Screening

main office: Madison, wi

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general manager:
Meet mark stenhouse

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Product: Cologuard

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Cologuard Market

Cologuard is the first and only FDA approved, non-invasive, multi-target, stool-based colorectal cancer screening test. There are 106 million Americans at average risk for colorectal cancer who should be screened regularly. Today, an estimated 46 million of them are not up to date with screening recommendations. Cologuard has helped screen more than 4 million people since it was made available and has captured about 5 percent of the addressable market. Our long-term goal is to help meaningfully impact colon cancer screening rates, eradicate this terrible disease, and capture at least 40% of the market with Cologuard, which equates to about $7 billion in annual revenue.

Source: Exact Sciences estimates, assuming 106 million average-risk, asymptomatic people ages 45-85, revenue per test of $500-$525, and 3-year interval for Cologuard; market share = ($219M 1Q20 Cologuard revenue x 4 to annualize / $18B TAM)

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Sales and marketing Strength

The commercial organization supporting our Screening business is unmatched in screening and diagnostics. We have about 500 primary care, 60 gastroenterology, and 35 health system field sales representatives. We also have strong marketing, insurance coverage, and medical teams supporting our representatives, as well as an effective, nationwide, direct-to-consumer marketing campaign. Our experienced customer care specialists are available 24 hours a day, 7 days a week to support patients and answer any questions they have about completing Cologuard.

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Growth opportunities

In the near-term, we expect our sales force and marketing initiatives to continue to support Cologuard growth. We also see several mid- and long-term growth drivers that can help achieve our 40% market share goal. In the mid-term, the expansion of Cologuard’s label to include the 19 million average risk Americans ages 45-49 is an important opportunity to screen people earlier and to impact the rising incidence of colorectal cancer in younger adults. For the long-term, we're working to develop an enhanced version of Cologuard to further differentiate it as a front-line screening test.

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Earlier detection means earlier treatment. People shouldn’t fear it.”

Patient Story

No matter how busy Susan was volunteering in her Ohio community, she always made sure to stay up to date with colorectal cancer screening.

When it was time to screen again in 2019, Susan asked her healthcare provider about her screening options, including Cologuard. Her healthcare provider prescribed Cologuard, and Susan completed the test at her home. After receiving a positive result, Susan quickly followed up with a diagnostic colonoscopy, which revealed a large precancerous polyp.

“I think about what would have happened if I had waited,” Susan says. “Why put screening off?”

Susan underwent surgery to remove part of her colon and did not require any additional treatment. As a lifelong health advocate and volunteer, she feels compelled to share her story with others.

Forward-Looking Statements

This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the"safe harbor" created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as "believe," "expect,""may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate" or other comparable terms. All statements other than statements of historical facts included in this report regarding our strategies, prospects, expectations, goals, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected growth opportunities and market share, future operating results, anticipated results of our sales, marketing and patient adherence efforts, expectations concerning payer reimbursement, and the anticipated results of our product development efforts. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Actual results, conditions and events may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results, conditions and events to differ materially from those indicated in the forward-looking statements include, among others, the risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and our subsequently filed Quarterly Reports on Form 10-Q. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.