Dive Brief:
- Abbott said Wednesday it is launching Freenome’s SimpleScreen CRC blood-based test for colorectal cancer in the U.S. as an option for people who decline to complete medical guideline-recommended screening.
- SimpleScreen CRC is an addition to the Cologuard Plus stool-based test in Abbott’s colorectal cancer screening portfolio. Abbott acquired Cologuard in March in the $21 billion buyout of Exact Sciences.
- Freenome developed the SimpleScreen test and manufactures it. Abbott will distribute SimpleScreen in the U.S. under a commercial agreement with Freenome. The test, which won Food and Drug Administration approval this summer, will compete in the market with Guardant Health’s Shield blood test for colorectal cancer screening.
Dive Insight:
The American Cancer Society recommends blood-based tests as a colorectal screening option only for people who are resistant to undergoing a colonoscopy procedure or taking a stool test. Visual exams and stool-based tests are the preferred screening options.
The SimpleScreen test uses circulating cell-free DNA from a blood draw to detect signals associated with colorectal cancer. The test is approved to screen adults age 45 and older who are at average risk for the disease.
Abbott said an analysis of the test showed 81.1% sensitivity for colorectal cancer, meaning SimpleScreen correctly detected about eight in 10 colorectal cancers. Sensitivity for Stage I cancer was 63.5%, while sensitivity for advanced precancerous lesions was 13.7%.
The test correctly produced negative results for nine in 10 people without colorectal cancer or advanced precancerous lesions, the company said.
Abbott said SimpleScreen CRC is covered by Medicare, and eligible patients incur no out-of-pocket costs for the test under Part B coverage.
