Interpace Biosciences Announces Collaborative Study with University of North Carolina to Assess the Use BarreGEN® after Abla...
January 06 2020 - 6:55AM
Interpace Biosciences, Inc. (Nasdaq: IDXG), a leader in
enabling personalized medicine, today announced that the Company’s
wholly-owned subsidiary, Interpace Diagnostics has entered into a
collaborative study aimed at exploring the potential use of
BarreGEN® in patients undergoing radiofrequency ablation (RFA). RFA
is typically known as a cancer preventative therapy that either
delays or arrests the progression of Barrett’s Esophagus to
esophageal cancer. Evidence to date suggests that BarreGEN® may
identify non-dysplastic Barrett’s Esophagus patients in need of
ablation, making targeted ablation a potentially cost-effective
treatment option. This new collaborative study performed in
partnership with the University of North Carolina Division of
Gastroenterology under the direction of Nick Shaheen, MD MPH, using
the BarreGEN® assay developed by Interpace aims to target the
potential for molecular changes to predict resistance or relapse
following RFA.
The study is a prospective, single site study
which will be performed using BarreGEN® and targeted to evaluate
approximately 60 patients with dysplastic Barrett’s undergoing RFA.
Use of BarreGEN® may allow clinicians to adjust ablative protocols
providing optimal treatment response and improved patient outcome.
The assay may also aid in recognition of patients at risk for
recurrence of Barrett’s after initially successful ablation. The
study is expected to begin enrolling patients early in the first
quarter of 2020 with the hope of readout later in the year.
Historically, BarreGEN® has been evaluated under
a Clinical Experience Program (or CEP) and has been used only by
patients with non-dysplastic Barrett’s Esophagus to help physicians
assess the risk of progression to esophageal cancer to enable
optimal management decisions. This new study will evaluate the
ability of BarreGEN® results to predict RFA treatment resistance in
patients with dysplastic Barrett’s and the need for additional or
alternative intervention.
“We look forward to reporting the results of
this novel study that will combine Interpace’s molecular expertise
in Barrett’s with UNC’s clinical and research expertise” said Jack
Stover, CEO of Interpace Biosciences. He continued “We believe this
is another important step in bringing our BarreGEN® test more
broadly to the market to potentially modify treatment plans that
can improve patient outcomes. Defining the value of BarreGEN® in
this new patient population may give clinicians a new use for this
powerful assay.”
About Interpace Biosciences
Interpace Biosciences is a leader in enabling
personalized medicine, offering specialized services along the
therapeutic value chain from early diagnosis and prognostic
planning to targeted therapeutic applications.
Interpace Diagnostics is a fully integrated
commercial and bioinformatics business unit that provides
clinically useful molecular diagnostic tests, bioinformatics and
pathology services for evaluating risk of cancer by leveraging the
latest technology in personalized medicine for improved patient
diagnosis and management. Interpace has four commercialized
molecular tests and one test in a clinical evaluation process
(CEP): PancraGEN® for the diagnosis and prognosis of pancreatic
cancer from pancreatic cysts; ThyGeNEXT® for the diagnosis of
thyroid cancer from thyroid nodules utilizing a next generation
sequencing assay; ThyraMIR® for the diagnosis of thyroid cancer
from thyroid nodules utilizing a proprietary gene expression assay;
and RespriDX® that differentiates lung cancer of primary vs.
metastatic origin. In addition, BarreGEN® for Barrett’s Esophagus,
is currently in a clinical evaluation program whereby we gather
information from physicians using BarreGEN® to assist us in
positioning the product for full launch, partnering and potentially
supporting reimbursement with payers.
Interpace Pharma Solutions provides
pharmacogenomics testing, genotyping, biorepository and other
customized services to the pharmaceutical and biotech industries
while also advancing personalized medicine by partnering with
pharmaceutical, academic, and technology leaders to effectively
integrate pharmacogenomics into their drug development and clinical
trial programs with the goals of delivering safer, more effective
drugs to market more quickly, and improving patient care.
For more information, please visit Interpace
Biosciences’ website at www.interpace.com.
About BarreGEN®
BarreGEN® is a molecular based assay performed
on esophageal specimens from patients with Barrett’s esophagus to
help assess risk of progression to esophageal cancer. Barrett’s
esophagus, often diagnosed in patients with long standing
gastroesophageal reflux disease, is a known risk factor for
esophageal cancer. BarreGEN® analysis quantifies mutational load
providing an indication of cumulative genomic instability.
Understanding future risk of progression to esophageal cancer based
on genomic changes can help limit unnecessary repeat endoscopies in
patients with low risk and justify more aggressive management, such
as ablative therapy or surgery, in patients with higher risk.
About Dr. Nicholas Shaheen
Nicholas Shaheen, MD MPH is Chief of the
Division of Gastroenterology & Hepatology University of North
Carolina School of Medicine, Chapel Hill. As a prominent
gastroenterologist and epidemiologist, Dr. Shaheen has been awarded
the Bozymski-Heizer Distinguished Professorship at the University
of North Carolina School of Medicine. He has authored more than 400
papers and book chapters with focus on pre-cancerous and cancerous
conditions of the esophagus, as well as esophageal motility
disorders and reflux disease.
Dr. Shaheen is well known for his groundbreaking
research on Barrett’s esophagus. A major theme of his research has
been developing and testing new endoscopic methods for treatment of
patients with Barrett’s. He was the principal investigator of a 19
center U.S. trial of radiofrequency ablation for dysplastic
Barrett’s esophagus, demonstrating the efficacy and safety of this
procedure. The paper was published in the New England Journal of
Medicine. He was also the lead investigator of a 10-center study
defining the efficacy of cryotherapy in subjects with Barrett’s and
high-grade dysplasia. These endoscopic technologies have
fundamentally changed the care of patients with early esophageal
neoplasia. He is also a member of several consortia that are
conducting translational studies of Barrett’s patients.
Forward-looking Statements
This press release contains forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and the
Private Securities Litigation Reform Act of 1995, relating to the
Company's future financial and operating performance. The Company
has attempted to identify forward looking statements by terminology
including "believes," "estimates," "anticipates," "expects,"
"plans," "projects," "intends," "potential," "may," "could,"
"might," "will," "should," "approximately" or other words that
convey uncertainty of future events or outcomes to identify these
forward-looking statements. These statements are based on current
expectations, assumptions and uncertainties involving judgments
about, among other things, future economic, competitive and market
conditions and future business decisions, all of which are
difficult or impossible to predict accurately and many of which are
beyond the Company's control. These statements also involve known
and unknown risks, uncertainties and other factors that may cause
the Company's actual results to be materially different from those
expressed or implied by any forward-looking statement.
Additionally, all forward-looking statements are subject to the
“Risk Factors” detailed from time to time in the Company's most
recent Annual Report on Form 10-K and Quarterly Reports on Form
10Q. Because of these and other risks, uncertainties and
assumptions, undue reliance should not be placed on these
forward-looking statements. In addition, these statements speak
only as of the date of this press release and, except as may be
required by law, the Company undertakes no obligation to revise or
update publicly any forward-looking statements for any reason.
CONTACTS:Investor Relations - Edison
GroupJoseph Green(646) 653-7030jgreen@edisongroup.com
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