Interpace Diagnostics Announces New York State Approval
April 23 2019 - 6:55AM
State of New York Approves Commercialization of
ThyraMIR® Now in Three Specimens
Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) announced today
that it has received approval to launch ThyraMIR® diagnostic
testing on formalin-fixed, paraffin-embedded (“FFPE”) tissue
samples from thyroid nodules from the State of New York. ThyraMIR®
is now the only molecular test approved to be used on indeterminate
thyroid nodule samples presented via fine needle aspirates in RNA
Retain®, cytology slides, and FFPE fixation in the State of New
York. In combination with the previous New York State approval of
the Company’s next-generation thyroid product, ThyGeNEXTÒ,
physicians and patients now have increased access to Interpace’s
thyroid product suite across a wide spectrum of specimen types
providing a single point of access for molecular testing.
The ThyGeNEXT®/ThyraMIR® combination represents
the only test on the market that includes the rule-in properties of
next-generation sequencing of the patient’s DNA and RNA along with
the rule-out capabilities of a micro-RNA classifier to provide
physicians with clinically actionable test results
Jack Stover, President and CEO of Interpace
Diagnostics, stated, “We are pleased to have obtained approval from
the State of New York allowing us to utilize our thyroid tests
across a full spectrum of specimen types. With this increased
convenience factor, we can now provide our thyroid molecular
testing services to an even broader customer base.”
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. ThyraMIRÒ 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
Interpace 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 improved patient diagnosis and management.
Interpace’s mission is to provide personalized medicine
through molecular diagnostics, innovation and data to advance
patient care based on rigorous science. 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; ThyGeNEXTÒ
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 50,000 patients who have been tested using the
Company’s current products, including over 25,000 molecular tests
for thyroid nodules. Interpace has been designated by the 2018
edition of CIO Applications as one of the top 10 companies for
providing bioinformatics solutions. 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.
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 Relations - Edison
GroupJoseph Green(646) 653-7030jgreen@edisongroup.com
Interpace Biosciences (NASDAQ:IDXG)
Historical Stock Chart
From Apr 2024 to May 2024
Interpace Biosciences (NASDAQ:IDXG)
Historical Stock Chart
From May 2023 to May 2024