Home » FDA Advisory Panel Endorses Blood Test for Primary Colon Cancer Screening

FDA Advisory Panel Endorses Blood Test for Primary Colon Cancer Screening

by Richard A Reagan

The U.S. Food and Drug Administration’s (FDA) Medical Devices Advisory Committee has endorsed the Shield™ blood test, a promising new tool for early detection of the disease. 

Developed by Guardant Health, the test targets adults aged 45 and older who are at average risk, aiming to increase screening rates and catch cancer earlier when it is most treatable.

During a recent panel meeting, experts voted overwhelmingly in favor of the test’s safety and effectiveness. 

The Shield test, if approved by the FDA later this year, could become the first FDA-approved blood test eligible for Medicare coverage that meets stringent performance standards for colorectal cancer screening.

Colorectal cancer remains the second-leading cause of cancer-related deaths in the U.S., yet one in three eligible Americans skip screening due to the invasive nature of current methods like colonoscopies. 

The Shield test offers a less daunting alternative, requiring only a simple blood draw, potentially increasing adherence and reducing cancer fatalities.

“Shield effectively detects cancer at an early stage when it is most treatable,” stated AmirAli Talasaz, co-CEO of Guardant Health. “Providing people with this blood test alongside other non-invasive tests can increase the rate of colorectal screening and potentially reduce preventable CRC deaths.”

Clinical results from the pivotal ECLIPSE study, published in The New England Journal of Medicine, revealed that Shield has an 83% sensitivity for detecting colorectal cancers, with a 90% specificity for advanced neoplasia. These metrics are competitive with current stool-based tests, which show sensitivities ranging from 67% to 92%.

Despite these promising results, some experts express caution. The test, while a valuable addition, has limitations in detecting pre-cancerous tumors and is less accurate compared to existing methods.

“Shield is better than nothing, but I don’t want to downplay the issue that this test is going to miss a lot of cancers,” said Charity Morgan, a panel member and biostatistics professor at the University of Alabama.

The FDA is expected to make a final decision on the approval of Shield by the end of the year. 

If approved, it will mark a significant milestone in offering more accessible and less invasive options for colorectal cancer screening, potentially saving thousands of lives annually. 

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