FDA Approves SimpleScreen CRC Blood Test for Colorectal Cancer Screening

A new blood-based colorectal cancer (CRC) screening option may help engage adults who have not completed recommended screening, although its limited detection of precancerous lesions reinforces the need for careful patient counseling and appropriate follow-up. CRC remains the second-leading cause of cancer-related death in the United States, despite being highly preventable and treatable when detected early. With up to 60 million Americans overdue for screening, additional testing options could help address persistent barriers to participation.¹

Freenome and Abbott announced that the FDA has approved SimpleScreen CRC for adults aged 45 and older who are at average risk for CRC and have been referred by a clinician for screening. The test uses a routine blood draw to identify CRC-associated methylation signals in cell-free DNA. Abbott plans to exclusively commercialize the test in the United States beginning in fall 2026.¹

PREEMPT CRC Establishes Clinical Performance

The approval was supported by data from PREEMPT CRC (NCT04369053), a prospective, multicenter, cross-sectional study that enrolled more than 48,000 asymptomatic adults aged 45 to 85 years who were at average risk and planned to undergo screening colonoscopy.^1,2

In published findings from the analysis, the investigational blood test demonstrated 79.2% sensitivity for CRC and 91.5% specificity for advanced colorectal neoplasia. Sensitivity for advanced precancerous lesions was 12.5% and did not meet the prespecified acceptance criterion.² For the US Census–adjusted analysis supporting the commercial test, Freenome reported 81.1% sensitivity for CRC, 13.7% sensitivity for advanced precancerous lesions, and 90.4% specificity for advanced colorectal neoplasia. Sensitivity reached 30.7% for advanced precancerous lesions with high-grade dysplasia.¹

These findings suggest that SimpleScreen CRC can identify approximately 8 of 10 existing cancers while correctly returning a negative result for an estimated 9 of 10 individuals without CRC or an advanced precancerous lesion. However, the low sensitivity for advanced precancerous lesions remains clinically important because detecting and removing these lesions is central to preventing CRC.¹

Guidelines Position Blood Testing as a Secondary Option

The American Cancer Society (ACS) recommends that adults at average risk begin CRC screening at age 45 years. Its 2026 guideline includes blood-based testing among available strategies but continues to prefer stool-based tests and visual examinations. Additionally, the ACS advises reserving blood-based tests for patients who are unwilling or unable to complete a preferred option, in part because blood tests are less likely to detect precancerous growths and stage I disease. Any positive noncolonoscopy test requires a timely diagnostic colonoscopy.³

SimpleScreen CRC is not intended to replace diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. A positive result indicates that a signal associated with CRC or an advanced precancerous lesion was detected and should prompt a subsequent colonoscopy.¹

Access and the Pharmacist’s Role

Current Medicare policy covers eligible noninvasive biomarker CRC screening tests once every 3 years for asymptomatic, average-risk beneficiaries aged 45 to 85 years when specific ordering, FDA authorization, laboratory, and follow-up criteria are met. The policy also requires that patients receive information about test performance and the importance of colonoscopy after a positive result.⁴

Pharmacists can reinforce age- and risk-appropriate screening, explain that a negative blood test does not eliminate future screening needs, and help patients understand that convenience must be paired with follow-through testing or procedures. They can also identify patients who may require a preferred test due to symptoms, family history, or other high-risk factors. By identifying overdue patients and emphasizing timely colonoscopy after a positive result, pharmacists can help translate an expanded menu of screening options into completed screening and earlier detection.

REFERENCES

1. FDA approves Freenome’s SimpleScreen CRC blood-based screening test; Abbott to commercialize in the US. News release. Freenome, Inc. July 27, 2026. Accessed July 28, 2026. https://www.freenome.com/newsroom/fda-approves-freenomes-simplescreen-crc/

2. Shaukat A, Burke CA, Chan AT, et al. Clinical validation of a circulating tumor DNA-based blood test to screen for colorectal cancer. JAMA. 2025;334(1):56-63. doi:10.1001/jama.2025.7515

3. Wolf AMD, Hoffman RM, Walter LC, et al. Colorectal cancer screening: an update to the American Cancer Society guideline, 2026. CA Cancer J Clin. 2026;76(3):e70083. doi:10.3322/caac.70083

4. Screening for colorectal cancer—non-invasive biomarker tests. Centers for Medicare & Medicaid Services. Accessed July 28, 2026. https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?NCAId=319&proposed=N