ABT · News · 20260930N

Product Launch and Transition

ABBOTT LABORATORIES · 2026-09-30 · Importance 31 · Surprise 42 · In source text

Abbott launched SimpleScreen™ CRC in the United States, an FDA-approved blood-based colorectal cancer screening test for average-risk adults aged 45 and older. The test, developed by Freenome, expands Abbott’s colorectal cancer screening portfolio alongside the Cologuard Plus® stool-based test. SimpleScreen CRC showed 81.1% overall sensitivity for colorectal cancer in clinical trials and is covered by Medicare for eligible patients with Medicare Part B at no out-of-pocket cost. The product targets patients who decline or do not complete colonoscopies or stool-based screening, including an estimated 60 million Americans overdue for colorectal screening.

Key facts

• Abbott announced the U.S. commercial launch of SimpleScreen™ CRC, an FDA-approved blood-based colorectal cancer (CRC) screening test for adults age 45 and older. source
• Abbott announced the U.S. commercial launch of SimpleScreen CRC on Sept. 30, 2026 from Abbott Park, Ill. source
• Abbott launched SimpleScreen CRC, an FDA-approved blood test for colorectal cancer screening in adults aged 45 and older, and the test is covered by Medicare. source
• Abbott is launching Freenome’s SimpleScreen CRC blood-based test for colorectal cancer in the U.S., adding it to its existing portfolio which includes the Cologuard Plus stool-based test. source
• SimpleScreen CRC is covered by Medicare, with no out-of-pocket costs for eligible patients with Medicare Part B. source
• An article states Abbott launched SimpleScreen CRC and that the company offers a combined stool- and blood-based colorectal cancer screening solution, making it the only company to do so. source
• Abbott's SimpleScreen CRC test demonstrated 81.1% overall sensitivity for colorectal cancer in clinical trials. source

Impact estimates