Exact Sciences and MD Anderson Cancer Center Announce Partnership to Develop Screening and Diagnostic Tests for Lung Cancer

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Molecular Diagnostics Leader and Preeminent Cancer Research Institution Launch Program to Identify Lung Cancer in Early Stages

MADISON, Wis., & HOUSTON, Texas—(BUSINESS WIRE)—Exact Sciences Corp. (NASDAQ: EXAS) and The University of Texas MD Anderson Cancer Center today announced an agreement to jointly develop and commercialize blood-based screening and diagnostics tests for the early detection of lung cancer.

This unique collaboration seeks to build upon MD Anderson’s extensive research into predictive biomarkers for lung cancer and Exact Sciences’ successful development and commercialization of Cologuard®, the only FDA-approved, non-invasive colon cancer screening test. The two groups plan to develop a groundbreaking new blood test that targets biomarkers associated with lung cancer.  

The collaboration specifically aims at developing a blood-based lung cancer screening test to determine the need for low-dose computed tomography (LDCT). This test would offer the opportunity to screen nearly 11 million Americans considered high risk smokers and former smokers. The partnership is also aimed at developing a diagnostic test to determine the malignant status of nodules found through LDCT screening. This test would be valuable to nearly 4 million Americans diagnosed with lung nodules each year. 

“Our common vision is to help win the war on cancer through early detection.  Taking on lung cancer offers an opportunity to build on the success of Cologuard,” said Exact Sciences’ Chairman and CEO Kevin Conroy. “A simple blood test to complement a LDCT scan could significantly improve early-stage lung cancer detection. Our experience working with regulators and insurers coupled with MD Anderson’s world-class research and development capabilities are an ideal match to make a meaningful difference in the war on cancer.”

The American Cancer Society estimates that lung cancer will be diagnosed in 221,200 Americans and cause 158,040 deaths in the United States this year. Currently, more than half of lung cancer cases are diagnosed at an advanced stage, after symptoms appear, when the five-year survival rate is in the low single digits. If detected at an early stage, lung cancer’s five-year survival rate can be as high as 80 percent. 

“Lung cancer is, and will continue to be, America’s leading cancer killer unless we identify new approaches to diagnose it early, at its most treatable stages,” said Sam Hanash, M.D., Ph.D., director of MD Anderson’s Red and Charline McCombs Institute for the Early Detection and Treatment of Cancer.  “Our collaboration with Exact Sciences provides a great opportunity to create tests that could shift the lung cancer detection paradigm for the benefit of patients.”

Hanash’s research spans a variety of biomarker types – including DNA, proteins, metabolites, autoantibodies. “Our goal is to choose the best-performing biomarkers for our panel across multiple technologies,” Hanash said, as opposed to the more common practice of relying on a single type of biomarker.

The initiative is part of MD Anderson's Moon Shots Program, a goal-oriented, multidisciplinary effort harnessing available knowledge and new disruptive technologies to dramatically reduce cancer mortality through prevention, early detection and curative treatments. The program's innovative approach focuses initially on eight cancers: lung, breast, ovarian, prostate, melanoma, chronic lymphocytic leukemia, myelodysplastic syndromes and acute myeloid leukemia.  Early detection was chosen as a flagship project of the Lung Cancer Moon Shot, funded initially by the Lyda Hill Foundation.

Currently LDCT scanning is reimbursed by Medicare for high-risk smokers and received a Grade B rating from the U.S. Preventive Services Task Force, leading clinicians nationwide to increase screening programs in recent years. The clinical challenge is that while LDCT is about 94 percent sensitive, it has a 73 percent specificity for the initial screen. As a consequence of the lower specificity of CT, 96 percent of all nodules discovered via LDCT scans are benign, leading to unnecessary and often harmful invasive procedures, radiation exposure and high costs.   More information about improving lung cancer detection with a new cost-effective blood-based test is available in this report from Exact Sciences and MD Anderson. 

About MD Anderson Cancer Center        

The University of Texas MD Anderson Cancer Center in Houston ranks as one of the world's most respected centers focused on cancer patient care, research, education and prevention. It is one of only 41 comprehensive cancer centers designated by the National Cancer Institute (NCI). For the past 25 years, MD Anderson has ranked as one of the nation's top two cancer centers in U.S. News & World Report's annual "Best Hospitals" survey. It receives a cancer center support grant from the NCI of the National Institutes of Health (P30 CA016672). 

About Exact Sciences Corp.

Exact Sciences Corp. (NASDAQ: EXAS) 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 noninvasive, molecular screening technology for the detection of colorectal cancer. Cologuard is included in the colorectal cancer screening guidelines of the American Cancer Society and stool DNA is included in the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please follow us on Twitter @ExactSciences or find us on Facebook.

Certain statements made in this news release contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and 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. Forward-looking statements in this news release may address the following subjects among others: statements regarding future results under our joint development and license agreement with MD Anderson, the development or commercialization of lung cancer screening or diagnostic products, the sufficiency of our capital resources, our ability to secure favorable reimbursement rates from Medicare and other third-party payors, timing of our development or launch of a commercial product, our estimates of available market sizes and our potential penetration, expected research and development expenses, expected general and administrative expenses and our expectations concerning our business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those 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 urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

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