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Oncocyte Reports Successful 2024; Sets Stage for 2025 Catalysts Q4 2024 revenue of $1.5 million in pharma services; full year revenue of $1.9 million GraftAssure RUO assay launched July 2024 Signed strategic partner and

Key Takeaway: Oncocyte Corp. reported a successful 2024, achieving $1.5 million in Q4 revenue and $1.9 million for the full year in pharma services. The company launched the GraftAssure RUO assay in July 2024 and secured a strategic partnership with Bio-Rad Laboratories, enhancing its funding and commercialization efforts. Key advancements include FDA engagement for a clinical trial process, which aims to establish a regulated organ transplant rejection monitoring test kit. With expanding Medicare reimbursement and growing interest from leading transplant centers, Oncocyte is poised for further growth in the transplant diagnostics market.

Market Sentiment Analysis

POSITIVE FACTORS

  • Successful launch of GraftAssure RUO assay with growing adoption.
  • Strategic partnership established with Bio-Rad Laboratories for support.
  • Significant expansion in Medicare claims for monitoring assays.
  • Positive feedback from FDA pre-submission meeting, signaling regulatory progress.

Full Press Release Details

Reports Successful 2024; Sets Stage for 2025 Catalysts
Q4 2024 revenue of $1.5 million in pharma services; full year revenue of $1.9 million
GraftAssure RUO assay launched July 2024
Signed strategic partner and investor, Bio-Rad Laboratories
Fully funded clinical kitted product development with $50+ million in equity raises
Advanced science in transplant; achieved Medicare claims expansion
Calif., March 24, 2025 (GLOBE NEWSWIRE) - Oncocyte Corp. (Nasdaq: OCX), a diagnostics technology company, today published the following
letter to shareholders in conjunction with its fourth quarter results:
Our dynamic team is making swift progress toward delivering a regulated organ transplant rejection monitoring test kit to
the market next year. To be clear, this test kit is the assay that we expect can generate future material and self-sustaining revenue
within a few years. In 2024, we began to drive commercial awareness of our tests and capture market share in the estimated $1 billion
total addressable transplant rejection testing market.
our November 2024 update, our confidence in the transplant opportunity has grown in line with the enthusiasm we see among leading transplant
centers to participate in our clinical trial as part of our FDA submission. With the clinical trial agreement process already underway,
we are eager to name these globally recognized and well-respected institutions in the coming weeks.
expect that our clinical trial will be conducted at several leading U.S. transplant centers and a leading transplant research institution
in Europe, reinforcing the global credibility of our approach. We are sincerely impressed by the demand that we see among transplant
centers to become part of our clinical trial. Their strong interest has exceeded our expectations, underscoring the need for localized
and reliable testing solutions.
recap the significance of this trial, in January 2023, when we first decided to commercialize our transplant intellectual property (IP)
by designing a kitted test, we essentially planted a flag that said we would put our assay through the approval processes of the FDA
and its EU equivalent. This decision was significant because in the U.S., we estimate that most complex molecular diagnostics tests are
run without FDA authorization and are instead performed in siloed, centralized labs. Moreover, these North American lab tests
are not easily accessible to hospitals in the rest of the world. Regulatory authorization is a key step toward achieving our mission
to democratize access to these important tests. With regulatory authorization, we anticipate selling test kits to hospital labs, thereby
empowering hospitals to run the tests themselves to expediently deliver actionable results.
is our belief that if we do the hard work of designing a lab test in kitted form, and achieving regulatory authorization, we will not
only democratize access to these tests - thus bringing care closer to the patient and helping hospitals to operate more sustainably
- but also create a rapidly growing, high-margin, recurring business model.
December 5, 2024, we had our first meeting with the FDA. We were pleased with the collaborative nature of the discussion and our reviewers'
feedback. As we continue to develop our kitted product technology alongside our clinical trial, we are targeting submission to the FDA
by the end of this year, followed by FDA authorization in 2026.
our research-use-only version of the transplant assay, which has been in the field since July, has generated invaluable feedback
from leading transplant center labs, allowing us to refine the product for an enhanced user experience. These collaborations continue
to build momentum, increasing awareness within the transplant community and reinforcing the potential for clinical use of digital PCR
technology for transplant rejection testing.
is at a pivotal stage in commercializing what we expect to be an industry-transforming organ transplant rejection monitoring test. We
aim to deliver proven, more affordable, faster tests that can be run at local labs.
we are developing a kitted test that quantifies a molecular biomarker known as donor-derived cell-free DNA (dd-cfDNA). Our scientists
in Germany and the U.S. have played a critical role over the past decade in developing the science that helped establish dd-cfDNA as
