NCI Selects Two Assays for Vanguard Study on Multi-Cancer Detection Tests

The National Cancer Institute (NCI) has selected two assays for inclusion in the Vanguard Study on multi-cancer detection (MCD) tests, conducted by the Cancer Screening Research Network (CSRN). The selected assays are the Avantect® Multi-Cancer Detection Test by ClearNote Health and the Shield™ Multi-Cancer Detection Test by Guardant Health.

Launched in February 2024, the CSRN is a clinical trials network designed to evaluate emerging technologies for cancer screening, with the goal of reducing cancer-related deaths. The Vanguard Study, set to begin in 2025, will enroll up to 24,000 participants to assess the feasibility of using MCD tests in future randomized controlled trials. These trials aim to determine if the benefits of MCD tests in cancer screening outweigh the harms and if they can detect cancer early enough to reduce mortality rates.

The selection of the Avantect® and Shield™ tests followed a formal evaluation process initiated by the NCI in January 2022, which included a request for information to assess the availability and readiness of MCD tests for the study. A public workshop in May 2023 allowed MCD assay developers to apply for inclusion in the Vanguard Study. Selected assays underwent a performance verification process, with results and details on the selection process to be published in 2025.