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Investor & Analyst Day Q&A: Your Questions Answered

Disclaimer: The information and data presented below was prepared for investors and potential investors. It includes forward-looking information on investigational products in development that are not available for sale in the United States. These include early-stage development products for which the performance characteristics have not yet been established.

In the weeks leading up to Exact Sciences' inaugural Investor & Analyst Day, we asked those of you who would not be attending to send us questions to be answered by our management team. 

Many of your questions were answered during the presentations, but we've highlighted a few questions from the Q&A session and from the web, complete with answers, below.

Q: What’s surprised you the most about the Cologuard launch?

A: Seeing how badly both physicians and patients want to order this test. Data shows one of our reps in the Southeast reached 99% of her targeted physicians, and over 65% of them have ordered Cologuard. In total, we’ve had over 80,000 tests ordered. That’s really good data for a brand new launch.

Q: Why don’t we see larger percentage of Cologuard patients who have done FIT or FOBT in the past?

A: This is due in part to the fact that 80% of our patients are Medicare, which skews the data. 

Additionally, people who are currently undergoing colonoscopy frequently do not want to continue screening this way, so they try it once and then never do it again. Those people are switching to Cologuard. We’re also getting people that have never been screened before.

In the long-term term sense, people want to get Cologuard - not just FIT or FOBT patients. And we think, from the long-term trend, this is extremely exciting.


Q: Can we have an update on the post-approval study for Cologuard?

A: The post-approval study is required by FDA following FDA approval, and that study is underway. Enrollment is expected to be completed in one year; we’re working hard to make that happen.

Q: When can we expect to see data around pancreatic cancer screening and other pipeline products?

A: The early data around pancreatic juice is pretty remarkable: over 90% sensitivity, over 90% specificity, an optimized assay, best fit assay, more work needs to be done there. We will shoot for similar targets with both esophageal and lung cancer. We will have a timeline for when you can expect to see that data soon.


Q: Do you have any plans to develop a stomach cancer screening test?

A: Stomach cancer is a test that we believe could be detected using methylation markers and stool collection in the Cologuard collection kit.

The challenge is that stomach cancer incidence rates are very low in the US, which is our primary market, and Europe. They’re very high in Korea and parts of China, but at this point we made a decision not to invest in that program because of the limited market opportunity.

Q: How is the leadership team balancing devoting resources to the launch of Cologuard vs. the product pipeline and other new developments?

A: That's an important question. We are committing significant resources to sales and marketing and the energy and focus of the team is largely on advancing Cologuard.

We know we need that to make Cologuard a success if we want to make these other things a reality, and that's what our leadership team is focused on.

Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit www.CologuardTest.com. Rx Only.

Topics: Exact Sciences News

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