Interpace Diagnostics Announces Publication of Important New Data on Thyroid Test Performance
May 01 2019 - 6:55AM
Data from Registry Study Confirms the Value of
ThyGenX® and ThyraMIR® in a Clinical Setting
Interpace Diagnostics Group, Inc. (NASDAQ: IDXG) (“Interpace” or
“the Company”) announced today that data from its thyroid registry
has been published in the peer reviewed publication Diagnostic
Cytopathology in a paper called “Clinical impact of testing for
mutation and microRNA’s in thyroid nodules.” The new data from over
300 samples was compiled from a two-year, real-world, retrospective
study and highlighted the clinical utility of Interpace’s ThyGenX®
thyroid oncogene panel in combination with ThyraMIR®, its micro-RNA
classifier. Following the review and acceptance, the study is now
available on the journal’s website
https://onlinelibrary.wiley.com/doi/full/10.1002/dc.24190 and at
https://thygenext-thyramir.com/.
In summary, the study shows results from
ThyGenX® and ThyraMIR® combination testing demonstrated the ability
to help avoid unnecessary surgical resections as well as help
target nodules for which surgery is the accurate approach.
Importantly, the study also showed that surgical decisions made
with our combination thyroid tests were appropriately aligned with
risk of malignancy over multiple years of clinical follow-up, which
is consistent with a combination test that effectively rules-in and
rules-out higher risk of malignancy. We believe these results
further confirm the value that ThyGenX® and ThyraMIR® combination
testing brings when confronted with an indeterminate cytology
finding.
Importantly, Interpace conducted a bridge study
using both ThyGenX® and its newest mutation panel, ThyGeNEXT®, that
demonstrated 100% concordance between the tests. Further, the
Company is now engaged in a separate multi-site clinical validation
study of ThyGeNEXT® in combination with ThyraMIR®. Results from
this additional study are expected to be released in the second
half of 2019.
Dr. J. Woody Sistrunk, MD, the lead author on
the paper said, “This new clinical data confirms the value of
complementary use of ThyGenX® and ThyraMIR® testing in the
management of my patients with indeterminate thyroid nodules by
cytology. This combination testing approach has greatly reduced the
number of unnecessary surgeries for patients in real-world
clinical practice."
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. ThyraMIR® 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; 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. 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. Known and
unknown risks, uncertainties and other factors include, but are not
limited to, the fact that success in clinical studies may not be
replicated in later studies or demonstrate the clinical utility of
the test, the market's acceptance of its molecular diagnostic tests
and the Company’s ability to retain and secure reimbursement among
other things. 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
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