Abbott is kickstarting the U.S. commercial launch of SimpleScreen CRC, an FDA-approved blood-based colorectal cancer (CRC) screening test for adults age 45 and older who are at average risk for the disease.
Developed and manufactured by Freenome and exclusively sold by Abbott, the Cologuard Plus test is the latest addition to Abbott's colorectal cancer screening portfolio.
The product launch comes after Abbot’s acquisition of Exact Sciences earlier this year, and is the only test that provides both stool and blood-based colorectal cancer screening options.
Colorectal cancer’s devastating impact among adults aged younger than 50 has become increasingly visible over social media and through highly publicised news coverage in recent years.
Cancer researchers acknowledge that more younger people are being diagnosed with CRC but have not yet determined why. While it’s currently the second-leading cause of cancer-related death in the U.S., it is preventable and highly treatable when detected early through screening.
In 2025, the CDC estimated 28 million Americans aged between 45 and 75 have never been screened for colorectal cancer.
Cologuard Plus is an American Cancer Society (ACS)-preferred stool-based screening option for eligible adults who decline or do not complete preferred colonoscopy screenings alongside other visual exams, including CT colonography and sigmoidoscopy.
While colonoscopy testing remains the most reliable way to screen for colorectal cancer, SimpleScreen CRC is designed to help diagnose those who are unwilling or unable to undergo the procedure.
"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," 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, in a statement.
"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."
The ACS recommends several preferred CRC screening options, including stool-based tests and direct visual tests. All blood-based screening should be recommended only for individuals who decline or do not complete a preferred screening option, says Abbott. For those patients, SimpleScreen CRC provides a convenient way to get screened through a simple blood draw.
"More screening options for colorectal cancer only matter if we help more people get screened," said Jake Orville, senior vice president of Abbott's cancer diagnostics business, in a release.
"Our goal is to help connect each person with an appropriate screening test that is right for them and support them through completion. That means prioritizing the Cologuard Plus test for average-risk patients, colonoscopy for those who need it, and now offering SimpleScreen CRC as a blood-based option for appropriate patients who decline or do not complete a preferred screening test.”
SimpleScreen CRC detects signals associated with colorectal cancer by monitoring circulating cell-free DNA (cfDNA) in blood. The test was evaluated in PREEMPT CRC in the largest prospective clinical validation study conducted to date for a blood-based colorectal cancer screening test. The study enrolled more than 48,000 asymptomatic, average-risk adults ages 45 to 85 who were scheduled for screening colonoscopy.
In a prespecified analysis adjusted to match the U.S. Census, SimpleScreen CRC demonstrated 81.1% overall sensitivity for colorectal cancer, including 63.5% sensitivity for Stage I CRC; 13.7% sensitivity for advanced precancerous lesions; and 90.4% specificity for advanced colorectal neoplasia.
The test correctly detected about eight in 10 colorectal cancers while correctly producing negative results for nine in 10 people without colorectal cancer or advanced precancerous lesions.