SAN DIEGO, May 20, 2019 /PRNewswire/ -- Early research
using blood-based methylated DNA markers, identified through the
longstanding collaboration between Exact Sciences and Mayo Clinic,
demonstrates a potential to achieve 92% sensitivity and 92%
specificity for detecting the most common type of pancreatic
cancer. Researchers presented the findings at Digestive Disease
Week (DDW) 2019, the largest international gathering of physicians,
researchers and academics in the fields of gastroenterology,
hepatology, endoscopy and gastrointestinal surgery.
"These pancreatic cancer data showcase the strength of our
marker discovery collaboration with Mayo Clinic, a partnership that
is fueling our product pipeline," said Kevin Conroy, chairman and CEO of Exact
Sciences. "We aim to identify a minimally-invasive marker for a
disease that often goes undetected until it progresses to an
advanced stage, when fewer treatment options exist."
Pancreatic cancer is the third-leading cause of cancer-related
deaths in the United States.
According to the American Cancer Society, half of all pancreatic
cancer patients are diagnosed in later stages when the five-year
median survival rate is only 3%. No major guidelines recommend
routine screening for average risk patients because the current
detection options have not shown to lower a patient's risk of
death.
Lead author and Mayo Clinic gastroenterologist Shounak Majumder, M.D. presented results from
the 340-sample, case-control study. A panel of methylated DNA
markers in plasma in combination with CA 19-9, achieved a
cross-validated sensitivity of 79% in Stage 1, 82% in Stage 2, 94%
in Stage 3 and 99% in Stage 4 pancreatic ductal adenocarcinoma
(PDAC) with 92% specificity (81-100%). This combination was
significantly better than CA 19-9 alone. As Majumder writes in the
abstract, "CA 19-9 is unreliable for early detection and may be
normal in advanced disease."
Statistical modeling was used to identify the best algorithm to
predict disease status in this sample set. Subsequently, the panel
was cross validated by randomly splitting the entire data set into
training and testing sets. The fitted model from the training set
was used to predict disease status in the test set over multiple
iterations. This study used a small number of archival patient
blood samples, which could lead to over-fitting to this particular
sample set and cause subsequent sensitivity and specificity to
decline in a larger, prospective population. A prospective
validation study is currently underway at Mayo Clinic.
"Powered by more than a decade of work with Exact Sciences, Mayo
Clinic researchers continue producing promising data, in this case
on blood-based biomarkers for pancreatic cancer detection," said
Paul Limburg, MD, MPH,
AGAF, Exact Sciences chief medical officer and Mayo Clinic
gastroenterologist.i "While further research must be
completed, this serves as an early indicator of encouraging news in
the fight against this deadly disease."
The Exact Sciences and Mayo Clinic collaboration focuses on
identifying biomarkers for 15 of the deadliest cancers. A poster
showing Mayo Clinic researchers work on esophageal cancer will also
be presented at DDW.
About Exact Sciences Corp.
Exact Sciences Corp. is a
molecular diagnostics company focused on the early detection and
prevention of some 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 ExactSciences.com, follow Exact Sciences on Twitter
@ExactSciences or find Exact Sciences on Facebook.
About Cologuard
Cologuard was approved by the FDA in
August 2014 and results from Exact
Sciences' prospective 90-site, point-in-time, 10,000-patient
pivotal trial were published in the New England Journal of Medicine
in March 2014. Cologuard is included
in the American Cancer Society's (2018) colorectal cancer screening
guidelines and the recommendations of the U.S. Preventive Services
Task Force (2016) and National Comprehensive Cancer Network (2016).
Cologuard is indicated to screen adults of either sex, 50 years or
older, who are at average risk for colorectal cancer. Cologuard is
not for everyone and is not a replacement for diagnostic
colonoscopy or surveillance colonoscopy in high-risk individuals,
including those with a history of colorectal cancer and advanced
adenoma, a family history of colorectal cancer, IBD or certain
hereditary syndromes. False positives and false negatives do occur.
Any positive test result should be followed by a diagnostic
colonoscopy. Following a negative result, patients should continue
participating in a screening program at an interval and with a
method appropriate for the individual patient. Cologuard
performance when used for repeat testing has not been evaluated or
established. Medicare and most major insurers cover Cologuard. For
more information about Cologuard, visit CologuardTest.com Rx
Only.
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About Digestive Disease Week
Digestive Disease
Week® (DDW) is the largest international gathering of
physicians, researchers and academics in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. Jointly sponsored by the American Association for the
Study of Liver Diseases (AASLD), the American Gastroenterological
Association (AGA) Institute, the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of
the Alimentary Tract (SSAT), DDW takes place May 18-21, 2019, at the San Diego Convention Center. The meeting
showcases more than 5,000 abstracts and hundreds of lectures on the
latest advances in GI research, medicine and technology. More
information can be found at www.ddw.org.
Media Contact:
Cara
Connelly
Exact Sciences Corp.
cconnelly@exactsciences.com
614-302-5622
Investor Contact:
Megan
Jones
Exact Sciences Corp.
meganjones@exactsciences.com
608-535-8815
i Mayo Clinic and Dr. Limburg have a financial
interest related to the technology referenced in this press
release. Mayo Clinic will use any revenue it receives to support
its not-for-profit mission in patient care, education and
research.
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