Colorectal cancer screening is getting another option for adults who may avoid stool tests or colonoscopy. Abbott has commercially launched SimpleScreen CRC in the United States, an FDA-approved blood test for colorectal cancer (CRC) screening in average-risk adults ages 45 and older. Freenome developed and manufactures the test, while Abbott distributes it exclusively in the U.S.
SimpleScreen CRC adds a blood-based option to Abbott’s screening portfolio, which also includes the stool-based Cologuard Plus test.
A Blood Test for Eligible Adults
Colorectal cancer remains the second-leading cause of cancer-related deaths in the United States. At the same time, an estimated 60 million eligible people have not received recommended screening.
The American Cancer Society (ACS) lists stool-based screening and direct visual examinations as preferred approaches. However, clinical guidelines also recognize blood-based screening for eligible adults who decline or do not complete those methods.
That makes SimpleScreen CRC an additional option for people who remain unscreened after choosing not to use, or failing to complete, a preferred screening method.
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, said in a release:
“We still see too many eligible patients who remain unscreened.”
She added that a blood draw may help some people take action when they have declined another screening method. She also noted that another screening choice can keep the conversation between patients and clinicians moving forward.
How SimpleScreen CRC Works
The test uses a standard blood sample to look for colorectal cancer signals. It analyzes circulating cell-free DNA, which can carry biological information associated with cancer.
Researchers assessed the test in the PREEMPT CRC study. This prospective clinical validation study included more than 48,000 asymptomatic adults between 45 and 85 years old who faced routine screening colonoscopy.
A prespecified analysis adjusted to the U.S. Census population reported the following results:
1. Overall colorectal cancer sensitivity: 81.1%
2. Stage I colorectal cancer sensitivity: 63.5%
3. Sensitivity for advanced precancerous lesions: 13.7%
4. Specificity for advanced colorectal neoplasia: 90.4%
The results indicate that SimpleScreen CRC detected about eight out of every 10 colorectal cancers. It also correctly produced a negative result for about nine out of 10 people without colorectal cancer or advanced precancerous lesions.
Access and Follow-Up
Medicare covers SimpleScreen CRC for eligible Medicare Part B beneficiaries without out-of-pocket costs. However, Medicare Advantage members may have expenses based on their individual plan.
Abbott also plans to connect the test with patient support services. These services can include blood-draw coordination, screening reminders, bilingual outreach, translation, insurance assistance, and tracking for future screening.
Patients may provide samples through mobile phlebotomy at home or participating clinical laboratories.
Jake Orville, senior vice president of Abbott’s cancer diagnostics business, said in a release that screening options matter when they help more people complete testing. He described the intended approach as prioritizing Cologuard Plus for average-risk patients, using colonoscopy when appropriate, and offering SimpleScreen CRC to eligible patients who decline or do not complete a preferred screening test.
A positive SimpleScreen CRC result does not replace diagnostic evaluation. Under ACS recommendations, patients with a positive result should receive a timely follow-up colonoscopy.
SimpleScreen CRC adds a blood-based screening option for eligible adults who do not complete preferred screening methods. The right screening approach depends on a person’s risk, medical history, and clinician’s guidance. A positive result still requires timely follow-up with a colonoscopy.
