Blood-Based Test Broadens Colorectal Cancer Screening Options

Colorectal cancer is the second-leading cause of cancer-related death in the U.S., yet outcomes improve markedly when the disease is detected through routine screening. Despite this, up to 60 million Americans remain due for recommended screening, underscoring persistent barriers to test completion among average‑risk adults ages 45 and older. Expanding noninvasive options that fit patients’ preferences may help close these gaps. A newly launched blood-based test now adds another pathway to screening for people who decline or do not complete preferred approaches.

SimpleScreen CRC is an FDA‑approved blood‑based colorectal cancer (CRC) screening test for adults 45 and older at average risk. Developed and manufactured by Freenome and exclusively commercialized by Abbott, it joins the Cologuard Plus test in Abbott’s screening portfolio, which now spans both stool‑ and blood‑based options. 

Image: Developed and manufactured by Freenome and exclusively commercialized by Abbott, SimpleScreen CRC joins the Cologuard Plus test in Abbott’s screening portfolio, which now spans both stool‑ and blood‑based options (Photo courtesy of Freenome)

The assay detects signals associated with CRC by analyzing circulating cell‑free DNA (cfDNA) obtained from a routine blood draw. In alignment with American Cancer Society (ACS) recommendations cited in the launch, blood‑based screening is intended for individuals who decline or do not complete preferred stool‑based or direct visual tests. Within that context, SimpleScreen CRC offers a convenient alternative that can be ordered and completed through standard phlebotomy.

Clinical validation was conducted in PREEMPT CRC, described as the largest prospective clinical validation study for a blood‑based CRC screening test. The study enrolled more than 48,000 asymptomatic, average‑risk adults ages 45–85 who were scheduled for screening colonoscopy. 

In a prespecified analysis adjusted to match the U.S. Census, SimpleScreen CRC achieved 81.1% overall sensitivity for CRC, including 63.5% for Stage I disease; 13.7% sensitivity for advanced precancerous lesions; and 90.4% specificity for advanced colorectal neoplasia.

The launch extends an established patient‑navigation model to support test completion, including blood‑draw coordination, outreach and reminders, bilingual assistance and translation services, insurance support, and follow‑up and repeat‑screening reminders. Blood draws can be performed at home through mobile phlebotomy or at participating laboratories. A positive SimpleScreen CRC result should be followed by a timely colonoscopy to complete the screening process, consistent with ACS guidance.

“We still see too many eligible patients who remain unscreened. Expanding the ways patients can participate in screening gives clinicians another opportunity to address those barriers. For someone who has declined or does not complete preferred approaches, the option of a blood draw may be what helps them finally take action. It can help us keep the conversation going and offer another path to screening,” said Dr. Folasade May, director of quality in digestive diseases at UCLA Health and co-founder and board member of the Association of Black Gastroenterologists and Hepatologists.