PARSIPPANY, N.J., April 18, 2017 /PRNewswire/ -- Interpace
Diagnostics Group, Inc. (NASDAQ: IDXG) (the "Company"), a fully
integrated commercial company that provides clinically useful
molecular diagnostic tests and pathology services, today announced
that UnitedHealthcare, the largest health plan in the United States, has agreed to cover
Interpace's ThyraMIR® test used in assessing indeterminate thyroid
nodule fine needle aspirate (FNA) biopsies. The coverage is now in
effect and is subject to members' specific benefit plan design. The
UnitedHealthcare policy decision is consistent with the National
Comprehensive Cancer Network (NCCN) Thyroid Carcinoma Guidelines,
which recommend that clinicians consider the use of molecular
testing to identify patients with indeterminate cytopathology
results whose nodules are actually benign and can thus avoid
surgery. Interpace is not currently a contracted, in-network lab
provider with UnitedHealthcare. Interpace's ThyGenX® and ThyraMIR
assays are now covered for approximately 250 million patients
nationwide, including through Medicare, National, and Regional
health plans. Medicare approved coverage for ThyraMIR in
January 2016 (LCD L35396).
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 ThyraMIR on April 15,
2015 making it available to Endocrinologists and
Pathologists throughout the country. Since then, the Company has
conducted over 5,000 ThyraMir tests for nearly 400 physicians and
hospitals.
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 Interpace Diagnostics Group, Inc.
Interpace is a fully integrated commercial 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 evaluation of pancreatic cysts
and assessment of risk of concomitant or subsequent cancer;
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's mission is to
provide personalized medicine through molecular diagnostics and
innovation to advance patient care based on rigorous science. For
more information, please visit Interpace Diagnostics' website at
www.interpacediagnostics.com.
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. ThyGenX and ThyraMIR
are covered by both Medicare and Commercial insurers.
Forward Looking Information
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 debt 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 Annual Report on
Form 10-K filed with the SEC on March 31,
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, the Company undertakes no obligation to revise or
update publicly any forward-looking statements for any
reason.
CONTACTS:
Interpace Diagnostics
Investor Relations:
Paul Kuntz
Redchip
Paul@Redchip.com
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SOURCE Interpace Diagnostics Group, Inc.