Abbott has commercially rolled out SimpleScreen CRC in the US, introducing a blood test approved by the Food and Drug Administration (FDA) for colorectal cancer screening.
Freenome developed and manufactured the test, which Abbott is exclusively commercialising for average-risk individuals aged 45 and above.
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This test expands the company’s existing diagnostic range, which also includes Cologuard Plus, to help screen individuals who might otherwise remain untested.
The American Cancer Society recommends blood-based options specifically for individuals who refuse or fail to complete preferred screening protocols, such as stool-based or direct visual examinations.
The PREEMPT CRC prospective validation trial assessed SimpleScreen CRC by analysing circulating cell-free deoxyribonucleic acid (cfDNA) in over 48,000 asymptomatic, average-risk individuals aged 45 to 85 years scheduled for a colonoscopy.
In a prespecified analysis adjusted to reflect the US Census, the blood test recorded an overall colorectal cancer sensitivity of 81.1%, with a 63.5% sensitivity for Stage I disease.
The trial also demonstrated a 13.7% sensitivity for advanced precancerous lesions and a 90.4% specificity for advanced colorectal neoplasia.
Abbott cancer diagnostics business senior vice-president Jake Orville said: “More screening options for colorectal cancer only matter if we help more people get screened. 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 prioritising 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 prioritise screening and prevention while providing another path to screening for people who might otherwise go unscreened.”
The test is covered under Medicare, with no out-of-pocket expenses for eligible Medicare Part B recipients, though Medicare Advantage beneficiaries may face out-of-pocket costs.
Abbott supports the test through a patient navigation programme that coordinates blood sampling at home via mobile phlebotomy or at participating laboratories, alongside insurance support, translation services, and screening reminders.
Patients with positive test results require a follow-up colonoscopy to complete screening.
Last month, the FDA approved Abbott’s TactiFlex Duo, a dual ablation catheter indicated for the treatment of atrial fibrillation.
