Oncocyte Completes Validation of TheraSure™ Transplant Monitor Test
May 05 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 it has completed
development of its proprietary TheraSure™ Transplant Monitoring
test for liver transplant patients. This announcement marks the
successful completion of technology transfer and Oncocyte’s
readiness to deploy TheraSure following the Company’s acquisition
of Chronix Biomedical.
“Today’s announcement marks the first product to
be launched clinically from our Chronix acquisition completed in
April 2021. The tech transfer of the proprietary blood based
technology used to develop TheraSure was an important undertaking
for our R&D team in Germany and our CLIA lab team in Nashville,
and I am extremely proud of the herculean effort put forth to meet
the aggressive timeline we set last year to put us in a position to
launch the liver indication in the first half of 2022,” said Ron
Andrews, President and CEO of Oncocyte. “Management believes that
the streamlined workflow developed by our two expert PCR
development teams paves the way for expedited validation of
TheraSure for kidney and heart transplants and prepares the Company
for the important work ahead to convert the lab workflow into a
kit.”
The TheraSure Transplant Monitor, a
donor-derived cell-free DNA (dd-cfDNA) test which has shown to
successfully achieve an early indication of rejection episodes in
organ transplant patients using a digital polymerase chain reaction
(dPCR) technique, may allow for timely post-transplant treatment
modification to prevent organ damage. Oncocyte’s patented test has
been validated in clinical cohorts that have been published in
kidney, liver and heart transplantation.
“The anticipated speed and accuracy of dPCR
testing, particularly the proprietary TheraSure Transplant Monitor
test, are important attributes of our technology. We are thrilled
to enable access of this test through our laboratory offering,
meeting a truly unmet need for liver transplant patients and their
physician care teams that is backed by peer-reviewed and published
data,” said Ekkehard Schutz, MD, PhD, FAACC, CTO and Head of Blood
Based Testing at Oncocyte. “Today, there is no other alternative
test for liver transplant patients, and I am proud of the lab
team’s efforts to develop a workflow that can meet the goal of same
day turnaround time of results once the blood sample is accessioned
into our lab. Based on the successful validation of our dPCR
workflow for TheraSure, we believe we can provide these results to
certain transplant labs within one or two days of receipt of the
blood sample to inform timely, critical medical decisions.”
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.
The Company, through its proprietary tests and pharmaceutical
services business, 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 post-diagnosis treatment.
DetermaRx™ identifies early-stage lung cancer patients who are at
high risk for cancer recurrence and who may benefit from adjuvant
chemotherapy. DetermaIO™, a gene expression test currently used as
a research-use only tool, 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, blood-based test DetermaCNI™, which
can monitor cancer patients for recurrence of disease, long-term
recurrence monitoring test DetermaMx™, and blood-based solid organ
transplantation monitoring test TheraSureTM. 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
TheraSure™ are trademarks of Oncocyte Corporation.
Forward-Looking Statements
Any 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, among other things,
TheraSure, such as the expectation of expedited validation of
TheraSure for kidney and heart transplants and of conversion of the
lab workflow into a kit, 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 ContactCaroline CornerICR
Westwicke415.202.5678Caroline.corner@westwicke.com
Media ContactMegan KernanICR Westwicke
Healthcare PRTel: 646.677.1870Megan.kernan@westwicke.com
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