Abbott has launched SimpleScreen CRC, an FDA-approved blood test aimed at expanding colorectal cancer screening options for adults 45 and older at average risk of the disease.

 

The test, developed and manufactured by Freenome and exclusively commercialized by Abbott, joins the company's Cologuard Plus stool-based test in its U.S. colorectal cancer screening portfolio.

 

Abbott said SimpleScreen CRC is designed primarily for eligible patients who decline or do not complete preferred stool-based or visual screening options. The company said the goal is to provide another route to screening for people who might otherwise remain unscreened.

 

The launch comes as colorectal cancer remains the second-leading cause of cancer-related death in the United States. Abbott cited estimates that as many as 60 million Americans remain due for recommended screening.

 

"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," said Folasade May, director of quality in digestive diseases at UCLA Health and co-founder and board member of the Association of Black Gastroenterologists and Hepatologists. 

 

"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. It can help us keep the conversation going and offer another path to screening."

 

SimpleScreen CRC uses circulating cell-free DNA (cfDNA) in blood to detect signals associated with colorectal cancer.

 

Abbott said the test was evaluated in PREEMPT CRC, a prospective clinical validation study involving more than 48,000 asymptomatic, average-risk adults ages 45 to 85 who were scheduled for screening colonoscopy.

 

In a prespecified analysis adjusted to match the U.S. Census, the test showed 81.1% overall sensitivity for colorectal cancer, including 63.5% sensitivity for Stage I disease. It also showed 13.7% sensitivity for advanced precancerous lesions and 90.4% specificity for advanced colorectal neoplasia, according to Abbott.

 

The company said the results mean the test detected roughly eight in 10 colorectal cancers while producing negative results for nine in 10 people without colorectal cancer or advanced precancerous lesions.

 

The American Cancer Society recommends blood-based colorectal cancer screening for eligible people who decline or do not complete a preferred stool-based or visual screening test. A positive blood-test result requires follow-up colonoscopy to complete the screening process.

 

"More screening options for colorectal cancer only matter if we help more people get screened," said Jake Orville, senior vice president of Abbott's cancer diagnostics business. 

 

"Our goal is to help connect each person with an appropriate screening test that is right for them and support them through completion. That means prioritizing the Cologuard Plus test for average-risk patients, colonoscopy for those who need it, and now offering SimpleScreen CRC as a blood-based option for appropriate patients who decline or do not complete a preferred screening test. With our portfolio, Abbott can help healthcare providers and patients prioritize screening and prevention while providing another path to screening for people who might otherwise go unscreened."

 

SimpleScreen CRC is covered by Medicare, with no out-of-pocket costs for eligible patients with Medicare Part B, according to Abbott. Medicare Advantage patients may face out-of-pocket costs.

 

Abbott is also extending its patient-navigation infrastructure to the new test. Support includes blood-draw coordination, patient outreach and reminders, bilingual specialists and translation services, insurance assistance, follow-up support and repeat-screening reminders.

 

Patients can complete the blood draw through mobile phlebotomy at home or at participating laboratories.

 

Abbott said a positive SimpleScreen CRC result should be followed by a timely colonoscopy, consistent with American Cancer Society recommendations.

 

The company described the launch as an expansion of its colorectal cancer screening portfolio, adding a blood-based option for patients who do not complete preferred screening approaches.