Interpace Biosciences Announces New Draft LCD and Reimbursement for Its Proprietary Thyroid Assay, ThyGeNEXT®
December 17 2019 - 6:55AM
Interpace Biosciences, Inc. (Nasdaq: IDXG) today announced
that its Medicare Administrative Contractor (MAC) has issued a new
draft local coverage determination (LCD) for the Company’s
ThyGeNEXT® test, representing an increase of approximately $2,400
per assay over previous reimbursement coverage. This increase in
reimbursement rates reflects the expansion of the ThyGeNEXT® panel
to aid in identifying the appropriate patients for surgery. In
2018, Interpace processed approximately 12,500 ThyGeNEXT® tests.
Prior to the new LCD code (81455) becoming
effective, it was subject to a public comment period, which ended
December 15, 2019, and is now subject to an analysis and review
period by MAC’s Medical Directors. Final approval is expected
during the first quarter of 2020. ThyGeNEXT® has been covered by an
existing LCD since it was launched in mid-2018 and its predecessor,
ThyGenX®, has been covered since 2014.
Jack Stover, President & CEO of Interpace,
said, “I am very pleased with the draft local coverage announcement
and look forward to the final determination, which when approved
will demonstrate the quality of our expanded assay, and most
importantly supports continued reimbursement for patients and their
families potentially affected by Thyroid cancer.” 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 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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