ACS guideline reaffirms Abbott leadership in noninvasive colorectal cancer screening

ACS guideline reaffirms Abbott leadership in noninvasive colorectal cancer screening

• Cologuard^® and Cologuard Plus^® reaffirmed as preferred options for noninvasive colorectal cancer (CRC) screening in updated American Cancer Society guideline
• Abbott to offer only CRC screening portfolio aligned to new ACS recommendations combining preferred stool-based plus additional blood-based options
• Recent publications support Cologuard-first strategy, demonstrating better outcomes for patients, providers, health systems, and payers

ABBOTT PARK, Ill., May 27, 2026 /PRNewswire/ -- Abbott (NYSE: ABT) today announced that the American Cancer Society (ACS) has released updated colorectal cancer (CRC) screening guidelines that reaffirm Cologuard^® and Cologuard Plus^® as preferred noninvasive screening options for adults age 45 and older who are at average risk for CRC. Both tests are used at a three-year interval.

Cologuard and Cologuard Plus are preferred, U.S. Preventive Services Task Force-recommended noninvasive screening tests designed to detect CRC early – when it is most treatable – and identify precancerous lesions that can be removed during follow-up colonoscopy.¹ Cologuard Plus detects 95% of colorectal cancers at 94% specificity age-weighted to the U.S. screening population, which is expected to minimize unnecessary follow-up colonoscopies and maximize confidence in results.^2* Both tests are backed by Abbott's well-established patient navigation support and commercial infrastructure to ensure scale, reliability, and seamless patient and provider experiences. Further, both tests are included in colorectal cancer screening quality measures, such as HEDIS and Stars, which support payer and provider quality incentives.

"Colorectal cancer is highly treatable when caught early – survivable in about 90% of cases – and is even preventable when pre-cancers are found and removed. But still, up to 60 million eligible Americans remain unscreened," said Dr. Xavier Llor, professor of medicine and director, GI and Pancreatic Cancer Prevention Program, Yale School of Medicine.^{† "}Screening tools like Cologuard and Cologuard Plus allow us to offer additional well-performing options to cater to the needs of different patients, increasing the chances at positively impacting incidence and mortality rates from this devastating disease in the United States."

Abbott Uniquely Positioned to Expand Screening in Line with ACS Guideline
With the proven performance and broad adoption of Cologuard and Cologuard Plus, alongside Abbott's agreement to commercialize a blood-based test from Freenome, pending FDA approval, Abbott is uniquely positioned across the spectrum of noninvasive CRC screening. Upon approval, Abbott will launch the blood-based test with a seamless ordering experience designed to expand participation among individuals who decline other screening methods. Cologuard tests will continue to serve as preferred first-line screening options to help drive optimal outcomes. Both tests will leverage Abbott's Nexus platform, which helps providers identify patients who are not up to date on CRC screening and improve adherence over time.

Proven CRC Screening Impact of Cologuard Enters New Era with Cologuard Plus
Cologuard tests have transformed colorectal cancer screening, driving an estimated 77% of the nationwide increase in CRC screening participation from 2018 to 2021.³ First included in the ACS Colorectal Cancer Screening Guideline in 2014, the tests have been used more than 23 million times.⁴ Supported by a robust patient navigation program, Cologuard tests have demonstrated strong real-world adherence to initial screening,⁵ category-leading follow-up colonoscopy rates when needed,⁶ and high patient satisfaction,⁴ supporting repeat screening at the guideline-recommended three-year interval.

This impact is further reinforced by peer-reviewed modeling studies. One recently published analysis found that a Cologuard-first screening approach could nearly double CRC detection, prevent more cancers through the detection and removal of precancerous lesions, and reduce CRC-related costs while allowing colonoscopy capacity to focus on follow-up and therapeutic procedures.⁷ A separate modeling study suggests that Cologuard Plus, when used at guideline-recommended intervals, could detect more cancers and precancerous lesions, reduce mortality, and deliver substantially more life-years gained over 10 years than a single screening colonoscopy.⁸ These outcomes were driven by strong test performance and high adherence to both initial screening and follow-up colonoscopy.

