Abbott has announced the US commercial launch of SimpleScreen CRC, an FDA-approved blood-based Colorectal Cancer (CRC) screening test for adults aged 45 and older who are at average risk of the disease. Developed and manufactured by Freenome and exclusively commercialised by Abbott, the test adds a blood-based option to Abbott’s colorectal cancer screening portfolio alongside the Cologuard Plus test.

Colorectal cancer is the second-leading cause of cancer-related deaths in the US, while early detection through screening can improve treatment outcomes. Abbott said up to 60 million Americans remain due for recommended CRC screening, highlighting the need for additional screening approaches for eligible individuals.

The American Cancer Society (ACS) recommends several preferred CRC screening methods, including stool-based tests and direct visual examinations. Blood-based screening is recommended for eligible individuals who decline or do not complete a preferred screening option. SimpleScreen CRC is intended for this patient population and requires a simple blood draw.

SimpleScreen CRC detects signals associated with colorectal cancer using circulating cell-free DNA (cfDNA) in blood. The test was evaluated in the PREEMPT CRC study, a prospective clinical validation study involving more than 48,000 asymptomatic, average-risk adults aged 45 to 85 who were scheduled for screening colonoscopy.

In a prespecified analysis adjusted to the US Census, SimpleScreen CRC demonstrated 81.1 percent overall sensitivity for colorectal cancer, including 63.5 percent sensitivity for Stage I CRC. The test also showed 13.7 percent sensitivity for advanced precancerous lesions and 90.4 percent specificity for advanced colorectal neoplasia.

The test is covered by Medicare, with eligible patients with Medicare Part B having no out-of-pocket costs. Medicare Advantage patients may have out-of-pocket costs.

Abbott is also providing patient support services to assist eligible individuals throughout the screening process. These services include blood-draw coordination, patient outreach and reminders, bilingual support and translation services, insurance assistance, follow-up support and repeat-screening reminders.

Patients can complete their blood draw through mobile phlebotomy at home or at participating laboratories. Abbott said the support infrastructure is intended to help patients progress from test ordering to completion and understand subsequent steps.

A positive SimpleScreen CRC result should be followed by a timely colonoscopy to complete the screening process, consistent with ACS recommendations.

The launch expands Abbott’s colorectal cancer screening portfolio, providing healthcare providers with an additional screening option for eligible average-risk adults who do not complete preferred screening approaches.