Colon Cancer Blood Test Approved by the FDA

Guardant Health has recently announced that its Shield blood test has been approved by the FDA as a new way to screen and look for signs of colorectal cancer (CRC) in adults aged 45 and older who are at average risk. This marks a medical milestone as being the first-ever blood test to be granted the FDA’s approval.

The Guardant Shield test will be a noninvasive, convenient alternative to the more commonly performed methods like colonoscopy. Colonoscopies are generally unpleasant for most, and that remains a reason many avoid having the procedure performed. This new blood test is expected to improve screening rates, which currently stand at only 59% in the U.S., well below the National Colorectal Cancer Roundtable’s goal of 80%.

“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. 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.”

AmirAli Talasaz, Guardant Health co-CEO via Guardant Health Press Release

Colorectal cancer remains a leading cause of cancer-related deaths in the U.S., but early detection significantly boosts survival rates for those diagnosed. Shield, with a demonstrated 83% sensitivity for CRC detection and 90% specificity for advanced neoplasia, has shown high patient adherence since its introduction in May 2022. This new test also meets Medicare coverage requirements.

According to the Associated Press, the test detects DNA fragments released by tumor cells and precancerous growths. A study published in March identified 83% of cancers using this test but detected very few of the precancerous growths with a colonoscopy, which is considered the “gold standard for colon cancer screening.” The test failed to identify 17% of cancers, a performance level similar to that of stool-based tests.

Guardant Health plans to launch Shield soon and will discuss the approval in an investor conference call on July 29, 2024. The test, available by prescription, is expected to be covered for Medicare beneficiaries and potentially for those with commercial insurance as guidelines evolve.