Oncocyte Demonstrates Potential for Liquid Biopsy of Brain Tumors in New Study
2024年12月5日 - 6:15AM
Oncocyte Corp. (NASDAQ: OCX), a diagnostics technology company,
today announced the publication of favorable data regarding its
DetermaCNI™ assay.
In a paper recently published in the journal Acta
Neuropathologica Communications, DetermaCNI showed promise as a
liquid biopsy method for diagnosing and profiling central nervous
system tumors by measuring somatic copy number aberrations (SCNAs)
in cerebrospinal fluid.
For context, copy number instability (CNI) is a scientifically
well-known hallmark of cancer. DetermaCNI™ is a patented
approach to measuring CNI for the diagnosis and monitoring of
cancer. Nearly 300,000 patients in the U.S. each year face primary
brain tumors or brain metastasis1. The current standard of care for
the confirmation and classification of brain tumors often involves
high-risk, highly invasive biopsy of brain tissue. Thus, a liquid
biopsy method for diagnosing brain tumors could offer significant
benefits over currently available methods, representing a potential
$300 million U.S. market opportunity.
Among the study authors were Oncocyte Chief Science Officer Ekke
Schuetz and Senior R&D Director Julia Beck.
“This was a proof of principle study to assess whether copy
number instability could be measured in the cerebrospinal fluid of
patients with brain cancer. The findings suggest that a significant
number of the nearly 300,000 patients diagnosed with brain tumors
every year in the U.S. could benefit from DetermaCNI,” Dr. Schuetz
said. “We congratulate the research team in Frankfurt on the
publication of this study in an area of high unmet need.”
As noted in the paper, the gold standard for precise diagnostic
classification of brain tumors requires a biopsy, with risks
including limited sensitivity and failing to measure the diverse
potential regions of the tumor. SCNAs were observed in the
cerebrospinal fluid of ten out of the 12 patients with confirmed
central nervous system cancers. SCNAs were not observed in any of
the 11 patients with benign or unclear central nervous system
lesions. The detection of SCNAs is highly specific for
tumor-derived cell-free DNA (cfDNA).
Overall, this new study demonstrates DetermaCNI’s potential for
providing a molecularly informed diagnosis of central nervous
system cancers, mapping tumor heterogeneity, tracking tumor
evolution, and surveilling tumor patients through a liquid biopsy
of cerebrospinal fluid.
Oncocyte believes this study validates the future clinical
potential for DetermaCNI, as well as the direction of the company’s
research and development pipeline, which is designed to drive
sustained rapid growth over the next decade. Oncocyte’s mission is
to democratize access to molecular diagnostic testing to improve
patient outcomes. The company is investing in developing products
to serve the separate verticals of organ transplant testing and
oncology. Oncocyte is presently commercializing its transplant
product line, which includes the VitaGraft™ and GraftAssure™ tests.
It expects to commercialize its oncology assays over the next two
years.
_______________1 “Brain Metastases.” MD Anderson Cancer Center,
www.mdanderson.org/cancer-types/brain-metastases.html. And “Brain
Tumor Facts.” National Brain Tumor Society, 20 Feb. 2024,
braintumor.org/brain-tumors/about-brain-tumors/brain-tumor-facts/.
About OncocyteOncocyte is a
diagnostics technology company. The Company’s tests are designed to
help provide clarity and confidence to physicians and their
patients. VitaGraft™ is a clinical blood-based dd-cfDNA solid organ
transplantation monitoring test. GraftAssure™ is a research use
only (RUO) blood-based solid dd-cfDNA organ transplantation
monitoring test kit for decentralized use. DetermaIO™ is a gene
expression test that assesses the tumor microenvironment to predict
response to immunotherapies. DetermaCNI™ is a blood-based
monitoring tool for monitoring therapeutic efficacy in cancer
patients. For more information about Oncocyte, please
visit https://oncocyte.com/. For more information about our
products, please visit the following web pages:
VitaGraft Kidney™
- https://oncocyte.com/vitagraft-kidney/VitaGraft
Liver ™
- https://oncocyte.com/vitagraft-liver/GraftAssure™
- https://oncocyte.com/graftassure/DetermaIO™
-
https://oncocyte.com/determa-io/DetermaCNI™
- https://oncocyte.com/determa-cni/
VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™
are trademarks of Oncocyte Corporation.
CONTACT:Jeff RamsonPCG Advisory(646)
863-6893jramson@pcgadvisory.com
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, among other things, the belief that
the new study validates the future clinical potential for
DetermaCNI, as well as the direction of the company’s research and
development pipeline, the expectation that Oncocyte will
commercialize its oncology assays over the next two years, 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, 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.
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