Abbott (NYSE:ABT) has begun rolling out a blood test to help screen for colorectal cancer developed by Freenome, following its approval by the FDA earlier this year.
The SimpleScreen CRC test, for adults 45 and older carrying an average risk for the disease, will be sold exclusively by Abbott alongside the stool-based Cologuard Plus, which it picked up through its $23 billion acquisition of Exact Sciences this past March.
By employing both approaches, Abbott hopes to catch more cases of the third-most diagnosed cancer and the second-leading cause of cancer-related deaths in the U.S.
“More screening options for colorectal cancer only matter if we help more people get screened,” said Jake Orville, senior VP of Abbott’s cancer diagnostics business. “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,” Orville said.
The FDA gave the green light to Freenome’s screener in July, which detects cell-free DNA shed by colorectal tumors into the bloodstream.
In a clinical trial of more than 48,000 asymptomatic participants who also underwent a colonoscopy, SimpleScreen CRC delivered 81.1% sensitivity for colorectal cancer. Precancerous lesions were detected at a lower rate, at 13.7% sensitivity, while lesions displaying advanced growth and high-grade dysplasia recorded 30.7% sensitivity.
According to Abbott, the test is covered by Medicare, with no out-of-pocket costs for eligible patients with Medicare Part B. The company’s patient navigation program will also provide coordination for blood draws as well as screening reminders and follow-up support.
Currently, the American Cancer Society’s recently updated guidelines for colorectal cancer screening say blood-based tests should only be recommended to people who decline or do not complete exams via the preferred methods, including colonoscopy and stool-based tests like Cologuard Plus. Meanwhile, the screening guidelines from the U.S. Preventive Services Task Force were last updated in 2021.
The FDA approved its first blood test for colorectal cancer screening in 2024, with Guardant Health’s Shield. However, as with SimpleScreen CRC, a blood test alone cannot provide a diagnosis; patients with a positive result should schedule a colonoscopy exam.
The ACS estimates that only about 37% of people in the U.S. between ages 45 and 49 have completed the recommended screening regimen, with prevalence rising to 72% between 55 and 59, and 83% in ages 70 to 74.
