Oncocyte Announces Unanimous Recommendation from the Advisory Panel for Clinical Diagnostic Laboratory Tests on DetermaRx to CMS
September 07 2022 - 8:00AM
Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics
company with the mission to improve patient outcomes by providing
personalized insights that inform critical decisions throughout the
patient care journey today, announced that the Advisory Panel for
clinical diagnostic laboratory tests (CDLT) has unanimously
recommended that starting January 2023, the Company’s DetermaRx™
test be cross-walked to CPT code 81522, currently priced at $3,873.
Medicare (CMS) will consider this recommendation and is expected to
post its preliminary decision in mid-September for public comments
and issue a final determination in mid-November.
Separately, the Company announced that Palmetto
GBA, a Medicare administrative contractor for the Molecular
Diagnostics Services program (MolDX), has conveyed the validity of
a Local Coverage Determination (LCD) reconsideration request for
broader coverage for DetermaRx to include risk-stratification (in
conjunction with TNM staging) to assess the risk of recurrence for
the early-stage NSCLC patient to determine the best course of
action for patient management.
“On the heels of the VA Contract announcement,
we are very excited to share that we have received the confirmation
of MolDX’s decision to recommend expanded coverage for DetermaRx
pending the required public opinion period. Gaining this expansion
as a risk of recurrence test allows physicians the choice of
therapy for their high-risk patients, especially important given
the interest in using immunotherapy earlier in the disease cycle,”
said Ron Andrews, Chief Executive Officer of Oncocyte. “We were
also encouraged by the recommendation by CMS’s advisory panel to
move DetermaRx into a high-value category and await the posting of
the final decision. DetermaRx continues to gain momentum as a
powerful indicator of recurrence risk in early-stage NSCLC and to
date has impacted the lives of well over 1100 lung cancer
patients.”
About OncocyteOncocyte is a precision
diagnostics company with a mission to improve patient outcomes by
providing personalized insights that inform critical decisions
throughout the patient care journey.
Through its proprietary tests and pharmaceutical
services business, the Company aims to help save lives by
accelerating the diagnosis of cancer and advancing cancer care. The
Company’s tests are designed to help provide clarity and confidence
to physicians and their patients at every stage. DetermaRx™
identifies early-stage lung cancer patients who are at high risk
for cancer recurrence and who may benefit from adjuvant
chemotherapy. DetermaIO™ is a gene expression test that assesses
the tumor microenvironment to predict response to immunotherapies.
The Company’s pipeline of tests in development also includes
DetermaTx™, which will assess mutational status of a tumor,
DetermaCNI™, a blood-based monitoring test, DetermaMx™, a long-term
recurrence monitoring test, and VitaGraft™, a blood-based solid
organ transplantation monitoring test. In addition, Oncocyte’s
pharmaceutical services provide companies that are developing new
cancer treatments a full suite of molecular testing services to
support the drug development process.
DetermaRx™, DetermaIO™, DetermaTx™, DetermaCNI™,
DetermaMx™ and VitaGraft™ are trademarks of Oncocyte
Corporation.
Forward-Looking StatementsAny
statements that are not historical fact (including, but not limited
to statements that contain words such as “will,” “believes,”
“plans,” “anticipates,” “expects,” “estimates,” “may,” and similar
expressions) are forward-looking statements. These statements
include those pertaining to the expectation that CMS will post its
preliminary decisions regarding DetermaRx in mid-September for
public comments and issue a final determination in mid-November,
and potential expanded LCD coverage for DetermaRx, and other
statements about the future expectations, beliefs, goals, plans, or
prospects expressed by management. Forward-looking statements
involve risks and uncertainties, including, without limitation, the
potential impact of COVID-19 on Oncocyte or its subsidiaries’
financial and operational results, risks inherent in the
development and/or commercialization of diagnostic tests or
products, uncertainty in the results of clinical trials or
regulatory approvals, the capacity of Oncocyte’s third-party
supplied blood sample analytic system to provide consistent and
precise analytic results on a commercial scale, potential
interruptions to supply chains, the need and ability to obtain
future capital, maintenance of intellectual property rights in all
applicable jurisdictions, obligations to third parties with respect
to licensed or acquired technology and products, the need to obtain
third party reimbursement for patients’ use of any diagnostic tests
Oncocyte or its subsidiaries commercialize in applicable
jurisdictions, and risks inherent in strategic transactions such as
the potential failure to realize anticipated benefits, legal,
regulatory or political changes in the applicable jurisdictions,
accounting and quality controls, potential greater than estimated
allocations of resources to develop and commercialize technologies,
or potential failure to maintain any laboratory accreditation or
certification. Actual results may differ materially from the
results anticipated in these forward-looking statements and
accordingly such statements should be evaluated together with the
many uncertainties that affect the business of Oncocyte,
particularly those mentioned in the “Risk Factors” and other
cautionary statements found in Oncocyte’s Securities and Exchange
Commission (SEC) filings, which are available from the SEC’s
website. You are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date on
which they were made. Oncocyte undertakes no obligation to update
such statements to reflect events that occur or circumstances that
exist after the date on which they were made, except as required by
law.
Investor & Media ContactCaroline CornerICR WestwickeTel:
415.202.5678caroline.corner@westwicke.com
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