> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Panel to Review Colon Cancer Blood Test
- URL: https://www.fdaweb.com/panel-to-review-colon-cancer-blood-test/
- Published: 2024-04-22T12:00:00.000Z
- Updated: 2026-09-14T14:28:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5156824

FDA’s Medical Devices Advisory Committee’s Molecular and Clinical Genetics Panel is scheduled to review a Guardant Health PMA for its Shield blood test for colorectal cancer (CRC) screening on 5/23\. The expert panel will discuss the clinical data from the company’s ECLIPSE study and the potential for the Shield blood test to “overcome the barriers of current screening methods and offer a new, more convenient screening option that will detect colorectal cancer in the early stages, when it is most treatable,” Guardant says.

ECLIPSE (Evaluation of ctDNA LUNAR Assay In an Average Patient Screening Episode) is a 20,000-plus patient registrational study designed to evaluate the performance of Shield compared to a screening colonoscopy. “The Shield test detects colorectal cancer signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA),” the company says. In the study, Shield demonstrated 83% sensitivity in detecting individuals with CRC and 88% sensitivity in detecting pathology-confirmed Stages I-III, it adds.