threshold by 0.2%. The study also evaluated a multi-omics platform combining genomic and protein classification models, which showed modest improvements in sensitivity for CRC and advanced adenomas.

Table: Sensitivity and specificity of the blood-based screening test [1]



CRC, colorectal cancer; ACN, advanced colorectal neoplasia.

The PREEMPT CRC study, the largest of its kind to date, validated the clinical performance of a blood-based CRC screening test, by demonstrating its high sensitivity and specificity. Ongoing work aims to further enhance the test's clinical performance. “This new blood-based test may provide a convenient and effective option for CRC screening in the intended use population,” Dr Shaukat concluded.

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   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.

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Posted on 11 July 202411 July 2024