Cologuard Plus Receives FDA Approval For Non-Invasive Colorectal Cancer Screening

Today, the FDA approved the Cologuard Plus test, a multitarget stool DNA test that can screen adults ages 45 and older who are at average risk for colorectal cancer, according to a news release from Exact Sciences.¹

Colorectal cancer is common, but often goes undiagnosed. | Image credit: © Dr_Microbe | stock.adobe.com

Approval was based on positive results from the BLUE-C trial (NCT04144738), which found that the test showed 93.9% sensitivity for colorectal cancer and 43.4% sensitivity for advanced precancerous lesions. There was 90.6% specificity for advanced neoplasia.^2,3

In the label population, which was around 19,000 individuals at average risk of colorectal cancer, Cologuard Plus demonstrated 95% overall cancer sensitivity, in addition to 43% sensitivity for advanced precancerous lesions at 94% specificity.¹

Importantly, those results also indicate that Cologuard Plus demonstrated significant superiority over an independent fecal immunochemical test (FIT) for overall colorectal cancer sensitivity, treatable-stage colorectal cancer sensitivity, and advanced precancerous lesion sensitivity.²

Thomas F Imperiale, MD, principal investigator for the BLUE-C study, spoke to the need to find advanced precancers to improve outcomes in patients with colorectal cancer.¹

“The high colorectal cancer sensitivity and specificity of the Cologuard Plus test gives me confidence in the test’s ability to do just that while simultaneously maintaining a low risk of false positives,” he said in the news release. “This makes the Cologuard Plus test a strong option for first-line screening of average risk patients.”¹

New, less invasive colorectal cancer screening options are increasingly hitting the market as data show their effectiveness. Earlier this year, the FDA approved a novel blood test from Guardant Health which can screen for colorectal cancer in adults ages 45 and older at average disease risk.⁴

Despite being a highly treatable form of cancer, colorectal cancer is the second most common cause of cancer deaths between men and women. Oftentimes, the disease is diagnosed in its later stages because its symptoms are obscure and can be confused for being due to any number of casual factors.⁴

Access to screening represents a major hurdle to increasing colorectal cancer detection in men and women. The features of the Cologuard Plus could make the screening process more efficient and less time-consuming. The test features novel biomarkers and improved laboratory processes, while incorporating enhanced sample stability components. These will allow patients more time to return their sample to a lab and increase the rate of valid results, according to the news release.¹

“Cologuard Plus sets a new performance standard in non-invasive colorectal cancer screening for patients,” Kevin Conroy, chairman and CEO of Exact Sciences, stated in the news release. “This breakthrough comes at a critical time, when 60 million Americans are not up to date with screening.”¹

The test is expected to launch with corresponding Medicare coverage and guidelines surrounding its use in 2025.¹

REFERENCES

1. Exact Sciences. FDA approves Exact Sciences’ Cologuard Plus test, setting a new benchmark in non-invasive colorectal cancer screening. News Release. Released October 4, 2024. Accessed October 4, 2024. https://www.exactsciences.com/newsroom/press-releases/fda-approves-exact-sciences-cologuard-plus-test

2. Imperiale TF, Porter K, Zella J, et al. Next-generation multitarget stool DNA test for colorectal cancer screening. N Engl J Med. 2024;390(11):984-993. doi:10.1056/NEJMoa2310336

3. ClinicalTrials.gov. Clinical validation of an optimized multi-target stool DNA (Mt-sDNA 2.0) test, for colorectal cancer screening “BLUE-C.” National Library of Medicine. Last Updated September 1, 2023. Accessed October 4, 2024. https://clinicaltrials.gov/study/NCT04144738

4. Gerlach A. FDA approves novel blood test as a primary screening option for colorectal cancer. Pharmacy Times. Published July 29, 2024. Accessed October 4, 2024. https://www.pharmacytimes.com/view/fda-approves-novel-blood-test-as-a-primary-screening-option-for-colorectal-cancer