NEW YORK – Guardant Health said Tuesday that it has partnered with Ohio State University Comprehensive Cancer Center to evaluate patient compliance with blood-based colorectal cancer screening using the company's Shield assay.
In the Guardant-funded, investigator-initiated study, OSU will enroll approximately 300 individuals aged 45 years and older from minority and underserved populations via mobile health clinics, where they will be given the option to have the Shield test. Investigators plan to interview these subjects to evaluate attitudes and beliefs about colorectal cancer screening, and to evaluate the rate of screening acceptance in this population.
The company's ECLIPSE study demonstrated 83 percent sensitivity and 90 percent specificity for the assay in detecting colorectal tumors later confirmed by colonoscopy.
According to Guardant, the Appalachian region has higher than average incidence and mortality rates for colorectal cancer. The company believes that the Shield test can remove barriers associated with existing CRC screening methods, which include colonoscopy and stool-based laboratory tests. The firm cites patient adherence of approximately 90 percent since the test's clinical launch last year.
A similar study is also taking place in collaboration with the University of Chicago, and Guardant recently announced that it has submitted the final module of its premarket approval application for the test to the US Food and Drug Administration.