Interpace Diagnostics Group, Inc. (NASDAQ:IDXG) (“Interpace” or
“the Company”), a fully integrated commercial company that provides
clinically useful molecular diagnostic tests and pathology services
for improved patient diagnosis and management, today announced that
the Company has entered into a Laboratory Services Agreement with
ARUP Laboratories, Inc. (ARUP), of Salt Lake City, Utah, whereby
ARUP is utilizing Interpace Diagnostics as a laboratory services
provider for its menu of molecular testing services. ARUP is a
national reference laboratory with one of the broadest test menus
in the industry. Terms of the Agreement were not disclosed.
ARUP offers comprehensive diagnostic laboratory testing to a
wide array of customers including hospitals, hospital groups,
commercial laboratories, GPO’s, and large clinics among others.
Jack E. Stover, President and CEO of Interpace Diagnostics
stated, “We are pleased that an organization with a reputation as
strong as ARUP’s is making our molecular tests available to their
customers. This new contract represents an opportunity to further
expand our reach to providers nationwide.”
About Thyroid Nodules, ThyGenX and ThyraMIR
testing
According to the American Thyroid Association,
approximately 15% to 30% of the 525,000 thyroid fine needle
aspirations (FNAs) performed on an annual basis in the U.S. are
indeterminate for malignancy based on standard cytological
evaluation, and thus are candidates for ThyGenX and ThyraMIR.
ThyGenX and ThyraMIR reflex testing yields high predictive value
in determining the presence and absence of cancer in thyroid
nodules. The combination of both tests can improve risk
stratification and surgical decision-making when standard
cytopathology does not provide a clear diagnosis for the presence
of cancer.
ThyGenX utilizes state-of-the-art next-generation sequencing
(NGS) to identify more than 100 genetic alterations associated with
papillary and follicular thyroid carcinomas, the two most common
forms of thyroid cancer.
ThyraMIR is the first microRNA gene expression
classifier. MicroRNAs are small, non-coding RNAs that bind to
messenger RNA and regulate expression of genes involved in human
cancers, including every subtype of thyroid cancer. ThyraMIR
measures the expression of 10 microRNAs. Both ThyGenX and
ThyraMIR are covered by both Medicare and Commercial insurers.
About PancraGEN®
PancraGEN® is a molecular test for pancreatic cysts that
stratifies cysts based on numerous factors including cytology,
amylase, CEA, imaging, and molecular including loss of
heterozygosity,(LOH), tumor suppressor genes, and DNA quantity and
quality. Using a small sample of pancreatic cyst fluid,
PancraGen can aid in pancreatic cancer risk assessment. PancraGEN®
is 90% accurate according to clinical studies, enabling effective
risk stratification of patients. Pancreatic cancer is often
difficult to diagnose in early stages and typically spreads rapidly
with signs and symptoms appearing when the cancer is significantly
advanced. Because of this, and the fact that complete surgical
removal of the pancreas is not possible, pancreatic cancer is
considered a leading cause of cancer deaths. Pancreatic
cancer generally affects older patients. PancraGen is covered
by Medicare.
About RespriDx™
RespriDx differentiates local recurrence of cancer versus new
primary cancer formation. It compares the mutational
fingerprint of two or more sites of cancer to determine whether the
neoplastic deposits are representative of a recurrence of cancer or
a new primary (independent) cancer. RespriDx helps define the
primary site of formation in relationship to multiple sites of
metastatic spread and helps differentiate multi-centric carcinoma
from intra-organ spread of one cancer. The test is based on an
analysis of loss of heterozygosity using a panel of microsatellite
markers in proximity to 16 tumor suppressor genes. Various peer
reviewed publications support the use of mutational profiling for
this purpose including “Comparative Mutational Profiling in the
Assessment of Lung Lesions: Should it be the Standard of Care?”
(Annals of Thoracic Surgery, 2010). RespriDx is covered
by numerous payers.
About BarreGen®
Interpace Diagnostics' BarreGen test utilizes the PathFinderTG®
platform, which assesses loss of heterozygosity and microsatellite
instability mutations of multiple tumor suppressor genes. BarreGen
summarizes this genomic instability information as the Mutational
Load, enabling physicians to more accurately stratify patients with
Barrett's esophagus for risk of progression to dysplasia and
cancer. This can allow for more personalized management of the
disease, including early intervention to decrease likelihood of the
progression to cancer. All patients with Barrett's esophagus
are ideal candidates for testing with BarreGen.
About Interpace Diagnostics Group,
Inc.
Interpace Diagnostics is a company that provides clinically
useful molecular diagnostic tests and pathology services for
evaluating risk of cancer by leveraging the latest technology in
personalized medicine for better patient diagnosis and management.
The Company currently has four commercialized molecular tests;
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 which
differentiates local recurrence of lung cancer verses new primary
cancer formation. Interpace Diagnostics' mission is to
provide personalized medicine through molecular diagnostics and
innovation to advance patient care based on rigorous science.
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. Known and
unknown risks, uncertainties and other factors include, but are not
limited to, the Company's ability to adequately finance the
business, its ability to restructure its liabilities and other
obligations, 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 most recent Annual
Report on Form 10-K and Quarterly Reports on Form 10-Q.
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 Relations:Paul
Kuntzpaul@redchip.com
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