Interpace Diagnostics Corp. (NASDAQ:IDXG), a fully integrated
commercial company that provides clinically useful molecular
diagnostic tests and pathology services for improved patient
diagnosis and management, announced today that the New York State
Department of Health has reviewed and approved for marketing the
Company’s TERT service offering, which can be ordered in
conjunction with the Company’s ThyGenX molecular panel or on a
stand-alone basis. While the Company currently markets both
ThyGenX and ThyraMIR® in New York State, until now the TERT
offering has been awaiting New York State approval. The TERT
marker is a strong molecular predictor of the aggressiveness of
thyroid cancer and adds additional insights into a patient’s
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
not only acts as a strong predictor of thyroid cancer, but also
provides evidence that a positive result indicates the cancer is
more likely to be more aggressive, enabling physicians to make the
most informed surgical choice possible. The Company currently
provides ThyGenX and ThyraMIR testing to over 250 hospitals and 500
physicians nationwide. The Company has performed over 15,000
ThyGenX/ThyraMIR tests and recently presented data at the American
Thyroid Association’s Annual Meeting in Vancouver, British Columbia
using data from this patient cohort demonstrating the performance
of these assays in a real world clinical setting.
According to Jack Stover, President and CEO of Interpace
Diagnostics, “The addition of TERT to our ThyGenX assay is a
potential game changer given the fact that no other diagnostics
company has been able to successfully incorporate the TERT
biomarker into a combination testing algorithm product offering.
Further, TERT is well recognized as one of the most aggressive
biomarkers for thyroid cancer. The prompt recognition and approval
by New York State is a strong indication of the importance of
making this vital insight available to New York State’s residents,
patients and physicians.”
About TERT
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
has been shown to dramatically increase the risk of thyroid cancer
aggressiveness, tumor recurrence, and thyroid cancer-specific
deaths.
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.
The Company first launched ThyGenX in October, 2014 and
initially launched the TERT offering in all other markets in July,
2017. ThyraMir, the Company’s miRNA based classifier, was
launched on April 15th, 2015 making it available to
Endocrinologists and Pathologists throughout the
U.S.
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. 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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