The U.S. Food and Drug Administration has cleared SimpleScreen, a blood-based test from California biotechnology company Freenome, for colorectal cancer screening in average-risk adults aged 45 and older. The test analyzes circulating DNA signals associated with colorectal cancer and returns results within about two weeks after a routine blood draw.
How the Test Was Evaluated
In the largest study of its kind to date, researchers enrolled more than 48,000 average-risk adults aged 45–85 who were scheduled for screening colonoscopy. SimpleScreen detected roughly eight in 10 colorectal cancers and correctly returned negative results for about nine in 10 people without colorectal cancer or advanced precancerous lesions. A positive SimpleScreen result should be followed by diagnostic colonoscopy to confirm the presence of cancer or advanced precancerous polyps.
Colorectal cancer is one of the deadliest cancers in America. A new, non-invasive blood test could help more people get screened for the disease (Getty Images for Fight Colorecta)
Context and Comparison
SimpleScreen is the second FDA-cleared blood test for colorectal cancer screening, following Guardant Health’s Shield test, cleared in 2024. Clinical data for Shield also showed detection of more than eight in 10 colorectal cancers overall, though some analyses indicated lower sensitivity for Stage 1 disease. Experts caution that head-to-head comparisons between tests require further study.
“Many people who should be screened for colorectal cancer simply aren't,” said Dr. Aasma Shaukat, co-lead investigator on the SimpleScreen study and professor of medicine at NYU Grossman School of Medicine. “A blood-based test provides another way to reach unscreened patients, and bringing more people into the screening fold leads to earlier detection and better outcomes.”
Availability and Cost
Freenome says SimpleScreen is expected to be offered to patients this fall in partnership with Abbott, an Illinois-based healthcare company. Pricing for SimpleScreen has not yet been announced. For comparison, Guardant’s Shield is available at no cost to patients with Medicare Part B, while patients without Medicare may face out-of-pocket costs up to $1,495.
By 2030, colorectal cancer is predicted to be a leading cause of cancer death for people under 50 and more than 55,000 deaths are projected this year (Getty Images)
Why This Matters
Colorectal cancer remains one of the leading causes of cancer deaths in the United States. Incidence has been rising among younger adults for reasons that may include diet, changes in the gut microbiome, environmental factors and shifting screening recommendations—the U.S. Preventive Services Task Force lowered the recommended starting age to 45 in 2021. Experts emphasize that blood-based tests are screening tools, not diagnostic tests, and positive results require follow-up colonoscopy.
Bottom line: SimpleScreen adds a noninvasive option that could increase screening uptake, but clinicians and patients should weigh test performance, availability, cost, and the need for confirmatory colonoscopy when choosing a screening strategy.