"The updated ACS guideline reinforces the importance of screening approaches that combine strong clinical performance with the ability to reach more patients," said Paul Limburg, M.D., chief medical officer, screening, Abbott's cancer diagnostics business. "With Cologuard and Cologuard Plus established as preferred first-line screening options, Abbott is well-positioned across both stool- and blood-based approaches to help close persistent screening gaps and improve outcomes in colorectal cancer."

ACS is a leading cancer advocacy organization that develops evidence-based guidelines to inform clinicians, policymakers and the public, helping shape cancer prevention, screening, and early detection practices.

About the Cologuard and Cologuard Plus tests
Developed in collaboration with Mayo Clinic, the Cologuard and Cologuard Plus tests are first-line, noninvasive colorectal cancer (CRC) screening options for adults aged 45 or older who are at average risk for the disease. The Cologuard test revolutionized CRC screening by detecting specific DNA markers and blood in stool associated with cancer and precancer, allowing patients to complete the collection kit at home without special preparation or time off, and return the kit to the lab for results. It is also the only noninvasive molecular CRC screening test recommended by USPSTF (2021), and both Cologuard and Cologuard Plus are included in HEDIS^® quality measures and the ACS guidelines (2026).

Building on this success, the FDA-approved Cologuard Plus test features novel biomarkers, improved laboratory processes, and enhanced sample stability. Through high performance, the Cologuard Plus test is designed to reduce the likelihood of false positives, helping to minimize unnecessary follow-up colonoscopies. Further, Cologuard Plus is the only noninvasive test FDA-approved for both cancer and precancer detection. Both tests demonstrate Abbott's commitment to improving CRC screening access and outcomes.

Cologuard and Cologuard Plus rely exclusively on molecular data from the patient sample – not subjective patient-reported risk factors – reducing variability, improving accuracy, and enabling faster results.

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries. Connect with us at abbott.com and on LinkedIn, Facebook, Instagram, X and YouTube.

^* 94% specificity when age-weighted to the U.S. screening population. Cologuard Plus specificity: 91% overall specificity, including all participants who did not have advanced neoplasia.
^† Dr. Xavier Llor previously served as a principal investigator on a study with Exact Sciences, which is now Abbott. He was not compensated for media work.

1. Davidson KW, Barry MJ, Mangione CM, et al. Screening for colorectal cancer - US Preventive Services Task Force recommendation statement. JAMA. 2021;325(19):1965-1977.
2. Cologuard Plus™ Clinician Brochure. Madison, WI: Exact Sciences Corporation.
3. Ebner DW, Finney Rutten LJ, Miller-Wilson LA, et al. Trends in colorectal cancer screening from the National Health Interview Survey: Analysis of the impact of different modalities on overall screening rates. Cancer Prev Res (Phila). 2024; 17(6):275-280.
4. Data on file. Exact Sciences Corporation; Madison, WI. Cologuard Tests Completed. [CL-000581]. 2026.
5. Le QA, Greene M, Gohill S, et al. Adherence to multi-target stool DNA testing for colorectal cancer screening in the United States. Int J Colorectal Dis. 2025;40:16.
6. Greene M, Stieber B, LeMaster JW, et al. Closing the loop in colorectal cancer screening: real-world adherence to follow-up colonoscopy after positive mt-sDNA vs FIT/FOBT, stratified by payer type. Curr Med Res Opin. 2025;41(9):1629-1639.
7. Fendrick AM, Kurlander JE, Vahdat V, Estes C, Gohil S, Limburg PJ, Lieberman DA. Optimizing colonoscopy capacity to maximize colorectal cancer outcomes. Gastro Hep Adv. 2026. doi: 10.1016/j.gastha.2026.100930.
8. Dore M, Ebner DW, Vahdat V, Estes C, Ozbay AB, Foster V, Limburg PJ. Model-based evaluation of colorectal cancer screening effectiveness: three rounds of multitarget stool DNA testing versus one colonoscopy. J Med Econ. 2026;29(1):986-993. doi:10.1080/13696998.2026.2645491

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SOURCE Abbott