Guardant Health’s Shield
There is more good news for cancer treatment, where early detection is one of the most important factors in success. A blood test from Guardant Health for colorectal cancer (CRC) screening in adults age 45 and older who are at average risk for the disease called “Shield” was approved by the FDA.
Guardant Health said Shield is the first blood test to be approved by the FDA as a primary screening option for CRC, meaning healthcare providers can offer Shield in a manner similar to all other non-invasive methods recommended in screening guidelines. Shield is also the first blood test for CRC screening that meets the requirements for Medicare coverage.
Colorectal cancer is a serious health threat in the United States. Despite being highly treatable when detected early, it remains the second leading cause of cancer-related deaths. The American Cancer Society predicts over 150,000 new cases in 2024 alone, with more than 53,000 fatalities. Alarmingly, over 75% of these deaths occur in individuals who haven’t undergone recommended screenings. Early detection is crucial; survival rates soar to 91% when cancer is caught in its initial stages, compared to a stark 14% when it spreads.
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The U.S. is falling short in colorectal cancer prevention. Despite the availability of effective screening tests, only about 59% of eligible Americans are up-to-date with their screenings. This significantly lags behind the National Colorectal Cancer Roundtable’s ambitious goal of 80% screening rates. Over 50 million Americans are at risk due to misconceptions about the screening process, often perceiving it as invasive or inconvenient.
“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.”
The FDA decision follows a strong recommendation for approval by an Advisory Committee panel in May 2024. The approval was based on results of ECLIPSE , a 20,000+-patient registrational study evaluating the performance of the test for detecting CRC in average-risk adults. Designed to reflect the diverse population of the U.S., the study was conducted at more than 200 clinical trial sites in rural and urban communities across 37 states. Results from the study, published in the March 14, 2024, issue of The New England Journal of Medicine , showed that Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. This performance is within range of current guideline-recommended non-invasive screening methods, in which overall CRC sensitivity ranges from 74% to 92%.
