The US Food and Drug Administration approved SimpleScreen CRC, a blood-based colorectal cancer screening test for adults aged 45 and older who are at average risk, according to a July 27, 2026 announcement reported by MedPage Today. July 27, 2026 is the date of the approval, not the publication date of this report. [Source 15031]
Developed by Freenome, SimpleScreen CRC analyzes cell-free DNA in a blood sample for signals associated with colorectal cancer. It joins Guardant Health’s Shield as an FDA-approved blood-based option for colorectal cancer screening. The test is intended to broaden the ways eligible adults can be screened, particularly when they are unable or unwilling to complete another established method. [Source 15031]
The approval was supported by results from PREEMPT CRC, a study conducted at more than 200 sites. The trial enrolled over 48,000 asymptomatic adults between 45 and 85 years old who were considered at average risk and were already scheduled to undergo a screening colonoscopy. [Source 15031]
In a prespecified analysis adjusted to reflect the US Census, SimpleScreen CRC had 81.1% sensitivity for colorectal cancer, meaning it identified that proportion of cancers in the analysis. Its sensitivity for advanced precancerous lesions was 13.7%, rising to 30.7% among lesions with high-grade dysplasia. The test recorded 90.4% specificity for advanced colorectal neoplasia. These figures show that its performance differs between detecting cancer and finding advanced lesions that may precede cancer. [Source 15031]
A positive blood-test result means that an associated signal was detected and may indicate colorectal cancer or an advanced precancerous lesion. It does not establish a diagnosis. Patients with positive results should proceed to colonoscopy for further assessment, according to information from the company cited by MedPage Today. SimpleScreen CRC is also not a substitute for diagnostic colonoscopy or the surveillance colonoscopies recommended for people at high risk. [Source 15031]
The approval adds convenience but does not place blood testing ahead of other screening approaches. MedPage Today reported that updated American Cancer Society guidelines do not recommend blood-based tests as a preferred option. The guidelines allow them to be offered when an individual declines or cannot complete a preferred screening test. [Source 15031]
Colorectal cancer is the second-leading cause of cancer-related death in the United States, while detection at an early stage can make the disease more preventable and treatable. Freenome estimated that as many as 60 million Americans are overdue for recommended screening. The company also said SimpleScreen CRC meets Medicare coverage criteria, potentially expanding access among eligible adults. [Source 15031]
The new test therefore provides an additional route into screening rather than replacing colonoscopy or other preferred methods. Its practical effect will depend on whether greater convenience encourages more eligible adults to be screened and whether patients with positive findings complete the necessary colonoscopy.
