Driving Meaningful Scientific Innovation in the Prevention and Detection of Colorectal Cancer

When novel healthcare discoveries are identified, the hope is that they will immediately impart positive practice change, but that perception is typically far from reality. Widespread clinical adoption of scientific advances often takes many years to achieve, in part due to the time needed for generating a robust, high-quality evidence base that cannot be accelerated by taking shortcuts.

A Mission-Driven Journey

At Exact Sciences, our scientific research always starts with two questions: what is the unmet clinical need, and as a molecular diagnostics company, how can we apply the power of molecular science to address it?

It’s this approach that led us to the next-generation Cologuard® test. More than a decade ago – even before the current Cologuard test was finalized and FDA approved – we were already planning for how the next version could provide additional benefits. For us, improving specificity represented an important opportunity. The key question was: can our continued discovery efforts to identify new molecular markers actually deliver a non-invasive screening test that has even greater specificity, without compromising sensitivity (i.e., the ability to accurately detect the presence of cancer)?

This objective was important to us because increasing the specificity of screening tests translates to fewer patients needing to undergo unnecessary follow-up colonoscopies due to false positive test results, thereby improving the patient experience and reducing associated healthcare costs.

A Rigorous Scientific Approach

Addressing the unmet clinical need requires rigorous scientific research, thoughtful data interpretation, clear and effective communication, and widespread clinical application to meaningfully alter the status quo.

For the next-generation Cologuard test, we collaborated with researchers from Mayo Clinic and undertook a comprehensive discovery and selection process to identify new molecular markers for the updated assay panel, leveraging more than a decade of colorectal cancer detection and prevention experience gained from the initial and growing adoption of Cologuard.

Next, we defined and validated the performance algorithm for the next-generation Cologuard test by leveraging unique resources such as archived, prospectively collected samples from the original DeeP-C clinical validation study that paved the way for the introduction of Cologuard.

And most recently, we completed the BLUE-C clinical trial, a large 20,000-person multi-center study of next-generation Cologuard, with a study population reflective of the overall U.S. population in terms of race and ethnicity, providing support that the performance data for this new colorectal cancer screening test are relevant to all eligible patients.

Our Never-Ending Mission

Despite progress to date, our commitment to innovation must remain steadfast, especially while an estimated 60 million eligible Americans are not up to date with current colorectal cancer screening recommendations.

With an eye toward the future, we are retaining blood samples from BLUE-C for future investigation of a blood-based colorectal cancer screening test that we currently have under development. We’re also investing in research to define the appropriate clinical application for blood-based screening options—with the biological limitations of detecting indicators of both cancers and precancers in blood, this approach would best be considered only after other currently recommended screening strategies are declined.   
From here, it’s exciting to envision where innovation will continue to further shape the field of cancer detection and prevention, especially in the age of further exciting advances as represented, for example, by the application of artificial intelligence to unsolved public health challenges.

Our goal is to eradicate cancer and the suffering it causes, but we know that eradicating colorectal cancer is bigger than one test. It’s bigger than one company. The collective whole – the medical community, the industry, research and development, the patient and advocacy communities, and the general population – will need to work together to change the trajectory of this all-too-common condition.

Disclaimer: The next-generation Cologuard test is under development and the features above describe current development goals. It has not been cleared or approved by the US Food and Drug Administration (FDA) or any other national regulatory authority.

References

American Cancer Society. Colorectal Cancer Facts & Figures 2023-2025. Atlanta: American Cancer Society; 2023.