Interpace Biosciences Terminates Rights Offering Announces Change in CMS Medicare Reimbursement of its Thyroid Tests
January 28 2022 - 7:35PM
Interpace Biosciences, Inc. (OTCQX: IDXG) (“Interpace” or the
“Company”) a leader in enabling personalized medicine, announced
today that it was terminating its previously announced rights
offering and the mutual termination of the standby purchase
agreement with 3K Limited Partnership.
Interpace also announced that it just became
aware that the Centers for Medicare & Medicaid Services (CMS)
issued a new billing policy whereby CMS will no longer reimburse
for the use of the Company’s ThyGeNEXT® and ThyraMIR® tests when
billed together by the same provider/supplier for the same
beneficiary on the same date of service. The Company is currently
evaluating the new policy’s potential impact on the Company while
simultaneously preparing an appeal. The CMS change does not in any
way impact the efficacy of the diagnostic information provided to
clinicians.
Tom Burnell, Interpace’s President and CEO
stated, “We are disappointed to terminate the rights offering due
to the likely adverse impact of the change in CMS’s policy but we
are determined to seek alternative sources of financing to support
the Company’s business. We will continue to evaluate the impact of
the change in the CMS policy and potential changes on the Company’s
operations and will keep our stockholders informed.”
Peter Kamin, an affiliate of 3K Limited
Partnership, added “In light of the change in CMS’s policy, we are
disappointed that we are unable to proceed with the rights offering
and the standby purchase agreement. Nevertheless, we look forward
to working together with Interpace to assess the change in CMS’s
policy and to develop a new plan to satisfy the Company’s financial
and operational goals.”
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 five
commercialized molecular tests and one test in a clinical
evaluation program (CEP): PancraGEN® for the diagnosis and
prognosis of pancreatic cancer from pancreatic cysts; PanDNA, a
“molecular only” version of PancraGEN® that provides physicians a
snapshot of a limited number of factors; 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
versus metastatic origin. In addition, BarreGEN®, a molecular based
assay that helps resolve the risk of progression of Barrett’s
Esophagus to esophageal cancer, is currently in a clinical
evaluation program (CEP) whereby we gather information from
physicians using BarreGEN® to assist us in gathering clinical
evidence relative to the safety and performance of the test and
also providing data that will potentially support payer
reimbursement.
Pharma services, through Interpace Pharma
Solutions, provides pharmacogenomics testing, genotyping,
biorepository and other customized services to the pharmaceutical
and biotech industries. Pharma services 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,
while also 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 statements, including,
but not limited to, the adverse impact on the Company of the change
in CMS’s reimbursement policy regarding the use of ThyGeNEXT® and
ThyraMIR® tests when used together, the adverse impact of the
COVID-19 pandemic on the Company’s operations and revenues, the
substantial doubt about the Company’s ability to continue as a
going concern, the possibility that the Company’s estimates of
future revenue, cash flows and adjusted EBITDA may prove to be
materially inaccurate, the Company’s history of operating losses,
the Company’s ability to adequately finance its business and seek
alternative sources of financing, the Company’s ability to repay
borrowings with Comerica Bank and BroadOak, the Company’s
dependence on sales and reimbursements from its clinical services,
the Company’s ability to retain or secure reimbursement including
its reliance on third parties to process and transmit claims to
payers and the adverse impact of any delay, data loss, or other
disruption in processing or transmitting such claims, and the
Company’s revenue recognition being based in part on estimates for
future collections which estimates may prove to be incorrect.
Additionally, all forward-looking statements are subject to the
“Risk Factors” detailed from time to time in the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2020, as
amended, Current Reports on Form 8-K and Quarterly Reports on Form
10-Q filed with the Securities and Exchange Commission. 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 RelationsInterpace Biosciences, Inc.(855)
776-6419Info@Interpace.com
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