Interpace Diagnostics Group, Inc. (NASDAQ:IDXG) (“Interpace” or
“the Company”), a fully integrated commercial company that provides
clinically useful molecular diagnostic tests and pathology services
for improved patient diagnosis and management, announced today that
Oxford Health Plans will cover Interpace’s ThyraMIR® test for
indeterminate thyroid nodules effective August 1, 2017.
Oxford Health Plans, a UnitedHealthcare company, offers
health care benefits to employers and individuals primarily in New
York, New Jersey, and Connecticut making it one of the largest
health plans in the heavily populated tri-state Region.
Oxford's commercial insured products and services include
traditional health maintenance organizations, preferred and
exclusive provider organizations, point-of-service plans and
consumer-driven health plans. In addition, Oxford also offers
Medicare plans and third-party administration of employer-funded
benefits plans.
With the addition of Oxford’s members, ThyraMIR is now covered
for over 250 million lives nationwide, including through Medicare,
National, and Regional health plans. This follows the Company’s
recent announcement of its National contract with Aetna for its
ThyGenX® and ThyraMIR products along with the approval by Cigna of
ThyGenX.
The ThyGenX® - ThyraMIR® combination represents the only test in
the market that includes the rule-in properties of next-generation
sequencing of a 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 current performance,
approximately 90% of the Company’s ThyGenX 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 15,000 ThyraMIR tests
for nearly 400 physicians and hospitals 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, “Oxford’s determination to cover ThyraMIR follows a steady
stream of payers that have recognized the value that both of our
Thyroid products play in identifying the appropriate patients for
surgery.” “We are pleased that Oxford has joined the growing list
of health plans that cover ThyraMIR and their members in New
York, New Jersey, and Connecticut will now have access to its
benefits.”
About Thyroid Nodules, ThyGenX 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.
ThyGenX and ThyraMIR are covered by both Medicare and Commercial
insurers.
About Interpace Diagnostics Group,
Inc.
Interpace Diagnostics 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 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. 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, our ability to adequately finance the 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 the Company’s periodic filings with the Securities and
Exchange Commission (SEC), including without limitation, the Annual
Report on Form 10-K filed with the SEC on March 31, 2017 and the
amendment on Form 10-K/A filed on April 28, 2017, the Company’s
Quarterly Report on Form 10-Q for the quarter ended March 31, 2017
filed with the SEC on May 12, 2017, and the Company’s Quarterly
Report on Form 10-Q for the quarter ended June 30, 2017 filed with
the SEC on August 10, 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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