FDA Approves Blood Test as Primary Screening Option for Colorectal Cancer

The FDA has approved Guardant Health’s Shield blood test as a primary screening option for colorectal cancer. Guardant's website has the release.

The test has specifically been approved for “adults age 45 and older who are at average risk for the disease. It 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.”

The American Cancer Society estimates that “more than 150,000 people will be diagnosed with CRC in 2024 and the disease will be responsible for more than 53,000 deaths. More than three out of four individuals who die from CRC are not up to date with their screening.” Five-year relative survival rate for colon cancer found at an early stage is 91%, but the rate drops all the way down to 14% if the cancer has spread.

In the U.S., 59% of eligible adults are screened for colon cancer, falling well short of the 80% goal of the Colorectal Cancer Roundtable. More than “one out of three eligible Americans – over 50 million people – do not complete CRC screening, often due to the perception that other available options, such as colonoscopy or stool-based tests, are invasive, unpleasant or inconvenient.”

The Shield test saw adherence rates of over 90% since the laboratory developed test was introduced in May 2022, whereas only 28-71% of patients prescribed other screening methods, such as colonoscopy or a stool test, complete them. 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%.”