Interpace Group (NASDAQ: IDXG) Interpace Diagnostics announced
today the publication of two peer-reviewed journal articles and one
textbook chapter supporting the clinical utility of ThyGeNEXT® when
used alone and in combination with ThyraMIR®.
The most recent article was published in
Diagnostic Cytopathology in a paper called “Incremental Utility of
Expanded Mutation Panel When Used in Combination with MicroRNA
Classification in Indeterminate Thyroid Nodules”. The study is now
published on the Diagnostic Cytopathology website at
https://doi.org/10.1002/dc.24328 and compares results of ThyGenX®,
Interpace’s first-generation mutation panel, with ThyGeNEXT®,
Interpace’s expanded second-generation mutation panel, showing that
the expanded panel provides additional utility when used in
combination with ThyraMIR®, Interpace’s microRNA risk classifier.
The study concludes that expansion of the panel increases detection
of mutations and fusions strongly associated with malignancy and
aggressive thyroid cancer, increasing the panel’s utility in
surgical decision making. Furthermore, the panel expansion
also increases detection of less aggressive mutations also
associated with malignancy, where ThyraMIR® plays a key role in
providing additional risk stratification.
An independent peer-reviewed journal article has
been published in the Journal of Otolaryngology related to a study
lead by Dr. Rick Payne from McGill University, Montreal, QC,
Canada. The article entitled “Molecular Mutations as a Possible
Factor for Determining Extent of Thyroid Surgery” concluded that
markers in Interpace’s ThyGeNEXT® may be useful in identifying
aggressive thyroid tumors, assisting in the planning and timing of
surgery for patients.
In addition, Interpace’s pathologist, Dr. Tina
Narick contributed to a chapter entitled “Application of Molecular
Tests in Indeterminate Thyroid FNA” in the Atlas of Thyroid
Cytopathology on Liquid-Based Preparations. The chapter reviews the
performance and utility of molecular testing on thyroid aspirates
and specifically includes detailed information on ThyGenNEXT® and
ThyraMIR® performance, with discussion of various specimen types
including cytology slides. Importantly, it describes results
of a comparison between ThyGeNEXT® and ThyGenX®, indicating 100%
concordance between test results and the identification of
additional markers of aggressive cancer using ThyGeNEXT®,
According to Jack Stover, Interpace’s CEO,
“These publications provide further evidence of the clinical
utility of our molecular products for thyroid cancer.” In addition,
he stated, “our accumulation of data helps validate our claims with
insurance companies who are effectively the gate keepers for
patients needing our expertise.”
About Thyroid Nodules, ThyGeNEXT® and ThyraMIR®
Testing
According to the American Thyroid Association,
approximately 20% 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 ThyGeNEXT® and ThyraMIR®.
ThyGeNEXT® 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.
ThyGeNEXT® 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 ThyGeNEXT® and ThyraMIR® are covered by both
Medicare and Commercial insurers, with more than 280 million
patients covered.
About Interpace
Interpace 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’s Diagnostic Business 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’s Biopharma Business provides
pharmacogenomics testing, genotyping, biorepository and other
customized services to the pharmaceutical and biotech industries.
The Biopharma Business also advances 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’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. 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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