FDA approves SimpleScreen™ CRC blood test for colorectal cancer screening in average-risk adults
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The approval provides adults aged 45 years and older at average risk of colorectal cancer with an additional blood-based screening option, expanding access for individuals who are overdue for screening.
The US Food and Drug Administration (FDA) has approved SimpleScreen™ CRC, Freenome's blood-based colorectal cancer screening test, for adults aged 45 years and older who are at average risk of the disease, marking the company's first commercial product.
The approval expands the range of screening options available for eligible patients and may help increase screening uptake among individuals who are reluctant to undergo stool-based testing or colonoscopy, while not replacing established diagnostic pathways.
Field | Content |
Alert Type | Drug Approval |
Drug Name | SimpleScreen™ CRC |
Indication | Blood-based screening for colorectal cancer in adults aged 45 years and older who are at average risk of colorectal cancer. |
Therapy Area(s) | Oncology; Gastroenterology |
Geography | US (FDA) |
What Happened | The FDA approved SimpleScreen™ CRC on 27 July 2026 for colorectal cancer screening in adults aged 45 years and older who are at average risk of the disease. The approval gives Freenome its first FDA-approved commercial product and authorises Abbott, which holds exclusive US commercialisation rights, to launch the blood-based screening test in the US. The approval expands the range of FDA-authorised blood-based colorectal cancer screening options available for average-risk adults. |
Why It Matters | The approval provides clinicians and eligible patients with an additional non-invasive colorectal cancer screening option. While blood-based testing does not replace colonoscopy or other recommended diagnostic pathways, it may improve participation among people who remain unscreened, helping to broaden access to recommended colorectal cancer screening. |
Supporting Context | Colorectal cancer is the second leading cause of cancer-related death in the United States. Freenome estimates that up to 60 million eligible Americans are overdue for colorectal cancer screening, highlighting the need for additional screening options. |
Key Takeaway | FDA approval of SimpleScreen™ CRC expands the range of blood-based colorectal cancer screening options available for average-risk adults aged 45 years and older. |
What to Watch | Abbott plans to commercially launch SimpleScreen™ CRC in the United States during autumn 2026. Uptake, reimbursement and future updates to clinical screening recommendations will be important to monitor. |
Primary Source | |
Relevant Date | 27 July 2026 |
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