AdvaMed (Advanced Medical Technology Association) gave Cologuard high marks as a case study showcasing the value of diagnostic tests in the U.S. healthcare system in a report they published last month.                                                                     

AdvaMed is a medical device trade association that supports efforts to advance medical technologies. The medical diagnostics division of AdvaMed, chose to feature Cologuard as an example of new and valuable diagnostic technologies. Their assessment is communicated in the publication, Application of the Comprehensive Assessment of the Value of Diagnostic Technologies Framework to Exact Sciences Cologuard Multi-target sDNA Test.

The impetus for AdvaMed’s evaluation of Cologuard was its decision to address the “growing need to demonstrate how diagnostic tests fit into the emerging value-based paradigm for providers, payers, and patients.” To this end they developed a framework to communicate the value of diagnostic technology as our healthcare system undergoes a shift from fee-for-service to a value based model.

Their approach uses four categories, or “value drivers,” to describe each new technology, all determined to be highly relevant to its many different and potential stakeholders. The drivers include: clinical impact, non-clinical patient impact, care delivery revenue and cost impact, and public/population impact. At Exact Sciences, we enthusiastically support such a framework that considers all stakeholders in the healthcare delivery system and highlights the value for patients.

The results of AdvaMed’s case study of Cologuard are summarized in this statement taken directly from the report:

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Exact Sciences’ Cologuard multi-target sDNA test demonstrates value across all of the drivers and serves as an example of the appropriate application of the AdvaMed value assessment approach in establishing value for a range of stakeholders.

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More specifically, the assessment found that in terms of clinical impact, Cologuard may lead to an earlier cancer diagnosis, which in turn leads to earlier interventions and better outcomes for patients. The technology’s non-clinical impact value is demonstrated by patients who experience greater satisfaction with a screening test that is non-invasive and carries a very low risk of complications. As for cost impact value, the report concludes that Cologuard is poised to generate both short and long-term healthcare cost savings, and the final value driver – public impact value – achieves its goal because Cologuard provides an opportunity to expand the pool of screened patients.

Exact Sciences designed the Cologuard colorectal cancer screening system to address an immense unmet clinical and public health need and prioritized focus on four key features:

• A home-based test with high performance for colorectal cancer and pre-cancerous lesion detection
• Patient preference for privacy and no need for preparation or time away from work
• A nationwide, 24/7 patient navigation and compliance program along with a provider support service
• A non-invasive test with a very low risk of harm to patients and populations

With only 62 percent of screening eligible individuals in the U.S. up to date with colorectal cancer screening, Cologuard offers the best non-invasive screening option. And, for patients 50 years old and older, Cologuard should be positioned as the best non-invasive choice for colorectal cancer screening.