Company asserts that Geneoscopy infringed
patented technology central to its Cologuard colorectal cancer
screening test
MADISON,
Wis., Nov. 17, 2023 /PRNewswire/ -- Exact
Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer
screening and diagnostic tests, today announced that it has filed a
lawsuit against Geneoscopy, Inc. in the United States District Court for the District
of Delaware. The lawsuit seeks
damages and a court order to stop Geneoscopy from making, using,
selling, or offering for sale Geneoscopy's ColoSense product or
otherwise infringing on Exact Sciences' U.S. Patent No. 11,634,781
("the '781 Patent"). The filed complaint can be accessed on the
Exact Sciences' website.
Exact Sciences utilizes the patented '781 technology in its
Cologuard® stool DNA-based colorectal cancer screening test. The
patent covers clinically important methods for processing
collection of fecal samples at home, in a manner that preserves the
integrity of biomarkers contained in the sample to allow for
subsequent analysis in a clinical laboratory.
After receiving a cease-and-desist letter from Exact Sciences
regarding its patent infringement, Geneoscopy requested
a reexamination of the '781 patent by the United States Patent
and Trademark Office (USPTO) in May 2023. Upon completion of
the reexamination in October 2023,
the USPTO rejected Geneoscopy's challenge, confirming the
patentability of all claims of the '781 patent for Exact
Sciences.
"Exact Sciences pioneered a significant scientific breakthrough
that has touched millions of patient lives. We worked tirelessly to
develop Cologuard, a first-of-its-kind diagnostic that has been
used to screen for colorectal cancer more than 13 million
times," said Kevin Conroy,
chairman and CEO of Exact Sciences. "As a company deeply rooted in
innovation, we understand the vital role of intellectual property,
and we will vigorously defend our patents."
Since 2009, Exact Sciences has invested hundreds of millions to
study Cologuard and at-home cancer screening technology in 26
clinical trials that included 256,000 participants. The
company holds more than 70 U.S. and over 140 internationally issued
Cologuard patents, with more than 80 patent applications pending
worldwide.
About Cologuard
Results from Exact Sciences'
prospective, 90-site, point-in-time, 10,000-patient pivotal trial,
DeeP-C, were published in the New England Journal of Medicine in
March 2014. The Cologuard test is
included in the American Cancer Society's (2018) colorectal cancer
screening guidelines and the recommendations of the U.S. Preventive
Services Task Force (2021) and National Comprehensive Cancer
Network (2023). The Cologuard test is indicated to screen adults 45
years of age and older who are at average risk for colorectal
cancer by detecting certain DNA markers and blood in the stool. Do
not use the Cologuard test if you have had precancer, have
inflammatory bowel disease and certain hereditary syndromes, or
have a personal or family history of colorectal cancer. The
Cologuard test is not a replacement for colonoscopy in high-risk
patients. The Cologuard test performance in adults ages 45-49 is
estimated based on a large clinical study of patients 50 and older.
The Cologuard test performance in repeat testing has not been
evaluated.
The Cologuard test result should be interpreted with caution. A
positive test result does not confirm the presence of cancer.
Patients with a positive test result should be referred for
colonoscopy. A negative test result does not confirm the absence of
cancer. Patients with a negative test result should discuss with
their doctor when they need to be tested again. Medicare and most
major insurers cover the Cologuard test. For more information about
the Cologuard test, visit cologuard.com. Rx only.
About Exact Sciences Corp.
A leading provider of
cancer screening and diagnostic tests, Exact Sciences gives
patients and health care professionals the clarity needed to take
life-changing action earlier. Building on the success of the
Cologuard® and Oncotype® tests, Exact Sciences is investing in its
pipeline to develop innovative solutions for use before, during,
and after a cancer diagnosis. For more information, visit
ExactSciences.com, follow Exact Sciences on X (formerly known as
Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and
Facebook.
Forward-Looking Statement
This news release contains
forward-looking statements concerning our expectations,
anticipations, intentions, beliefs or strategies regarding the
future. These forward-looking statements are based on
assumptions that we have made as of the date hereof and are subject
to known and unknown risks and uncertainties that could cause
actual results, conditions, and events to differ materially from
those anticipated. For example, there can be no assurance as to
developments related to the litigation, the outcome of the
litigation, or remedies that could be awarded in connection with
the litigation; our ability to establish or maintain our
intellectual property and other proprietary rights; our business,
IP, or legal strategies; or our ability to successfully and
profitably market our current products or services or bring new
products or services to market. Therefore, you should not place
undue reliance on forward-looking statements. Risks and
uncertainties that may affect our forward-looking statements are
described in the Risk Factors sections of our most recent Annual
Report on Form 10-K and any subsequent Quarterly Reports on Form
10-Q, and in our other reports filed with the Securities and
Exchange Commission. 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.
Investor
Contact:
Erik Holznecht
Exact Sciences Corp.
investorrelations@exactsciences.com
608-800-6605
Media Contact:
Morry
Smulevitz
Exact Sciences Corp.
msmulevitz@exactsciences.com
608-345-8010
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SOURCE EXACT SCIENCES CORP