PARSIPPANY, N.J., May 24, 2017 /PRNewswire/ -- Interpace
Diagnostics Group, Inc. (NASDAQ: IDXG) (the "Company" or "Interpace
Diagnostics"), a fully integrated commercial company that provides
clinically useful molecular diagnostic tests and pathology services
for improved patient diagnosis, announced today that the Company is
launching a new biomarker to be ordered along with its current
molecular thyroid testing options. The TERT marker is a strong
molecular predictor of the aggressiveness of thyroid cancer and
adds additional insights in to a patients' molecular profile.
Currently, the ThyGenX™ mutation panel includes the following
markers that are predictive of thyroid cancer from cytologically
indeterminate thyroid nodules, including BRAF, HRAS, KRAS, NRAS,
RET/PTC, PAX8/PPARy, and PIK3CA. By adding TERT, the panel
will not only continue to be a strong positive predictor of thyroid
cancer, but will also provide evidence that a positive result
indicates the cancer is likely to be more aggressive in
nature.
Telomerase reverse transcriptase or TERT encodes the reverse
transcriptase component of telomerase, which adds telomere repeats
to chromosome ends, enabling cell replication. Published data
suggests that TERT mutations can extend the life span of the tumor
cell and allow time for other mutations to develop. Mutations in
the TERT promoter region are found in thyroid cancers and seem to
act synergistically when they occur with the BRAF V600
mutation. The coexistence of mutations in TERT
and BRAF genes have been shown to dramatically increase
the risk of thyroid cancer aggressiveness, tumor recurrence and
thyroid cancer-specific deaths.
Physicians will be able to order TERT as part of the ThyGenX
mutation panel or on an individual basis. To date, the
Company has performed the ThyGenX/ThyraMIR test combination assay
on over 10,000 patients on behalf of over 250 physicians and
hospitals nationwide.
ThyGenX - ThyraMIR represents the only test in the market
that combines the rule-in properties of next-generation sequencing
of a patient's DNA and RNA, with rule-out capabilities of a
micro-RNA classifier to provide physicians with clinically
actionable test results. Based on current performance, over 80% of
the Company's total cases are reflexed to ThyraMIR for additional
assessment. The Company first launched ThyGenX in October,
2014, ThyraMIR in April, 2015, and both products in the
State of NY in September, 2016,
making the combination test available to Endocrinologists and
Pathologists nationwide.
According to the American Cancer Society, thyroid cancer is the
most rapidly increasing cancer in the U.S., tripling in the past
three decades. Most physicians have traditionally recommended
thyroid surgery where thyroid nodule biopsy results are
indeterminate, not clearly benign or malignant following
traditional cytopathology review; however, 70%-80% of these
surgical outcomes are ultimately benign. Molecular testing
using ThyGenX – ThyraMIR has been shown to reduce the rate of
unnecessary surgeries in indeterminate cases.
Jack E. Stover, President and CEO
of Interpace Diagnostics stated, "We are pleased to be launching
this enhancement to our Thyroid services at the request of our
customers. This marker will provide physicians and their patients
with incremental insights into their risk for particularly
aggressive thyroid cancer."
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 yield 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 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 improved 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. 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 our future
financial and operating performance. We have 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 our control. These statements also involve known and unknown
risks, uncertainties and other factors that may cause our 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,
our ability to adequately finance our business, our ability to
restructure our liabilities and other obligations, the market's
acceptance of our molecular diagnostic tests, our ability to retain
or secure reimbursement, our ability to secure additional
business and generate higher profit margins through sales of our
molecular diagnostic tests, in-licensing or other means,
projections of future revenues, growth, gross profit and
anticipated internal rate of return on investments, and our ability
to maintain our NASDAQ listing. Additionally, all forward-looking
statements are subject to the risk factors detailed from time to
time in our periodic filings with the Securities and Exchange
Commission (SEC), including without limitation, the Annual Report
on Form 10-K related to our year ended December 31, 2016 filed with the SEC on
March 31, 2017, as amended on
April 28, 2017, and the Quarterly
Report on Form 10-Q related to our quarter ended March 31, 2017 filed with the SEC on May 12, 2017. 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, we undertake no obligation to revise or update
publicly any forward-looking statements for any reason.
CONTACTS:
Victor Roberts
RedChip Companies
407.644.4256, ext. 111
victor@redchip.com
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SOURCE Interpace Diagnostics Group, Inc.