FDA Approves Exact Sciences' Cologuard Plus™ Test, Setting A New Benchmark in Non-Invasive Colorectal Cancer Screening

Original from: Exact Sciences

Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the U.S. Food and Drug Administration (FDA) approved the Cologuard Plus™ test, the company’s next generation multitarget stool DNA test. The Cologuard Plus test is now approved for adults ages 45 and older who are average risk for colorectal cancer (CRC).

FDA approval was based on findings from the pivotal BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening. Among the subset of nearly 19,000 average-risk participants, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no findings on colonoscopy.1* Results from BLUE-C also show the Cologuard Plus test significantly outperformed an independent fecal immunochemical test (FIT**) for overall CRC sensitivity, treatable-stage CRC (stages I-III) sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.

“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 at the Indiana University School of Medicine, research scientist at the Regenstrief Institute, and principal investigator for the BLUE-C study. “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.

“Cologuard Plus sets a new performance standard in non-invasive colorectal cancer screening for patients,” said Kevin Conroy, Chairman and CEO of Exact Sciences. “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.”

CRC is often considered the most preventable, yet least prevented form of cancer. It remains the second deadliest cancer in the United States. The Cologuard Plus test will build on the success of the Cologuard® test, which has been used more than 17 million times and helped meaningfully improve national CRC screening rates in the United States.5,6 Upon launch in 2025, the Cologuard Plus test will be supported by Exact Sciences’ commercial organization and industry-leading ExactNexus™ technology platform, making ordering and resulting seamless for more than 350 health systems. The innovative, non-invasive test is anticipated to be covered by Medicare, included in the U.S. Preventive Services Taskforce (USPSTF) guidelines, and included within quality measures.

Source: FDA Approves Exact Sciences' Cologuard Plus™ Test, Setting A New Benchmark in Non-Invasive Colorectal Cancer Screening