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Framework to Select Multi-Cancer Detection Assays in the National Cancer Institute's Vanguard Study.

Elyse LeeVan1, Amanda L Skarlupka1, Christos Patriotis1

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The National Cancer Institute (NCI) developed a framework to evaluate multi-cancer detection (MCD) tests for future cancer screening trials. This process identified promising MCD assays for the Vanguard Study, prioritizing technologies for clinical research.

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Area of Science:

  • Oncology
  • Biotechnology
  • Clinical Trials

Background:

  • The National Cancer Institute (NCI) established the Cancer Screening Research Network (CSRN) to advance cancer detection research.
  • The inaugural CSRN study, the Vanguard Study, aims to evaluate the feasibility of multi-cancer detection (MCD) tests in randomized controlled trials.

Purpose of the Study:

  • To outline the NCI's framework for engaging MCD assay developers.
  • To describe the methodology for evaluating emerging MCD technologies using biobank reference sets.
  • To detail the selection process for fit-for-purpose MCD assays for the Vanguard Study.

Main Methods:

  • Engaged MCD assay developers and evaluated 23 diverse assays utilizing AI and machine learning.
  • Conducted blinded performance evaluations on nine assays using specimens from three biobanks.
  • Provided independent performance assessments to developers for assay refinement.

Main Results:

  • Two assay companies were selected to participate in the Vanguard Study following the evaluation process.
  • Assay developers utilized independent assessments to enhance the performance of their MCD tests.
  • The framework facilitated a transparent and fair evaluation of MCD assay performance.

Conclusions:

  • The NCI established a robust process for selecting promising MCD assays for clinical research and public health.
  • This assay selection framework can be adopted by other institutions and networks for prioritizing cancer screening technologies.
  • Efficient selection of high-performing technologies is crucial for resource-intensive large-scale cancer screening trials.