The FDA-approved blood-based test expands colorectal cancer screening options for average-risk adults 45 and older and is covered by Medicare for eligible beneficiaries.
Abbott has commercially launched SimpleScreen CRC in the US, an FDA-approved blood-based colorectal cancer (CRC) screening test for average-risk adults aged 45 and older. Developed and manufactured by Freenome and commercialized exclusively by Abbott, the test joins the stool-based Cologuard Plus test in the company’s CRC screening portfolio.
Colorectal cancer represents the second-leading cause of cancer-related mortality in the US, with an estimated 60 million eligible individuals remaining unscreened. While the American Cancer Society (ACS) recommends stool-based tests and direct visual examinations as preferred screening options, clinical guidelines recommend blood-based screening for eligible adults who decline or fail to complete those preferred methods. SimpleScreen CRC is designed to serve as an alternative pathway for this unscreened population.
“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,” says Folasade May, MD, PhD, MPhil, 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 release. “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.”
Clinical Validation and Test Performance
SimpleScreen CRC detects colorectal cancer signals by analyzing circulating cell-free DNA from a standard blood draw. The assay was evaluated in the PREEMPT CRC study, a prospective clinical validation study that enrolled more than 48,000 asymptomatic, average-risk individuals aged 45 to 85 scheduled for routine screening colonoscopy.
In a prespecified analysis adjusted to the US Census population, the test demonstrated:
- 81.1% overall sensitivity for colorectal cancer
- 63.5% sensitivity for Stage I CRC
- 13.7% sensitivity for advanced precancerous lesions
- 90.4% specificity for advanced colorectal neoplasia
The test correctly identified approximately eight in 10 colorectal cancers while correctly returning negative findings for nine in 10 individuals without colorectal cancer or advanced precancerous lesions.
“More screening options for colorectal cancer only matter if we help more people get screened,” says 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.”
Laboratory Access and Patient Navigation
SimpleScreen CRC is covered under Medicare, with no out-of-pocket costs for eligible Medicare Part B beneficiaries; Medicare Advantage patients may be subject to out-of-pocket expenses depending on plan coverage.
Abbott is integrating the test into its existing patient navigation infrastructure to assist patients from test order through completion. Support services include blood-draw coordination, screening reminders, bilingual outreach, translation services, insurance navigation, and repeat-screening tracking. Patients can complete sample collection through mobile phlebotomy at home or at participating clinical laboratories.
In accordance with ACS recommendations, patients who receive a positive SimpleScreen CRC result require a timely follow-up colonoscopy to complete the diagnostic evaluation.
ID 177166508 | Abbott © Michaelvi | Dreamstime.com
