Oncocyte Begins Manufacturing Transplant Blood Test
June 27 2023 - 8:30AM
Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics
company, today announced that it has begun the manufacturing
process for the distributable version of its patented transplant
technology. A method of checking for signs of graft damage in
transplant recipients, the assay measures levels of donor derived
cell-free DNA (dd-cfDNA) in the blood. Early access for this RUO
kit is expected to open in late Q4 2023.
“We believe that our patented method of
assessing graft damage offers distinct benefits over competing and
more invasive approaches,” said Josh Riggs, Oncocyte’s CEO.
“Oncocyte is committed to being a partner for the transplant
community. Our test provides a simple, easy-to-use workflow, on
droplet digital PCR, so researchers can perform in-house dd-cfDNA
testing. We believe opening access to our technology supports
broader research than what is addressable with today’s centralized
testing. We look forward to updating investors on rapid
manufacturing progress as we move to commercialization.”
The test can typically be accomplished within
the same day, without the necessity of donor genotyping. Results
will be provided in both percentage and precise quantification of
dd-cfDNA.
About Oncocyte
Oncocyte is a precision diagnostics company. The
Company’s tests are designed to help provide clarity and confidence
to physicians and their patients. VitaGraft™ is a blood-based solid
organ transplantation monitoring test. DetermaIO™ is a gene
expression test that assesses the tumor microenvironment to predict
response to immunotherapies, and pipeline test DetermaCNI™ is a
blood-based monitoring tool for assessing therapeutic efficacy in
cancer patients.
VitaGraft™, DetermaIO™, and DetermaCNI™ 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, the expectation that Oncocyte technology will be
available for early access in late Q4, 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 ContactJesse Arno(949)
409-6770jarno@oncocyte.com
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