Oncocyte Announces Publication of the Validation of DetermaIO in Predicting Immune Therapy Response in Metastatic Bladder Cancer
August 24 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 announces the peer-reviewed publication
evaluating the performance of DetermaIO™ in metastatic urothelial
(bladder) cancer treated with the immune checkpoint inhibitor
(ICI), Tencentriq® (atezolizumab). The results were published in
the Journal of Translational Medicine [August 16, 2022].
The IMvigor210 clinical trial treated 429
patients with Tencentriq, and the ICI was approved under an
accelerated approval pathway. However, this approval was withdrawn
for those patients who had previously failed platinum therapy based
on a follow-up ICI therapeutic trial which failed to achieve
significance, even if stratified by the standard biomarker, PD-L1
IHC. The results of the newly published biomarker study showed that
DetermaIO identified 40% of the 348 patients available for
DetermaIO biomarker analysis as likely responders, and that they
had a median survival of 15.6 months compared to 8.8 months without
biomarker stratification. At two years, 41.5% of DetermaIO-positive
patients were alive versus 28.6% in the population as a whole.
“This peer-reviewed publication demonstrates our
approach to translating DetermaIO to a novel tissue type, including
validating its performance as a classifier on a new tissue type,
validating the existing algorithm and threshold as a TIME
classifier, and then validating DetermaIO as an ICI response
predictor on the precious clinical trial samples,” commented Dr.
Doug Ross, Chief Science Officer at Oncocyte. “This approach
demonstrated that DetermaIO outperformed previously published gene
expression signatures and additional conventional biomarkers, which
supports its superior clinical utility in bladder cancer and keeps
us on track for a CMS submission this fall.”
Highlights of the peer-reviewed publication include:
- Clinical Validation of DetermaIO as
a predictor of response to ICI Therapy in a large clinical trial
population of 348 metastatic bladder cancer patients, a tissue
where DetermaIO had not previously been tested.
- DetermaIO outperformed nineteen
other genomic signatures and additional existing biomarkers
originally selected for testing.
- Continued evidence supports the
thesis that DetermaIO has utility across multiple cancer
types.
- The potential for DetermaIO to help
inform the use of immune checkpoint inhibitor therapy for advanced
bladder cancer.
- Illustration of how DetermaIO
captures a broad portrait of the complex tumor immune
microenvironment useful for diagnostic and therapeutic
development.
“We have always maintained the strength of
DetermaIO is the fact that it looks at three key components of the
tumor immune microenvironment, a hot signature, and two cold
signatures, leading to DetermaIO’s successful validation as an ICI
response predictor across six tissue types to date,” said Rob
Seitz, Head of Immune Oncology and Bioinformatics at Oncocyte. “We
continue to be encouraged by the repeated success of DetermaIO
independent of tumor type or immune therapy tested.”
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. DetermaIO™ was developed and its performance
characteristics determined by Oncocyte.
Tencentriq® is a registered trademark of
Genentech, Inc.
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 of a CMS submission
this fall, 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: 415.202.5678 caroline.corner@westwicke.com
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