FDA Approves Exact Sciences' Cologuard Plus Non-Invasive Colorectal Cancer Screening Test

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The FDA has approved Exact Sciences' Cologuard Plus, a non-invasive colorectal cancer (CRC) screening test, for adults aged 45 years and older with an average risk for CRC. According to the company, the regulatory action was based on results from the pivotal BLUE-C study, which demonstrated sufficient sensitivity in detecting colorectal cancer and advanced precancerous lesions.¹

“To meaningfully improve outcomes in colorectal cancer, we must catch cancer early—when it is most treatable—and find advanced precancers, which can prevent cases of this cancer,” said Thomas F. Imperiale, MD, professor of medicine, Indiana University School of Medicine, research scientist, Regenstrief Institute, principal investigator, BLUE-C study, in a press release. “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. This makes the Cologuard Plus test a strong option for first-line screening of average risk patients.”

The multi-center, prospective BLUE-C study included over 20,000 adults over 40 years of age to evaluate the performance of the Cologuard Plus test and the company’s blood-based colorectal cancer screening test. Forty percent of study participants identified as Hispanic or Latino, Black, Asian, American Indian or Alaska Native, or Pacific Islander. The study directly compared the Cologuard Plus test with an independent fecal immunochemical test.

Results found that Cologuard Plus demonstrated 95% sensitivity for detecting colorectal cancer and 43% sensitivity for advanced precancerous lesions, with a 94% specificity. Further, the test also outperformed the fecal immunochemical test in detecting treatable-stage CRC and advanced lesions.¹

According to the American Cancer Society, there will be approximately 106,590 new cases of colon cancer and 46,220 new cases of rectal cancer by the end of this year in the United States. Between 2011 and 2019, rates dropped 1% each year, mainly due to the high number of people undergoing screening. However, these statistics only account for older populations, as people younger than 55 years of age have experienced an increase of 1% to 2% a year since the mid-1990s.

Over an individual lifetime, the chances of getting colorectal cancer are one in 23 for men and one in 25 for women. Currently, it is the third leading cause of cancer-related deaths in men and the fourth leading cause in women, but it’s the second most common cause of cancer deaths when numbers for men and women are combined.²

“Cologuard Plus sets a new performance standard in non-invasive colorectal cancer screening for patients,” said Kevin Conroy, chairman, CEO, Exact Sciences, in a press release. “Cologuard Plus detects cancers and precancerous polyps with even greater sensitivity than Cologuard while reducing false positives by more than 30 percent. This breakthrough comes at a critical time, when 60 million Americans are not up to date with screening.”

Set to launch in 2025, the Cologuard Plus test is expected to be covered by Medicare and included in national preventive guidelines. Exact Sciences will leverage its ExactNexus platform for integration across over 350 health systems. Developed in collaboration with the Mayo Clinic, Exact Sciences stated that the test incorporates enhanced sample stability components to provide patients more time to return their sample to a lab and increase the valid result rate. The company is currently preparing for commercialization of the test.¹

References

1. FDA Approves Exact Sciences’ Cologuard Plus Test, Setting a New Benchmark in Non-Invasive Colorectal Cancer Screening. BusinessWire. October 4, 2024. Accessed October 4, 2024. https://www.businesswire.com/news/home/20241004761985/en

2. Key Statistics for Colorectal Cancer. American Cancer Society. Accessed October 4, 2024. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html