Abbott launches SimpleScreen CRC blood test for colorectal cancer screening

Abbott has launched SimpleScreen CRC in the U.S., expanding its colorectal cancer screening portfolio with an FDA approved blood test for adults aged 45 years and older who are at average risk of the disease.

The test was developed and manufactured by Freenome and will be commercialised exclusively by Abbott.

SimpleScreen CRC joins Abbott’s Cologuard Plus stool screening test, giving healthcare professionals access to both blood and stool based approaches for eligible patients.

Abbott said the new test is intended particularly for people who decline or do not complete preferred colorectal cancer screening methods.

SimpleScreen CRC uses circulating cell free DNA found in the blood to detect biological signals associated with colorectal cancer.

The test was clinically validated in PREEMPT CRC, a prospective study involving more than 48,000 asymptomatic adults aged 45 to 85 who were considered at average risk and were scheduled to undergo screening colonoscopy.

In a prespecified analysis adjusted to reflect the U.S. Census population, SimpleScreen CRC achieved an overall colorectal cancer sensitivity of 81.1%.

Sensitivity for Stage I colorectal cancer was 63.5%, while sensitivity for advanced precancerous lesions was 13.7%.

Specificity for advanced colorectal neoplasia reached 90.4%.

Abbott said this means the test identified approximately eight out of every 10 colorectal cancers while correctly returning negative results in around nine out of 10 people without colorectal cancer or advanced precancerous lesions.

Folasade May, MD, Director of Quality in Digestive Diseases at UCLA Health, said a significant number of people who are eligible for colorectal cancer screening still do not complete recommended testing.

She said offering a blood draw may provide another route to screening for patients who have declined or have not completed other approaches.

The American Cancer Society recommends several preferred colorectal cancer screening methods, including stool tests and direct visual examinations.

Blood based screening is recommended as an alternative for eligible individuals who decline or fail to complete one of these preferred options.

Jake Orville, Senior Vice President of Abbott’s cancer diagnostics business, said expanding the number of available screening methods could help healthcare professionals match more patients with an appropriate testing approach.

He said Abbott will continue to prioritise Cologuard Plus for eligible average risk patients and colonoscopy where appropriate, while SimpleScreen CRC provides another option for those who might otherwise remain unscreened.

SimpleScreen CRC is covered by Medicare, with eligible Medicare Part B patients having no out of pocket costs. Patients enrolled in Medicare Advantage plans may still face some personal costs.

Abbott is also extending its patient navigation infrastructure to support people using SimpleScreen CRC.

Services include assistance arranging blood collection, patient reminders, bilingual support, translation services, insurance assistance, follow up and repeat screening reminders.

Patients can complete the required blood draw through participating laboratories or, where available, mobile phlebotomy at home.

A positive SimpleScreen CRC result should be followed by colonoscopy to complete the screening process.

Abbott said the addition of SimpleScreen CRC gives it a broader colorectal cancer screening portfolio aimed at improving access to early detection for eligible patients.

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