Date Posted
The National Cancer Institute (NCI) has selected two assays to be included in the Vanguard Study on multi-cancer detection (MCD) tests which will be conducted by the Cancer Screening Research Network (CSRN). The two assays selected, in alphabetical order, are the Avantect® Multi-Cancer Detection Test by ClearNote Health, headquartered in San Diego, California, and Shield™ Multi-Cancer Detection Test by Guardant Health, headquartered in Palo Alto, California.
In February 2024, NCI launched the CSRN, a clinical trials network created to evaluate emerging technologies for cancer screening with the ultimate goal of reducing cancer-related deaths. In 2025, the CSRN will launch the Vanguard Study to address the feasibility of using MCD tests in future randomized controlled trials. The Vanguard Study will enroll up to 24,000 people to inform the design of a much larger randomized controlled trial. This larger trial will evaluate whether the benefits of using MCD tests to screen for cancer outweigh the harms, and whether they can detect cancer early in a way that reduces deaths.
NCI selected the Avantect® Multi-Cancer Detection Test by ClearNote Health and the Shield™ Multi-Cancer Detection Test by Guardant Health based on a formal evaluation process. The process started with a request for information (NOT-CA-22-033) released in January 2022 to assess both the availability and readiness of MCD tests for inclusion in the Vanguard Study and the willingness of MCD assay developers to participate.
In May of 2023, NCI hosted a public workshop to engage MCD assay developers (NOT-CA-23-055) in the process. At this public workshop, NCI invited companies to apply to have their assays considered for inclusion in the Vanguard Study. Assay developers needed to provide a formal application. Selected assays were identified for a performance verification process. NCI sent those companies a blinded reference set to test their assays on specimens from the Alliance for Clinical Trials in Oncology and companies sent their results back to NCI for analysis. Results from the NCI verification study and details on the assay selection process will be published in 2025.
Read the company press releases:
- ClearNote Health’s Avantect® Multi-Cancer Detection Test Selected as One of Two Noninvasive Blood-Based Technologies for National Cancer Institute’s Vanguard Study
- Guardant Health Shield platform selected for inclusion in the National Cancer Institute’s Vanguard Study to evaluate emerging technologies for multi-cancer detection
Learn more about the CSRN: