The Federal Employee Health Benefit BCBS Program
Adds Approximately 5.3 Million Covered Lives
Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) announced today
that the Blue Cross Blue Shield (“BCBS”) Federal Employee Health
Benefit Program (“FEHBP”) has extended coverage of ThyGeNEXT™ and
ThyraMIR® to its 5.3 million covered lives including federal
employees, retirees and their families. The FEHBP relies on
consumer choices among competing private plans to determine costs,
premiums, benefits, and service and currently has a 66% federal
employee and retiree plan participation rate.
The ThyGeNEXT™/ ThyraMIR® combination represents the only test
on the market that includes rule-in and rule-out properties. The
rule-in characteristic utilizes next generation sequencing of the
patient’s DNA and RNA along with rule-out capabilities of micro-RNA
providing physicians with clinically actionable test results. Based
on current performance, over 90% of the Company’s ThyGeNEXT™ cases
are reflexed to ThyraMIR® for additional assessment. Interpace has
conducted over 25,000 tests for nearly 400 physicians and hospitals
nationwide following the initial mutational panel, ThyGenX®, launch
in 2014. Earlier this year, the Company launched its next
generation mutational panel, ThyGeNEXT™, which represents a more
comprehensive set of indicators to not only identify malignant or
benign nodules, but also ascertain aggressiveness and other
characteristics providing physicians with incremental insights to
assist in the 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 and molecular testing using
ThyGenX® / ThyraMIR® has been shown to reduce the rate of
unnecessary surgeries in indeterminate cases.
Jack Stover, President and CEO of Interpace, stated, “We are
pleased one of the largest national Blue Cross Blue Shield plans
now covers our molecular thyroid tests providing these federal
employees and their families with access to our thyroid assays.”
Mr. Stover continued, “This continues the trend among other Blue
Cross Blue Shield plans making our unique ThyGeNEXT™/ ThyraMIR®
combination tests available to their members.”
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
Diagnostics Group, Inc.
Interpace is a fully integrated commercial and
bioinformatics company 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. The Company currently 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.
BarreGEN® for Barrett's Esophagus, is currently being “soft
launched” with key opinion leaders as we continue to gather data on
this assay that will assist us in seeking favorable reimbursement
as well as important clinical information. Barrett's Esophagus is a
rapidly growing diagnosis that affects over three million people in
the US and over time can progress to esophageal cancer.
The Company’s data base includes data from over 45,000 patients
who have been tested using the Company’s current products,
including over 25,000 molecular tests for thyroid nodules.
Interpace has also been designated as one of the top 20 companies
for providing bioinformatics solutions according to CIO
Applications magazine, a publication that is known to offer
professionals a comprehensive collection of industry trends.
Interpace’s mission is to provide personalized medicine
through molecular diagnostics, innovation and data to advance
patient care based on rigorous science. 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. 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:
Investor RelationsJoe Green – Edison Group(646) 653 -
7030jgreen@edisongroup.com
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