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, today announced that
Premera Blue Cross, the largest Regional health plan based in
Mountlake Terrace, Washington, has agreed to cover Interpace’s
ThyraMIR® test for all of its more than 2 million members located
primarily in Washington, Oregon, and Alaska. Premera Blue
Cross has a network of more than 38,000 physicians, hospitals,
laboratories, and other healthcare providers across the Northwest.
Interpace’s ThyraMIR assay is now covered for thyroid nodules
deemed indeterminate by standard cytopathological analysis.
With the addition of Premera’s members, ThyraMIR is now covered for
over 250 million patients nationwide, including through Medicare,
National, and Regional health plans. The Company also recently
announced coverage of ThyraMIR by United Healthcare and Aetna.
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, “The agreement by Premera Blue Cross to cover ThyraMIR is
further evidence of the clinical utility as well as clinical
validity of our thyroid assays. We are pleased that Premera has
joined the growing list of health plans that cover ThyraMIR and
that their 2 million members 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.
Both 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 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 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 Registration Statement on Form S-1 (333-218140)
initially filed with the SEC on May 22, 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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