FDA gives green light to Guardant Health’s Shield blood test: A game-changer in colorectal cancer screening and Medicare coverage

In a landmark decision, the U.S. Food and Drug Administration (FDA) has approved Guardant Health, Inc.’s Shield blood test as a primary screening option for colorectal cancer (CRC). This groundbreaking move marks the first time a blood test has been sanctioned by the FDA for CRC screening, offering a non-invasive alternative to traditional methods.

Guardant Health, a prominent precision oncology firm, announced the approval today, underscoring the significance of Shield in revolutionizing CRC screening for adults aged 45 and older who are at average risk. The Shield test’s approval not only provides a new option for early cancer detection but also positions it as the first blood test for CRC to meet Medicare coverage requirements.

Colorectal cancer remains the second-leading cause of cancer-related deaths in the United States. Despite being highly treatable when detected early, it continues to claim lives due to low screening rates. The American Cancer Society estimates that over 150,000 individuals will be diagnosed with CRC this year, with more than 53,000 expected deaths. Alarmingly, over 75% of those who die from CRC are not current with their screening.

Addressing the Screening Gap

Current CRC screening rates in the U.S. are approximately 59%, significantly below the National Colorectal Cancer Roundtable’s target of 80%. Many Americans, more than 50 million, avoid screening due to the invasive, inconvenient nature of existing methods like colonoscopy and stool-based tests.

Daniel Chung, MD, a gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School, highlighted the impact of the Shield blood test in bridging this screening gap. The FDA’s approval represents a major advancement, making CRC screening more accessible and appealing, potentially leading to higher detection rates and saving more lives.

Shield Test: A New Era in Screening

The Shield blood test is the culmination of over a decade of research and development by Guardant Health in collaboration with leading global health organizations. Since its introduction in May 2022, the test has demonstrated an impressive adherence rate of over 90%, far surpassing the completion rates of traditional screening methods.

Unlike colonoscopy, which requires special preparation and dietary changes, or stool tests that some find unpleasant, Shield offers a straightforward blood draw during a routine visit. This ease of use is expected to drive higher participation rates in CRC screening.

AmirAli Talasaz, Co-CEO of Guardant Health, expressed enthusiasm about the FDA approval, emphasizing the test’s potential to enhance CRC screening rates and early detection. The FDA’s decision follows a positive recommendation from an Advisory Committee panel and is based on the ECLIPSE study, which involved over 20,000 participants across the U.S. The study confirmed that Shield had 83% sensitivity for CRC detection and 90% specificity for advanced neoplasia.

Expert Opinions

Michael Sapienza, CEO of the Colorectal Cancer Alliance, praised Shield for its accessibility and effectiveness. He noted that the test provides a valuable choice for patients and has the potential to reach underserved communities, significantly advancing the fight against colorectal cancer.

William M. Grady, MD, a gastroenterologist at Fred Hutchinson Cancer Center, highlighted the test’s accuracy and its role as a convenient alternative for those hesitant to undergo traditional screening methods. This new option aligns with efforts to make early detection tools more available and user-friendly.

Real-World Impact

The real-world impact of the Shield test is underscored by patient experiences. Dennis Barnes, a 55-year-old attorney, shared his positive experience with Shield, noting its convenience compared to scheduling a colonoscopy. Similarly, John Gormly, a 77-year-old business executive, credited the test with detecting his stage II colon cancer early, leading to a swift recovery.

Shield is now available through prescription and is expected to be covered for eligible Medicare beneficiaries. Coverage by commercial insurance is anticipated to grow following future guideline endorsements by the American Cancer Society and the U.S. Preventive Services Task Force.