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Cancer Survival Analysis01:21

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Related Experiment Video

Updated: May 12, 2026

Integration of Wet and Dry Bench Processes Optimizes Targeted Next-generation Sequencing of Low-quality and Low-quantity Tumor Biopsies
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Performance of multiple multi-cancer detection tests using a large independent reference set (Alliance A212102).

Marie Wood1, Paul F Pinsky2, Paul Novotny3

  • 1Department of Medicine, University of Colorado Cancer Center, Aurora, CO, United States.

Journal of the National Cancer Institute
|January 7, 2026
PubMed
Summary
This summary is machine-generated.

Performance of multi-cancer detection (MCD) assays varied, with significantly lower sensitivity for early-stage cancers compared to late-stage. Tissue-of-origin accuracy was 75%.

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Area of Science:

  • Oncology
  • Biotechnology
  • Medical Diagnostics

Background:

  • Evaluating multi-cancer detection (MCD) assays requires robust reference sets.
  • The National Cancer Institute (NCI) initiated the Alliance reference set study to assess MCDs for clinical trial applicability.

Purpose of the Study:

  • To evaluate the performance of multiple MCD assays using a standardized reference set.
  • To assess sensitivity, specificity, and tissue-of-origin prediction accuracy of MCD assays.

Main Methods:

  • Recruited individuals with cancer and controls, collecting blood pre-treatment.
  • Designed a performance evaluation study using reference set samples from 6 participating companies.
  • Assayed samples for targeted, non-targeted, and control cancer types, reporting calls, risk scores, and tissue-of-origin predictions.

Main Results:

  • Included 549 cancer cases (13 types) and 413 controls.
  • Median specificity was 92.3%.
  • Median sensitivity was 32% (early stage) and 73% (late stage) by positive/negative calls (SEPN); 19% (early) and 66% (late) at 98% specificity (SE98). Median tissue-of-origin accuracy was 75%.

Conclusions:

  • Assay sensitivity and specificity showed considerable variation.
  • Early-stage cancer detection sensitivity was substantially lower than late-stage detection.
  • Tissue-of-origin prediction accuracy requires further improvement.