Newly Published Data from National Study Supports Interpace Diagnostics’ PancraGEN®
November 26 2018 - 6:55AM
New Article in Peer-Reviewed Journal Highlights
Important Role of PancraGEN®
Testing
Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) announced
today a new scientific paper was published and the primary
conclusion showed that DNA analysis using PancraGEN® has a
favorable impact on patient outcomes particularly in patients with
cysts that have worrisome features supporting more accurate surgery
and surveillance decisions. The paper entitled “The Incremental
Value of DNA Analysis in Pancreatic Cysts Stratified by Clinical
Risk Factors” was published in the November edition of
Gastrointestinal Endoscopy, the official peer-reviewed publication
of the American Society for Gastrointestinal Endoscopy. The three
DNA abnormalities examined in the study, all of which are included
in the PancraGEN® assay, included: elevated DNA quantity, KRAS
mutation, and loss of heterozygosity (LOH) mutations among a panel
of key tumor suppressor genes.
The authors of the article included Dr. James Farrell of Yale
University, Dr. Mohammad Al-Haddad of Indiana University, and Dr.
Tamas Gonda of Columbia University and the study assessed a total
of 478 patients. Of this cohort, 209 had surgical pathology derived
outcomes and 269 had clinical follow up of 2 to 8 years. Among
patients with worrisome cysts, the presence of multiple DNA
abnormalities significantly increased risk of malignancy and the
absence of all DNA abnormalities significantly decreased risk to
very low levels. Importantly, the absence of all DNA abnormalities
deescalated risk in 50% of worrisome cysts, which is consistent
with other reports concluding that ancillary DNA testing alters
decisions for surgery in 54% of cases in which there are
intermediate levels of concern; 79% of such decisions favored
observation rather than surgery (Arner DM et al, Endosc Ultrasound
2018;7:29-33).
Jack Stover, President and CEO of Interpace, stated, “This newly
published study representing nearly 500 patients authored by these
luminaries from such highly respected institutions in a top tier
peer reviewed journal provides the most important evidence to date
that the use of PancraGEN® can significantly improve outcomes in
targeted patient populations.”
About PancraGEN® and PanDNA®
PancraGEN® is a molecular, cancer risk classifier for cysts,
solid lesions, and biliary strictures that have potential for
pancreatic or bile duct cancer and that by using a small sample of
fluid or duct brush, can aid in cancer risk assessment. PancraGEN®
is 90% accurate according to clinical studies, enabling effective
risk stratification of patients with pancreatic cysts and has been
used in over 40,000 cysts since its commercial launch. PancraGEN®
utilizes integrated molecular pathology (IMP) which incorporates
clinical and imaging data, Carcinoembryonic Antigen (CEA) and
Amylase values, and multiple molecular markers evaluated using DNA
sequencing. All elements are reviewed my molecular pathologists who
assign each case a clinical risk stratification ranging from benign
to malignant depending on the aggregate assessment encompassing all
of these factors. The Company also now offers a ‘molecular only’
version of PancraGEN® called PanDNA® that only reports the
molecular results, enabling clients to conduct their own
comprehensive clinical risk assessment based on DNA abnormalities
tested by PancraGEN®.
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; ThyGenX® 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. BarreGEN®, for Barrett's Esophagus,
is currently being “soft launched” with key opinion leaders as we
continue to gather data on this assay that will assist us in
seeking favorable reimbursement as well as important clinical
information. Barrett's Esophagus is a rapidly growing diagnosis
that affects over three million people in the US, and over time can
progress to esophageal cancer. 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 20 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 and its ability to maintain its NASDAQ
listing. 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 / Andrew
Gibson646-653-7030 / 7719jgreen@edisongroup.com/
agibson@edisongroup.com
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