Interpace Diagnostics Announces First Independent Publication Demonstrating Clinical Utility of BarreGEN®
February 19 2019 - 6:55AM
Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) announced
today that BMJ Open Gastroenterology, an on-line, peer-reviewed,
open access gastroenterology journal dedicated to publishing
high-quality medical research from all disciplines and therapeutic
areas of gastroenterology, has provided the first independent
evidence that BarreGEN®, the Company’s lead pipeline product,
performed effectively as a biomarker tool for predicting risk of
developing more advanced stages of disease prior to the visible
appearance of advanced histology. This is the first publication
resulting from work related to the Company’s ongoing Clinical
Experience Program (CEP) under which several sites across the
country are using BarreGEN to provide input on its clinical utility
in a real-world setting. Other sites are expected to report on
their results and optimally have them published in similar fashion
over the next several months. The study entitled “Mutational Load
May Predict Risk of Progression in Patients with Barrett’s
Esophagus and Indefinite for Dysplasia: A Pilot Study” was
conducted at the Division of Gastroenterology, Zucker School of
Medicine at Hofstra/Northwell, Long Island Jewish Medical Center,
Northwell Health System, New Hyde Park, New York and the authors
were Trindade AJ, McKinley MJ, and Alshelleh M., et. al.
Management of Barrett’s Esophagus patients who
have indefinite levels of dysplasia is challenging due to
uncertainty in their risk of progressing to more advanced disease,
such as low or high-grade dysplasia. In past studies, BarreGEN’s
assessment for genomic instability has been shown to help identify
the presence of dysplasia and, moreover, to identify Barrett’s
patients at higher risk of developing high grade dysplasia and
cancer 4 years prior to visible signs of advanced histology.
Findings from this clinical experience study further support the
use of BarreGEN as an effective tool at identifying higher risk of
progression in patients with indefinite levels of dysplasia at
least a year prior to the appearance of dysplasia. They support the
use of BarreGEN as a biomarker to identify Barrett’s patients in
need of closer surveillance or cancer preventative measures,
differentiating them from those in whom unnecessary interventions
can be avoided.
In the study, genomic instability was examined
using BarreGEN’s mutation load assessment in twenty-eight
consecutive patients of whom eight progressed to dysplasia.
Mutational load was 100% sensitive and 85% specific in identifying
Barrett’s patients as indefinite for dysplasia who would later
develop high grade dysplasia. Higher mutational load levels
escalated risk of developing high grade dysplasia to 33% and risk
of developing any dysplasia to 41%. Comparably, patients who had
lower mutational load levels were at less than 10% risk of
developing any dysplasia and at 0% of developing high grade
dysplasia. Accordingly, these results are supportive of mutational
load as a useful biomarker that can help risk-stratify patients
with indefinite for dysplasia where risk of advanced disease is
more uncertain and additional information is needed to help triage
patients.
Jack Stover, President and CEO of Interpace,
stated, “We are pleased that such a prestigious institution has
published this peer-reviewed study providing the first independent
evidence of the clinical utility of BarreGEN in identifying those
patients who are likely to progress from Barrett’s Esophagus to
more advanced stages of the disease associated with cancer.” Mr.
Stover continued, “We are looking forward to additional study
results being announced in the near future from our growing CEP
related to the performance of BarreGEN in more real-world
settings.”
About Interpace Diagnostics Group, Inc.
Interpace is a fully integrated commercial and
bioinformatics company that provides clinically useful molecular
and related first line diagnostic tests and pathology services for
evaluating risk of cancer by leveraging the latest technology in
personalized medicine for improved patient diagnosis and
management. The Company currently 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. The Company’s data base includes data from over
45,000 patients who have been tested using the Company’s current
products, including over 15,000 molecular tests for thyroid
nodules. Interpace has been designated by CIO Applications magazine
as one of the top 10 companies for providing bioinformatics
solutions. Interpace’s mission is to provide personalized medicine
through molecular diagnostics, innovation and data to advance
patient care based on rigorous science. For more information,
please visit Interpace’s website at
www.interpacediagnostics.com
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, 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. Known
and unknown risks, uncertainties and other factors include, but are
not limited to, the Company’s history of losses, the Company's
ability to adequately finance the business, the market's acceptance
of its molecular diagnostic tests, its ability to retain or secure
reimbursement, its ability to secure additional business and
generate higher profit margins through sales of its molecular
diagnostic tests, in-licensing or other means, projections of
future revenues, growth, gross profit and anticipated internal rate
of return on investments, its ability to maintain its NASDAQ
listing and the Company’s ability to successfully commercialize
BarreGENÒ including collecting clinical data and obtaining
reimbursement. Additionally, all forward-looking statements are
subject to the “Risk Factors” detailed from time to time in the
Company's SEC filings, including its Annual Report on Form 10-K for
the fiscal year ended December 31, 2017, filed on March 23, 2018,
Quarterly Reports on Form 10-Q and other SEC filings. 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:Interpace DiagnosticsInvestor
RelationsJoseph Green / Wiktoria O’Hare646-653-7030 /
7028jgreen@edisongroup.com/ wohare@edisongroup.com
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