Florida’s Largest Health Plan Adds Coverage for ThyGenX® and
ThyraMIR®
Interpace Diagnostics Group, Inc. (NASDAQ:IDXG) (“Interpace” or
“the Company”), a fully-integrated commercial and bioinformatics
company that provides clinically useful molecular diagnostic tests
and pathology services for improved patient diagnosis and
management, today announced that Blue Cross Blue Shield of Florida
(“Florida Blue”), the largest health plan in Florida, has agreed to
cover Interpace’s combination thyroid molecular-based tests,
ThyGenX® and ThyraMIR®.
Jack Stover, President and CEO of Interpace Diagnostics, stated,
“We are pleased that the largest payer in the State of Florida, and
one of the largest Blue Cross Blue Shield plans in the country, is
now covering our molecular thyroid tests.” Mr. Stover continued,
“This continues the strong trend we have seen among Blue Cross Blue
Shield plans to make our ThyGenX® - ThyraMIR® combination test
available to their members.”
Interpace’s ThyGenX® and ThyraMIR® assays are now covered for
thyroid modules deemed indeterminate by standard cytopathology
analysis for Florida Blue’s more than three million members.
Florida Blue, one of the largest independent Blue Cross plans in
the U.S., marks the 20th Blue Cross Blue Shield plan since the
beginning of 2018 to deem Interpace’s combination thyroid molecular
testing with ThyGenX® - ThyraMIR® to be medically necessary when
established criteria are met.
The ThyGenX® - ThyraMIR® combination represents the only test in
the market that includes the rule-in properties of next-generation
sequencing of the patient’s DNA and RNA along with the rule-out
capabilities of a micro-RNA classifier to provide physicians with
clinically actionable test results. Based on Interpace’s current
performance, over 90% of the Company’s ThyGenX® cases are reflexed
to ThyraMIR® for additional assessment. Interpace launched ThyGenX®
in 2014, followed by ThyraMIR® in 2015, making the combination
available to Endocrinologists and Pathologists throughout the
country. Since then, the Company has conducted over 25,000 tests
for nearly 400 physicians and hospitals nationwide. Recently, the
Company announced the launch of ThyGeNEXT™, the next generation of
ThyGenX®, providing an expanded panel that now includes markers of
aggressiveness as well as other markers that provide physicians
with incremental insights to assist in treatment decision
making.
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.
About Thyroid Nodules, ThyGenX® (now 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
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, with more than 280 million patients covered.
About Interpace Diagnostics Group
Interpace Diagnostics is a fully integrated commercial and
bioinformatics 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® (soon to be 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™ for determining lung cancer of origin vs metastatic.
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 its
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 filings with the SEC, including
without limitation, the 2017 Annual Report on Form 10-K filed with
the SEC and the Company’s Quarterly Report on Form 10-Q for the
quarter ended March 31, 2018 . 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.
Contact
Investor RelationsJoe Green – Edison Group(646)
653-7030jgreen@ediosngroup.com
Andrew Gibson – Edison Group(646)
653-7026agibson@edisongroup.com
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