FDA Pivotal Clinical Trial

The main result that will be measured is a
comparison of Cologuard™ to colonoscopy.

My name is Nada Mlinarevich. I work on Exact's clinical trial team. My job is to ensure a successful trial through the work of both our internal and external teams. The task of planning, running and completing a clinical trail is difficult and highly complex. But our team thrives on that difficulty and complexity. I'm excited to be involved because I know that successfully finishing the trial brings Cologuard one step closer to the market. All of us on the team work closely with Jameille, whose father battled colon cancer. We know that early detection can change the story of colon cancer in so many families. That's what we're working for.

During 2010, Exact made great progress putting the many complex pieces of the clinical trial in place and those great efforts have continued in 2011. It's not surprising, though, given the strength and experience of the clinical research organization we've engaged and the outstanding team we've put together both inside the company and out. We've assembled the same team that successfully completed the clinical trial and secured FDA approval of the Cervista HPV test.

Together, our team has done the work that enables us to begin enrolling patients in the third quarter of 2011. We've qualified more than 40 sites across the country to ensure that we meet our enrollment goals on time and that our patient population is diverse. We're continuing to qualify additional sites. Once the trial closes, it will take roughly three months to compile and submit our application to the FDA for approval of Cologuard.

We'll be enrolling patients with average risk for colorectal cancer. These patients fall between the ages of 50 and 84, and have none of a list of well-defined and well-known risk factors for the disease. We expect to enroll between 10,000 and 12,000 patients. We also expect that 50 to 60 of these patients will have colon cancer and up to 500 will have a pre-cancerous polyp. These patient enrollment goals ensure that the clinical trial is statistically acceptable, an important component of our submission to the FDA following the trial.

Every patient will undergo three tests: our Cologuard test, which includes a FIT test that can detect blood in the stool; a separate, commercially available FIT test; and a colonoscopy. The primary endpoint of the trial, or the main result that will be measured at the end of the trial, is a comparison of the performance of Cologuard in the trial to colonoscopy's performance. The secondary endpoint is a comparison of Cologuard to FIT.

We are very pleased that Medicare, which covers approximately 50 percent of those 50 and older, will do a parallel review with the FDA of Cologuard for a national coverage decision about the product. A parallel review is not common and gives Exact the potential to have both FDA approval and a Medicare national coverage decision on an accelerated timeline.

Everyone on Exact's clinical trial team is proud of the work we've done to prepare for the company's biggest investment to date. But we know there's still a lot at stake—for the company and for colon cancer patients and their families. We won't forget either as we continue our work to deliver a successful clinical trial.