Interpace Biosciences, Inc. (NASDAQ: IDXG) announced today that a
peer-reviewed manuscript describing results from a seminal clinical
validation study of the combination of ThyGeNEXT® and ThyraMIR® has
been accepted for publication in the highly respected journal,
Diagnostic Cytopathology. The study, led by Dr. Mark Lupo from the
Thyroid and Endocrine Center of Florida, reported on the ability of
the combination of ThyGeNEXT®/ThyraMIR® tests to successfully
stratify nearly 200 indeterminate thyroid nodules for risk of
malignancy. Sites participating in this multicentered study
included Cedars-Sinai Medical Center, Jackson Thyroid &
Endocrine Clinic, University of Michigan, Massachusetts General
Hospital/Harvard Medical School, and the University of Arkansas for
Medical Sciences. According to Jack Stover, President and CEO of
Interpace, “We’re excited that this important study will soon be
published in such a prominent peer reviewed journal and will be
further highlighted at the ASC Annual Meeting in November.” He
continued “We look forward to sharing these results with the
physician and payer communities shortly.”
About ThyGeNEXT® and
ThyraMIR®
ThyGeNEXT® is Interpace’s most recent next
generation sequencing test that was expanded from its original
version (ThyGenX®) to include markers that have targeted therapies
and those that can identify aggressive forms of thyroid 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, as well as
Medullary Thyroid Carcinoma. 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 ThyGeNEXT® and
ThyraMIR® are covered by Medicare and Commercial insurers, with
more than 280 million members covered.
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.
About Interpace Biosciences
Interpace Biosciences is an emerging leader in
enabling personalized medicine, offering specialized services along
the therapeutic value chain from early diagnosis and prognostic
planning to targeted therapeutic applications.
Clinical services, through Interpace
Diagnostics, provides clinically useful molecular diagnostic tests,
bioinformatics and pathology services for evaluating risk of cancer
by leveraging the latest technology in personalized medicine for
improved patient diagnosis and management. Interpace 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; 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® that differentiates lung cancer of
primary vs. metastatic origin. In addition, BarreGEN® for Barrett’s
Esophagus, is currently in a clinical evaluation program whereby we
gather information from physicians using BarreGEN® to assist us in
positioning the product for full launch, partnering and potentially
supporting reimbursement with payers.
Pharma services, through Interpace Pharma
Solutions, provides pharmacogenomics testing, genotyping,
biorepository and other customized services to the pharmaceutical
and biotech industries. Pharma services also advance personalized
medicine by partnering with pharmaceutical, academic, and
technology leaders to effectively integrate pharmacogenomics into
their drug development and clinical trial programs with the goals
of delivering safer, more effective drugs to market more quickly,
and improving patient care.
For more information, please visit Interpace Biosciences’
website at www.interpace.com.
About ASC
The American Society of Cytopathology (ASC),
founded in 1951, is a 3,000 member distinguished national
professional society of physicians, cytotechnologists and scientist
who are dedicated to the cytologic method of diagnostic pathology.
The ASC’s diverse membership includes representatives from other
countries who share a vision of education, research and continuous
improvement in the standards and quality of patient care. The ASC
is a unique society that provides a forum where physicians and
cytotechnologists can interact and network with each other on both
a personal and professional level.
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, including
the adverse impact of the Coronavirus (COVID-19) pandemic, our
history of operating losses and the limited revenue generated by
our clinical and pharma services customers, our dependence on sales
and reimbursements from our clinical services, our reliance on
third parties to process and transmit claims to payers for our
clinical services, and any delay, data loss, or other disruption in
processing or transmitting such claims could have an adverse effect
on our revenue and financial condition, our revenue recognition
being based in part on our estimates for future collections which
estimates may prove to be incorrect, that we will be able to meet
our revenue projections and that there is no guarantee that we will
be successful in completing development or realize any revenue or
benefit from our efforts to launch a new product line of antibody
testing of the COVID-19 virus. 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 filed
on April 22, 2020, Current Reports on Form 8-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 RelationsEdison Group Joseph
Green (646) 653-7030 jgreen@edisongroup.com
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