Interpace Diagnostics Presents New Data from Over 3,400 Patients Tested with ThyGenX®/ThyraMIR®
October 18 2017 - 8:45AM
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, announced
today the presentation of new data based on actual clinical results
for 3,471 patients tested with the Company’s ThyGenX® /ThyraMIR®
molecular tests for indeterminate thyroid nodules at the annual
meeting of The American Thyroid Association (ATA) being held
October 18-22, 2017 in Victoria, British Columbia. Over 5,000
Endocrinologists, Endocrine Surgeons, and numerous other providers
who focus on endocrinology attend this annual event.
The presentation at the ATA meeting is entitled
“The Utility of Combined Mutations and MicroRNA Expression
Profiling in Assessing Cancer Risk in Thyroid Nodules.” In
addition to several Company clinicians and researchers, the authors
included Dr. Jan Silverman from the Department of Pathology at
Allegheny General Hospital, Pittsburgh, PA.
The study in summary strongly supported the combined approach of
mutational panels and microRNA analysis that we use in our ThyGenX
and ThyraMIR assays. The primary conclusion reached in the study
was that mutational change is not sufficient to risk stratify
thyroid nodular disease unless accompanied by attention to
clinical, imaging and additional molecular findings and that miRNA
classification complements cytology and mutational analysis with
the capacity to better predict the biological aggressiveness of
tumors. In addition, the results supported previous conclusions
regarding the performance of combination mutational panels combined
with miRNA classifier testing based on a large cohort of patients
tested clinically in a real-world setting. Further, the data
extended prior results to include a four-tier miRNA approach that
further improves sensitivity and specificity for malignancy, which
in turn further improves the predictive value of combination
mutational panel and miRNA classifier testing. Importantly,
use of our four-tier miRNA classifier stratifies cancer risk in
patients with RAS mutations and in those who lack all
mutations, providing opportunities to further personalize
patient care.
Jack E. Stover, President and CEO of Interpace Diagnostics
stated, “We are pleased that the ATA found this new data compelling
enough to accept it for presentation during this highly regarded
conference. This data comprised of test results from a significant
number of patients is further evidence of the strong clinical
utility of ThyGenX and ThyraMIR.”
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 was the first microRNA gene
expression classifier made commercially available. 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 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 three 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 and
ThyraMIR, for the diagnosis of thyroid cancer from thyroid nodules
utilizing a proprietary gene expression assay; and MVPdx for
identifying recurring tumors in the same organ vs. metastasis from
another organ. Interpace Diagnostics' mission is to provide
personalized medicine through molecular diagnostics and innovation
to advance patient care based on rigorous science.
About the ATA
The American Thyroid Association is one of the largest specialty
physician organizations focused on enhancing the science around the
diagnosis and treatment of endocrine related diseases.
Focusing on a wide range of diseases, from diabetes to thyroid
cancer, the Association is comprised of physicians including
Endocrinologists, Endocrine Surgeons, Diabetologists,
Nutritionists, Nurse Practitioners, specialty laboratories, and
other providers.
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 Diagnostics Group, Inc.Investor
Relations:Paul Kuntz – Redchippaul@redchip.com
Interpace Biosciences (NASDAQ:IDXG)
Historical Stock Chart
From Mar 2024 to Apr 2024
Interpace Biosciences (NASDAQ:IDXG)
Historical Stock Chart
From Apr 2023 to Apr 2024