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Exact Sciences and Mayo Clinic study shows promise of new blood-based lung cancer test
Date:3/1/2017

MADISON, Wis., March 1, 2017 /PRNewswire/ -- A study from Exact Sciences Corp. (Nasdaq: EXAS) and Mayo Clinic released today by the American Association of Cancer Research (AACR) shows promise for the development of a blood-based lung cancer test. Researchers conducted a multi-round study of nearly 400 patients, which demonstrated high accuracy for detecting lung cancer at all stages.

"These results reveal an opportunity to detect lung cancer from a simple blood draw," said Kevin Conroy, chairman and CEO of Exact Sciences. "Our collaboration with Mayo Clinic is efficiently identifying biomarkers for additional cancer applications on the same technology platform as Cologuard."

AACR released an abstract of the study today, ahead of the presentation of the results on April 2, 2017, during the AACR 2017 annual meeting. The findings from the study of 398 patients (311 controls and 87 cancers) demonstrate that biomarkers in plasma achieved high accuracy for all types and stages of lung cancer. Using two independent regression modeling approaches, a panel of four novel methylated DNA markers demonstrated a sensitivity of 91-96 percent at a specificity of 90-94 percent.

"More studies are needed to corroborate accuracy, however, this plasma DNA test approach appears to be a promising new method and may serve as a rational follow-up to the common findings of lung nodules on CT scanning and may have application in screening for lung cancer," said David E. Midthun, M.D. a pulmonologist at Mayo Clinic.

Lung cancer is the leading cause of cancer mortality, resulting in 1.7 million deaths globally and more than 150,000 deaths in the United States every year.  Most symptoms present in the late stages of the disease, when the survival rate is only four percent. Early detection of lung cancer offers the opportunity to reduce mortality. Lung cancer screening is approved for smokers using chest CT scanning.  This approach has a sensitivity for lung cancer above 90 percent, but its specificity may fall below 75 percent (a false positive rate of more than 25 percent) because indeterminate lung nodules are so common. Evaluation of these false-positives leads to unnecessary, costly and potentially harmful procedures.

"A blood-based test may help guide next steps after a scan reveals an indeterminate nodule," Mr. Conroy said. "For example, a positive blood test might suggest the need for a biopsy or surgery. In contrast, a negative test might suggest a less aggressive approach. Such a test could offer the opportunity to significantly improve health outcomes and reduce the financial impact on the health care system."

The abstract is available here.

A poster presentation of the findings will take place Sunday, April 2, 2017, from 1 p.m. to 5 p.m. EDT at the Walter E. Washington Convention Center in Washington, D.C., Halls A-C, Poster Section 30. 

About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. For more information, please visit the company's website at www.exactsciences.com, follow Exact Sciences on Twitter @ExactSciences or find Exact Sciences on Facebook.

Safe Harbor Statement
This news release 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," "could," "seek," "intend," "plan," "estimate," "anticipate" or other comparable terms. All statements other than statements of historical facts included in this news release regarding our strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Examples of forward-looking statements include, among others, statements we make regarding expected future operating results, anticipated results of our sales and marketing 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. Our actual results and financial condition 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 our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: our ability to successfully and profitably market our products and services; the acceptance of our products and services by patients and healthcare providers; our ability to meet demand for our products and services; the willingness of health insurance companies and other payers to cover Cologuard and reimburse us for our performance of the Cologuard test; the amount and nature of competition from other cancer screening products and services; the effects of the adoption, modification or repeal of any healthcare reform law, rule, order, interpretation or policy; the effects of changes in healthcare pricing, coverage and reimbursement; recommendations, guidelines and quality metrics issued by various organizations such as the U.S. Preventive Services Task Force, the American Cancer Society, and the National Committee for Quality Assurance regarding cancer screening or our products and services; our ability to successfully develop new products and services; our success establishing and maintaining collaborative, licensing and supplier arrangements; our ability to maintain regulatory approvals and comply with applicable regulations; and the other 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 Report(s) 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.

Contact:
J.P. Fielder
Exact Sciences Corp.
jpfielder@exactsciences.com
608-210-5220

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