Oncocyte Corp., (Nasdaq: OCX), a diagnostics technology company,
today announced additional favorable data regarding its lead assay
VitaGraft™, which was published in the journal, Nephrology Dialysis
Transplantation.
VitaGraft Kidney™ quantifies the amount of DNA fragments in
transplant patients’ blood that originate from the donor organ, a
key biomarker for assessing graft health. This process is commonly
referred to as donor-derived cell-free DNA (dd-cfDNA) testing and
is widely used in clinical practice today. In this latest study,
Oncocyte’s proprietary diagnostic dd-cfDNA test using digital PCR
was able to diagnose antibody-mediated rejection (AMR) in kidney
transplant recipients nearly a year ahead of standard
protocols1.
“We are excited to see our dd-cfDNA technology demonstrate
strong predictive value for AMR, supporting clinicians in
identifying AMR in patients sooner, thereby enhancing the
opportunity for better outcomes,” said Oncocyte Chief Science
Officer Dr. Ekkehard Schuetz. “The trial’s results further validate
dd-cfDNA as a critical biomarker that can bridge diagnostic gaps
for transplant patients.”
For further context, de-novo donor specific antibody (dnDSA) is
a routine biomarker used in kidney transplant management. The
appearance of dnDSA in a patient -- that is, the patient is found
to be dnDSA-positive (dnDSA+) -- signals an increased risk of AMR.
This latest study shows that compared to standard of care,
VitaGraft Kidney can significantly reduce the time to diagnosis of
AMR in dnDSA+ patients. It is also the first randomized
interventional study to validate any dd-cfDNA technology as a
rule-in test for biopsy in a high-risk population.
Catching AMR early, when kidney graft loss can be minimized, is
becoming increasingly important as physicians explore the use of
drugs, including the anti-CD38 drugs felzartamab and daratumumab,
to manage rejection. Monitoring with VitaGraft in this high-risk
patient population could support early intervention with these new
therapeutic options.
Once patients are on therapy, monitoring for therapeutic
efficacy is also important to manage potential unwanted side
effects. Publications using VitaGraft to monitor for efficacy for
both aforementioned drugs can be found in the New England Journal
of Medicine and Transplant International. In addition, earlier this
year, Oncocyte signed an agreement with a European biotechnology
company to be the provider of dd-cfDNA testing for a Phase II
clinical trial for a separate therapeutic in AMR.
Oncocyte expects to submit for claims expansion to its payor,
MolDX2, to support the use of VitaGraft for these high-risk
patients in the clinic. If granted, it would expand the use case
beyond the current for-cause claim, opening significant new revenue
opportunities.
In sum, this clinical trial provides compelling evidence for
dd-cfDNA monitoring as a tool for enhancing early intervention and
improving outcomes for patients at increased risk of transplant
rejection. Oncocyte scientists and inventors of the technology, Dr.
Schuetz, Julia Beck and Kirsten Bornemann-Kolatzki, co-authored the
study, which was initiated by researchers at Charité –
Universitätsmedizin Berlin under the leadership of Prof. Klemens
Budde. The study was published in Nephrology Dialysis
Transplantation: Oxford Academic and may be found by accessing this
link.
Additional study details: Highlighting potential for
improved patient outcomes, as well as implications for broader
clinical applications and future therapies
The interventional randomized trial, conducted between June 2021
and July 2023, involved 40 kidney transplant recipients with dnDSA,
assessing longitudinal dd-cfDNA monitoring as a guiding tool for
diagnostic biopsy compared to standard clinical practices.
Oncocyte’s proprietary dd-cfDNA technology was able to detect the
onset of AMR significantly earlier in patients by guiding the
indication for biopsy (median time from inclusion to diagnosis: 2.8
months) compared to the control group using standard of care (14.5
months). As noted above, this early intervention could offer a
valuable advantage in transplant care by enabling prompt treatment
before irreversible damage occurs.
"This study underscores the impact of dd-cfDNA as a critical
biomarker for early AMR detection, providing healthcare teams with
timely data enabling them to initiate treatments sooner," said Dr.
Aylin Akifova, first author from Charité.
This study also suggests that dd-cfDNA monitoring could also be
instrumental in identifying subclinical AMR—a silent condition
that, if undiagnosed, can lead to significant graft damage.
Additionally, the findings come at a crucial time, as mentioned
above, as promising new treatments, including CD38-targeted
therapies, are showing unprecedented efficacy in treating AMR.
Early diagnosis with dd-cfDNA could provide the earliest window for
intervention, offering an advantage for patients suffering from
AMR, a disease with historically very limited treatment
options.
“We congratulate Charité’s research teams on these compelling
findings, which further underscore our mission to empower
clinicians with tools for precision diagnostics while also
democratizing access to novel molecular diagnostic testing to
improve patient outcomes,” said Josh Riggs, CEO of Oncocyte. “We
look forward to expanding the clinical applications of dd-cfDNA
technology and supporting transplant communities worldwide with our
innovative diagnostic solutions.”
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 solid organ
transplantation monitoring test. GraftAssure™ is a research use
only (RUO) blood-based solid organ transplantation monitoring test.
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 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 will submit for claims expansion to MolDX to support
the use of VitaGraft for high-risk patients in the clinic, which
may expand the use case and open significant new revenue
opportunities, the company’s anticipated expansion of clinical
applications of dd-cfDNA technology, the company’s goal to support
transplant communities worldwide with its innovative diagnostic
solutions, 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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