FDA Approves First Blood Test for Early Detection and Screening of Colorectal Cancer

The FDA has approved the first blood test as a primary screening option for colorectal cancer. This non-invasive method simplifies the process with a quick blood draw, representing a significant advancement in colorectal cancer detection and could revolutionize access to early treatment.

Guardant Health announced that the U.S. Food and Drug Administration (FDA) has approved the first DNA-based blood test, Shield, as a primary screening option for colorectal cancer in adults aged 45 and older. This landmark approval not only introduces a novel method for early detection but also heralds a significant shift toward increasing patients' chances of accessing treatment options and reducing mortality rates.

The approval of Shield is based on the results from the ECLIPSE study, involving over 20,000 patients across the U.S. This large-scale study showcased Shield’s effectiveness, demonstrating 83% sensitivity in detecting colorectal cancer and 90% specificity for advanced neoplasia. These figures are comparable to those of existing non-invasive methods, which have sensitivities ranging from 74% to 92%.

Colorectal cancer is the second-leading cause of cancer-related deaths in the U.S., with over 150,000 new cases and 53,000 deaths expected in 2024. Screening rates are low at 59%, well below the target, due to the invasive and inconvenient nature of traditional methods like colonoscopies and stool tests.

The new DNA-based test, addresses these barriers by offering a simple blood draw option, which can be done during a routine healthcare visit without the need for special preparation. This ease of use has shown to significantly improve adherence, with real-world data indicating a completion rate of over 90%, a stark contrast to the 28-71% completion rate for other screening methods.

Dr. Daniel Chung, MD, from Massachusetts General Hospital, emphasized the potential of the new test to transform the colorectal cancer screening landscape. “The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people. The FDA's approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap,” said Dr. Chung.

The FDA’s decision was influenced by the strong recommendation of an advisory committee in May 2024 and the test’s proven performance metrics. Following FDA approval, Shield is now set to be a major player in the future of colorectal cancer prevention, with Medicare coverage ensuring accessibility for a broad segment of the population.

“The FDA approval of the Shield test is a significant victory for patients and an important milestone in Guardant Health’s mission to conquer cancer with data. Shield can help improve colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable,” said AmirAli Talasaz, Guardant Health co-CEO. “We are now getting ready to launch this test in the near future and are very excited to empower physicians with a viable blood-based screening option to tailor the screening regimen to the unique needs of their patients.”