Interpace Biosciences, Inc. (Nasdaq: IDXG) today announced
acceptance of the first manuscript reporting the clinical
performance of the company’s ThyGeNEXT® and ThyraMIR® tests in the
Journal of the American Society of Cytopathology. The article,
entitled “Clinical performance of multiplatform mutation panel and
microRNA risk classifier in indeterminate thyroid nodules”, will be
published online in the coming weeks.
The peer-reviewed manuscript will be the first
to report the clinical performance of the combination of ThyGeNEXT®
and ThyraMIR® in predicting cancer-free survival of patients with
indeterminate thyroid nodules. ThyGeNEXT® is an expanded version of
the previous NGS-based mutation panel test, ThyGenX®, previously
offered by the company. The expanded version now includes
additional mutation markers, such as NTRK and ALK fusions that have
targeted therapies and TERT and the RET proto-oncogene that can be
predictive of aggressive disease.
In addition, the abstract has been accepted for
a poster presentation at the upcoming Endocrine Society (ENDO)
Annual Meeting being held in San Francisco, CA March 28-31st. The
poster, entitled “Clinical Performance Of Multiplatform Mutation
Panel MicroRNA Risk Classifier In Indeterminate Thyroid Nodules”
will be presented in session P56, “Tumor Biology: Diagnostics,
Therapies, Endocrine Neoplasias, and Hormone Dependent Tumors” on
Sunday, March 29th from 1:00-3:00 p.m.
A study published in 2019 reported the clinical
utility of combination ThyGenX® and ThyraMIR® testing,
demonstrating that combination test negative results were
associated with the same low rate (11%) of thyroid nodule surgical
resection as other tests that effectively rule-out the need for
surgery in indeterminate thyroid nodules. Furthermore, the study
reported that combination test positive results were associated
with high rates (84%) of surgical resection, supporting the
effective use of the combination test in also ruling-in the need
for surgery. Importantly, the authors also concluded that decisions
to surgically treat indeterminate thyroid nodules were
appropriately aligned with a patient’s risk of malignancy, based on
the outcomes of patients in the study who underwent ThyGenX® and
ThyraMIR® testing.
The new publication will report the clinical
performance of combination ThyGeNEXT® and ThyraMIR®, in the same
patients, with new mutation markers that are part of ThyGeNEXT®
highlighted and test results again compared to the clinical
outcomes of patients. Both studies were led by Dr. Woody Sistrunk
from Endocrinology Center, Jackson, MS.
According to Jack Stover, CEO of Interpace,
“This new clinical utility paper expands the evidence that combined
ThyGeNEXT® and ThyraMIR® testing appropriately identified patients
with a surgical need from those who should be managed in an
alternate manner. We are proud of this clinical report and
anticipate future publications that will enhance the data available
on the performance of our molecular tests.”
About ThyGeNEXT® and
ThyraMIR®
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 a leader in enabling
personalized medicine, offering specialized services along the
therapeutic value chain from early diagnosis and prognostic
planning to targeted therapeutic applications.
Interpace Diagnostics is a fully integrated
commercial and bioinformatics business unit that 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.
Interpace’s Biopharma provides pharmacogenomics
testing, genotyping, biorepository and other customized services to
the pharmaceutical and biotech industries. The Biopharma Business
also advances 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.
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
10Q. 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
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