Abbott Announces U.S. Launch of SimpleScreen CRC Blood Test for Colorectal Cancer Screening
Abbott has announced the U.S. commercial launch of SimpleScreen CRC, an FDA-approved blood-based colorectal cancer screening test for adults age 45 and older who are at average risk for the disease. Developed and manufactured by Freenome and exclusively commercialized by Abbott, the test joins Cologuard Plus in Abbott’s colorectal cancer screening portfolio, providing another way to help reach people who otherwise may remain unscreened.
Colorectal cancer is the second-leading cause of cancer-related death in the U.S., yet it is preventable and highly treatable when detected early through screening. Up to 60 million Americans remain due for recommended screening. With Cologuard Plus, an American Cancer Society-preferred stool-based option, and SimpleScreen CRC, a blood-based option for eligible adults who decline or do not complete preferred screening, Abbott provides tests that help healthcare providers match more patients with an appropriate screening option while keeping prevention and early detection at the forefront.
SimpleScreen CRC detects signals associated with colorectal cancer using circulating cell-free DNA in the blood. The test was evaluated in PREEMPT CRC, the largest prospective clinical validation study conducted for a blood-based colorectal cancer screening test, which enrolled more than 48,000 asymptomatic, average-risk adults ages 45 to 85 scheduled for screening colonoscopy. In a prespecified analysis adjusted to match the U.S. Census, the test 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. SimpleScreen CRC is covered by Medicare, with no out-of-pocket costs for eligible patients with Medicare Part B.
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, said too many eligible patients remain unscreened, and expanding the ways patients can participate in screening gives clinicians another opportunity to address those barriers. May noted that 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, helping keep the conversation going and offering another path to screening.
Jake Orville, Senior Vice President of Abbott’s cancer diagnostics business, said more screening options for colorectal cancer only matter if they help more people get screened. Orville noted that the company’s goal is to help connect each person with an appropriate screening test and support them through completion, which 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.
With SimpleScreen CRC, Abbott is extending the patient support infrastructure built through Cologuard to help eligible patients move from an order to a completed test. The test is backed by Abbott’s patient navigation program, including blood-draw coordination, patient outreach and screening reminders, bilingual specialists and translation services, insurance assistance, follow-up support, and repeat-screening reminders. Patients have flexible options for completing their blood draw, including at home through mobile phlebotomy or at a participating lab. A patient with a positive result should receive a timely follow-up colonoscopy to complete the screening process, consistent with American Cancer Society recommendations.
