Exact Sciences Announces Norton Healthcare to Adopt Cologuard

First and only FDA-approved noninvasive stool DNA screening test for colorectal cancer

MADISON, Wis.--()--Exact Sciences Corp. (NASDAQ: EXAS) today announced Norton Healthcare is the first healthcare system in Kentucky to offer Cologuard®, the first and only FDA-approved noninvasive stool DNA screening test for colorectal cancer. Cologuard makes it easy for average risk patients 50 years and older to get screened at their convenience and in the privacy and comfort of their own home without having to worry about taking time off work to prepare for an invasive procedure.

“Norton Healthcare is proud to be the first healthcare provider in Kentucky to offer this important new advancement that can help increase screening compliance for colon cancer,” said Dr. Thomas Woodcock, an Oncology Specialist with the Norton Healthcare Cancer Institute. “The decision to offer this at-home screening tool reflects the commitment of the Norton Cancer Institute to lead the way in innovative cancer care and prevention.”

Cologuard is approved for those who are age 50 and over, and have average risk for colon cancer (no prior history with polyps or cancer, and no family history with colon cancer). A physician’s prescription is required for the test, which analyzes a person’s stool to detect both altered DNA and blood known to be associated with colorectal cancer or pre-cancer.

Colorectal cancer is the second-leading cancer-related cause of death in the United States. It is often considered a highly preventable cancer, yet is the least prevented cancer due to the lack of patient compliance with current screening options. Most colorectal cancers develop slowly over several years. Before cancer develops, a polyp—a non-cancerous growth—usually appears on the inner lining of the colon or rectum. Identifying and removing these polyps, through routine screenings, can effectively prevent colorectal cancer. For those whose cancer is detected at an early stage, the five-year survival rate can be greater than 90 percent, making routine screening critical. Unfortunately, 23 million Americans aged 50 and over do not get screened as recommended.

“The more resources you can provide that make it easier and more convenient for patients to get regular colon cancer screenings, the more opportunity we have to improve early detection and survival rates for this preventable cancer,” said Robert W. Shaw, M.D., Norton Community Medical Associates.

After the healthcare provider orders Cologuard, the test is delivered directly to the patient’s home. The patient collects a stool sample in the collection container provided and sends the test back to the lab for testing using a pre-paid mailer. Results are turned around in as little as two weeks and patients learn their results from their healthcare provider. Any positive result is communicated by a personal phone call to the ordering physician, who will inform the patient. A positive result should be followed by a diagnostic colonoscopy.

"Norton Healthcare’s adoption of Cologuard provides access to an important new screening tool for colorectal cancer to a population that may otherwise never get screened," said Kevin Conroy, President, CEO and Chairman of Exact Sciences. "Colon cancer is very treatable when caught early, making compliance with screening even more critical. We look forward to working with the healthcare providers at Norton toward a future where colorectal cancer is survived more often."

Cologuard was approved by the FDA in August 2014. Results from Exact Sciences’ prospective 90-site, point-in-time 10,000-patient pivotal trial—one of the most extensive colorectal cancer screening studies ever conducted in the United States by a device manufacturer—were published in March 2014 in the New England Journal of Medicine: “Multi-target Stool DNA Testing for Colorectal-Cancer Screening.”

For more information about Cologuard, visit www.CologuardTest.com. Individuals should talk to their doctors about their risk for colorectal cancer and which screening option is right for them. This screening tool is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. Both false positives and false negatives are possible.

Additional Story Resources:

  • Interview opportunities available with several different physicians.
  • B-roll, a test animation and a demonstration test provided by Exact Sciences are available for photo or video use.

About Norton Healthcare

For 128 years, Norton Healthcare’s faith heritage has guided its mission to provide quality health care to all those it serves. Today, Norton Healthcare is a leader in serving adult and pediatric patients throughout Greater Louisville, Southern Indiana, the commonwealth of Kentucky and beyond. The hospital and healthcare system is the Louisville area’s third largest private employer, providing care at more than 140 locations throughout Greater Louisville and Southern Indiana. The Louisville-based not-for-profit system includes five Louisville hospitals with 1,837 licensed beds; seven outpatient centers; 12 Norton Immediate Care Centers; nearly 12,000 employees; nearly 700 employed medical providers; and approximately 2,000 total physicians on its medical staff. In 2014 Norton Healthcare was named by Healthiest Employers as the seventh healthiest place to work in the country. More information about Norton Healthcare is available at NortonHealthcare.com.

About Exact Sciences Corp.

Exact Sciences Corp. (NASDAQ: EXAS) is a molecular diagnostics company focused on the early detection and prevention of colorectal 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 listed in the screening guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer. For more information, please visit the company's website at www.exactsciences.com, 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 the sufficiency of our capital resources, our ability to secure favorable reimbursement rates from Medicare and other third-party payors, timing of our launch of a commercial product, our estimates of the available market size 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.

Contacts

Media Contact for Exact Sciences:
MSLGROUP
(781) 684-0770
exactsciences@mslgroup.com.com
or
Media Contact for Norton Healthcare:
Menisa Marshall, Public Relations Project Mgr.
502-629-8677 (office) / 502-551-2048 (cell)
Menisa.marshall@nortonhealthcare.org
General PR On-Call Line: 502-629-2999

Contacts

Media Contact for Exact Sciences:
MSLGROUP
(781) 684-0770
exactsciences@mslgroup.com.com
or
Media Contact for Norton Healthcare:
Menisa Marshall, Public Relations Project Mgr.
502-629-8677 (office) / 502-551-2048 (cell)
Menisa.marshall@nortonhealthcare.org
General PR On-Call Line: 502-629-2999