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Cologuard™ Product Development

We made important enhancements
to our product that will benefit
physicians, labs and patients.

My name is Mike Domanico. I lead the team that was responsible for many of the enhancements we made to our product during 2010. When you work in diagnostics like I do, you develop an appreciation of your work's positive effect on people. When we met with Carol Chase Bjerke, a local author, artist and colon cancer survivor, we began to understand that impact more completely. The work we've done to optimize Cologuard can touch the lives of millions like Carol.

We evaluated many colorectal cancer markers to determine the best combination for the detection of pre-cancer and cancer. Cologuard is a combination of well-characterized DNA methylation and mutation markers and a fecal blood test called FIT, a combination shown to be very effective by our feasibility studies. These markers belong to different categories, each representing a unique opportunity to detect colon cancer and pre-cancers.

Our multi-marker approach covers more of the diagnostic landscape for colon cancer than other methods and we believe it will lead to a new colon cancer screening paradigm. Patients with a positive result from our test—in the pre-cancerous or early stages, we hope—will be referred to colonoscopy for removal of the polyp or tumor.

The benefits of our approach, in addition to detecting both pre-cancers and cancer, are that it's non-invasive, requires no bowel preparation and enables easy access to screening through a kit that patients use and mail back to the lab.

During 2010, we made important enhancements to our product. Together, they will benefit physicians, labs and, most important, patients through increased performance and ease of use.

We made dramatic improvements to Cologuard's DNA extraction technology, which increased its analytical performance. This technology now yields 200 percent more DNA than before. This is particularly important for pre-cancer detection, when you're looking for a sometimes rare copy of DNA from a small lesion. We've reduced extraction time from 48 hours to three, making it easier to automate and integrate into a lab's workflow.

Additional DNA methylation markers became part of the test panel during 2010. When DNA becomes methylated, that gene's activity can be switched off. Abnormal methylation is strongly associated with colon cancer development. DNA methylation detection strengthens our unique approach to colorectal cancer screening by providing a different detection pathway.

We recently began an exciting lab instrument automation program that will make Cologuard easier to use, more reproducible and more repeatable. Our automation team is focused on delivering the easiest to use, most efficient automation solution to lab customers.

2010 was a productive year for our team and we're off to a great start in 2011. We're dedicated to delivering the very best product to market. All of us are committed to ensuring that there are more survivors, like Carol, through the early detection and prevention of colon cancer.