Abbott has launched SimpleScreen CRC, an FDA-approved blood-based colorectal cancer screening test in the US.
The commercial launch positions the test as an alternative for patients who decline or do not complete a preferred stool-based (e.g. Cologuard Plus, acquired by Abbott via Exact Sciences) or a direct visual screening test, such as endoscopy.
“We still see too many eligible patients who remain unscreened. Expanding the ways patients can participate in screening gives clinicians another opportunity to address those barriers,” Folasade May, a gastroenterologist and director of quality improvement in gastroenterology at UCLA Health, said in a statement. “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.”
SimpleScreen CRC uses circulating cell-free DNA from blood to detect signals associated with colorectal cancer in adults age 45 and older at average risk for the disease. The test was developed and manufactured by Freenome and is exclusively commercialized by Abbott.
In June, Freenome announced SimpleScreen CRC had met all primary and secondary endpoints in a clinical validation study.
Freenome's Colorectal Cancer Test Hits All Study Endpoints, Triggers $70M Milestone
Freenome said July 9 that its updated SimpleScreen v2 colorectal cancer (CRC) blood test met all primary and secondary endpoints in a pivotal clinical validation study, with the biggest gains coming in detection of precancerous lesions rather than cancer itself.