The July 2026 approval follows the 2024 clearance of Guardant Health’s Shield test and adds another tool to a screening landscape where colonoscopy and stool-based tests have long dominated. In the PREEMPT CRC trial of more than 48,000 participants, SimpleScreen correctly identified roughly 8 in 10 colorectal cancers and returned negative results for about 9 in 10 people without cancer or advanced precancerous lesions.
Why a Blood Test Matters Now
Colorectal cancer is the second leading cause of cancer-related deaths worldwide, and early-onset colorectal cancer has become the leading cause of cancer-related death among adults under 50. Current guidelines recommend that average-risk adults 45 and older undergo regular screening, yet participation lags far behind.
Barriers to screening include preparation demands, discomfort, embarrassment, time away from work, cost, limited healthcare access, and a tendency to delay preventive care when no symptoms are present. Some people also view screening as stigmatized. No single method has been able to overcome all of these obstacles.
Blood-based screening aims to meet people where they are. A simple blood draw, processed in a laboratory for specific DNA changes associated with cancer, requires no bowel preparation and no home stool collection. Results are typically available within about two weeks, with a positive result requiring a follow-up colonoscopy.
How SimpleScreen Detects Cancer Signals
SimpleScreen works by detecting patterns of cytosine-phosphate-guanine (CpG) methylation — epigenetic changes that often occur early in cancer development. These methylation signals serve as biomarkers that can flag colorectal cancer or precancerous cells before symptoms appear.
Paul Limburg, MD, MPH, Chief Screening Medical Officer at Abbott Cancer Diagnostics, told Medical News Today that colorectal cancer screening is “not one-size-fits-all” and that patient preferences vary widely. “The current American Cancer Society guideline identifies stool-based testing, including the Cologuard Plus test, and visual examinations such as colonoscopy as preferred screening options,” Limburg said.
Earlier research found that most people prefer stool-based screening to colonoscopy. More recent evidence suggests many would prefer blood-based screening over both, which may improve colorectal cancer screening uptake — particularly among those who are unscreened or overdue.
Where Blood Tests Fit in the Screening Hierarchy
The American Gastroenterological Association and the American Society for Gastrointestinal Endoscopy both acknowledge that blood tests could increase participation, especially among people who decline other methods. Both organizations conclude, however, that current blood-based tests are less effective than established options and should generally be reserved for individuals unwilling to undergo colonoscopy or stool-based testing.
“With the addition of the SimpleScreen CRC test, healthcare providers have another option for eligible patients who may decline or not complete a guideline-preferred screening test, creating more opportunities to engage people who otherwise might not get screened,” Limburg said.
Research suggests adherence to blood-based screening could reach 95% in real-world settings, particularly when the test is free or covered by insurance. That uptake advantage matters because the most effective screening test, clinicians repeatedly emphasize, is the one a patient actually completes.
What Happens Next
The American Cancer Society recently updated its colorectal cancer screening guideline for average-risk individuals to include blood-based screening tests for those who decline or do not complete a preferred option. Insurers and Medicare will now face decisions about coverage for SimpleScreen, which will shape how widely the test reaches the 60 million unscreened Americans.
Watch for real-world adherence data as SimpleScreen enters clinical use, alongside head-to-head comparisons with Shield. If blood-based screening uptake matches early projections, the colorectal cancer screening gap — and the mortality that follows from late detection — could narrow significantly. Clinicians stress, however, that blood tests complement rather than replace colonoscopy, which remains the gold standard for both detection and removal of precancerous lesions.
— Aisha Mensah, health desk, AXO News