Interpace Diagnostics Announces Coverage of Molecular Thyroid Testing by Independence Blue Cross
Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) announced today
that its ThyGeNEXT™ and ThyraMIR® tests for thyroid cancer are now
covered by Independence Blue Cross (Independence), providing plan
benefits coverage for its members who meet established medical
criteria for the tests. Independence covers nearly 2.5 million
members in Philadelphia and Southeastern Pennsylvania. Interpace’s
testing is made available to its members by its strategic partner,
LabCorp (NYSE: LH), Independence’s primary lab services provider,
through LabCorp’s Dianon Pathology specialty laboratory.
Jack Stover, President and CEO of Interpace,
stated, “We are pleased that Independence has established a medical
policy and criteria for our molecular thyroid tests, and that these
Independence members and their physicians now have cost-effective
access to our services.”
Interpace Diagnostics’ tests for thyroid cancer
are specifically intended for patients whose initial thyroid
nodules biopsy is indeterminate, without a conclusive indication of
whether the nodule is malignant or benign. Launched in 2015,
ThyraMIR was the first microRNA gene expression classifier that
tests for benign and malignant thyroid nodules. MicroRNAs are
small, non-coding RNAs that bind to messenger RNA and regulate
expression of genes involved in human cancers, including every
known subtype of thyroid cancer. ThyraMIR measures the expression
of 10 microRNAs.
In early 2018, Interpace Diagnostics launched
ThyGeNEXT, providing an expanded panel that includes markers of
aggressiveness as well as other markers that provide physicians
with insights to assist them make more-informed treatment decisions
for patients suspected of having thyroid cancers. 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.
In combination with ThyGeNEXT, ThyraMIR can more
accurately identify indeterminate thyroid nodules as malignant or
benign compared to standard clinical practice. ThyraMIR reports a
qualitative positive or negative result based on the gene
expression levels. A positive result indicates a high probability
of malignancy whereas a negative result is highly associated with
being benign. Test results should always be interpreted with the
consideration of other clinical information and should not be
solely relied on for diagnosis. The combination of both tests can
help ordering physicians improve risk stratification and surgical
decision-making when standard cytopathology does not provide a
clear diagnosis for the presence of cancer.
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, in 70%-80% of
cases in which surgery is performed, the nodule is ultimately
determined to be benign. Molecular testing using ThyGeNEXT –
ThyraMIR has been shown to reduce the rate of unnecessary surgeries
in indeterminate cases.
The American Thyroid Association has reported
that approximately 20% of the 525,000 thyroid fine needle
aspiration (FNA) biopsies performed on an annual basis in the U.S.
are indeterminate for malignancy based on standard cytological
evaluation. Patients with those results thus are candidates for
ThyGeNEXT and ThyraMIR.
ThyGeNEXT and ThyraMIR are covered by Medicare and a growing
list of commercial insurers.
About Independence Blue Cross
Independence Blue Cross is the leading health
insurance organization in southeastern Pennsylvania. With our
affiliates, we serve nearly 8 million people nationwide. For
more than 80 years, we have been enhancing the health and
well-being of the people and communities we serve by delivering
innovative and competitively priced health care products and
services; pioneering new ways to reward doctors, hospitals, and
other health care professionals for coordinated, quality care; and
supporting programs and events that promote wellness. To learn
more, visit www.ibx.com. Connect with us on Facebook at
facebook.com/ibx and on Twitter at @ibx. Independence Blue Cross is
an independent licensee of the Blue Cross and Blue Shield
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; 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
Interpace Diagnostics’ (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.
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 2018 Annual Report
on Form 10-K filed with the SEC and the Company’s 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.
Interpace Diagnostics Contact
Investor RelationsJoe Green – Edison Group(646)