US-based molecular diagnostics company Exact Sciences has received the US Food and Drug Administration (FDA) approval for its Cologuard Plus test for colorectal cancer (CRC) screening.
Cologuard Plus is a multitarget stool DNA test, developed in collaboration with Mayo Clinic, and approved for use with adults ages 45 and above, who are at average risk for CRC.
Exact Sciences said its Cologuard Plus test features novel biomarkers, improved laboratory processes, and enhanced sample stability components.
The next-generation cancer screening test builds on the company’s existing Cologuard test, which helped improve CRC screening rates in the US.
Exact Sciences intends to start commercialising the Cologuard Plus test in 2025.
Its commercial organisation, dubbed ExactNexus technology platform, will support the launch, simplifying the ordering and results for more than 350 health systems.
Exact Sciences chairman and CEO Kevin Conroy said: “Cologuard Plus sets a new performance standard in non-invasive colorectal cancer screening for patients.
“Cologuard Plus detects cancers and precancerous polyps with even greater sensitivity than Cologuard while reducing false positives by more than 30%.
“This breakthrough comes at a critical time when 60 million Americans are not up to date with screening.”
The FDA approval is based on results from the BLUE-C study, a large-scale head-to-head study of the Cologuard Plus test in more than 20,000 adults, aged 40 years and above.
In the study, Cologuard Plus showed a 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no findings on colonoscopy.
According to the study results, the Cologuard Plus test significantly outperformed an independent faecal immunochemical test (FIT).
The test showed superior overall CRC sensitivity, treatable-stage CRC (stages 1-3) sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity compared to FIT.
Furthermore, the non-invasive test is expected to be covered by Medicare and included in the US Preventive Services Taskforce (USPSTF) guidelines, said the molecular diagnostics firm.
BLUE-C study principal investigator Thomas Imperiale said: “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.
“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.”