a trusted biomarker1 of transplant rejection, and we are now commercializing that technology using a market disruptive approach.
goal is to enable transplant centers to use our kits to capture the potential patient benefit of a rapid response time and the business
benefit of generating laboratory revenue by running the test. In addition to designing a laboratory test in kitted form, our assay uses
a digital-PCR workflow that we believe offers distinct advantages over assays run on Next-Generation Sequencing (NGS) technology.
expect meaningful revenue in transplant rejection testing after we have reached the clinical in-vitro diagnostic (IVD2) stage
of our kitted product development. In the meantime, we believe that customers who are now adopting GraftAssure test kits for research
use are motivated in part by the eventual opportunity to use our IVD kits to measure this biomarker in their own labs.
also can run our clinical-use assay, VitaGraftTM, at our clinical lab in Nashville, Tenn. We received Medicare reimbursement
for the test run at our lab in August 2023.
back: 2024 Highlights
launched the research version of our kitted transplant assay in July 2024: Bringing research centers online with our GraftAssure
RUO assay was a key part of our land-and-expand strategy to drive commercial adoption of our tests. This also was an important step toward
capturing market share in an estimated $1 billion global total addressable market for transplant rejection testing. In 2H 2024, we signed
leading transplant centers in the U.S. and Germany, as well as the UK, Switzerland, Austria, and Southeast Asia. Within six months of
launch, transplant centers representing about 9% of German transplant volumes and about 2% of U.S. transplant volumes had signed on to
use GraftAssure RUO in its early launch phase.
claims expansion for transplant rejection monitoring: In January 2025, we announced that Medicare coverage for our assay expanded
following a study showing that monitoring with Oncocyte's assay significantly reduces time to rejection diagnosis in patients with
newly developed donor-specific antibodies (DSA). The Molecular Diagnostics program (MolDX) confirmed the use of VitaGraft Kidney to monitor
patients with newly developed donor-specific antibodies (dnDSA+) for antibody-mediated rejection (AMR). This achievement followed the
publication of a groundbreaking study demonstrating VitaGraft Kidney's ability to detect AMR in dnDSA+ patients up to 11
months earlier than the current standard of care. Early detection of transplant rejection is growing in significance as novel therapeutic
treatments show promising early results in treating antibody mediated rejection. Indeed, leveraging our clinical assay in our laboratories
to support data generation is a key lever in our strategy that increases the market potential for our kitted product.
a key strategic partner and investor: In April 2024, we welcomed Bio-Rad Laboratories (NYSE: BIO) as a strategic investor and partner.
Bio-Rad subsequently invested in Oncocyte two additional times. Bio-Rad now is a top shareholder, holding approximately 9.66% of Oncocyte's
outstanding shares as of today. In addition to its equity investments, Bio-Rad has pledged to provide valuable financial support for
the upcoming clinical trial and further commercialization assistance, underscoring the depth of its strategic partnership with Oncocyte.
the science of transplant and oncology, with favorable data published in:
The New England Journal of Medicine
Transplant International
Clinical Cancer Research
Nephrology Dialysis Transplantation
Acta Neuropathologica Communications
a productive first meeting with the FDA: As noted above, one of our most significant milestones was our pre-submission meeting with
the FDA on December 5, 2024. At that meeting, we received valuable feedback regarding their expectations for marketing authorization
of our kitted clinical tests. The FDA clarified that we may proceed using the de novo pathway rather than a 510(k) submission. We view
this as a meaningful accomplishment - it establishes a new device category for our kitted test and reinforces the uniqueness and
potentially large clinical value of our technology. We are in continuous dialogue with the FDA with the next meeting scheduled in the
funded our clinical assay development and streamlined our capital structure: From January 2023 until March 2025, we raised $57 million
in equity from new and existing investors. This includes the $29 million from our February 2025 registered direct offering and concurring
private placement, in which our five largest shareholders, including Bio-Rad, led the funding round. We expect the offering proceeds
to fully fund the development of our transplant assay program through FDA authorization. Also in 2024, we redeemed all remaining shares
of our Series A Redeemable Convertible Preferred Stock - positioning us favorably with a streamlined capital structure ahead of
a growth inflection point.
our team: In June 2024, in preparation for the next several years of sustained, rapid growth, we welcomed Andrea James as Chief Financial
Officer. She has a proven track record of guiding financial strategy through multiple phases of growth, raising and stewarding capital,
and building relationships with high quality institutional investors. In January 2025, we appointed Dr. Paul Billings as Consulting Chief
Medical Officer. Dr. Billings is a recognized pioneer in genomics and precision medicine with over 40 years of experience spanning academia,
government, and the biotechnology industry, including as Chief Medical Officer at Natera, Inc., during the commercialization phase of
its blood test for kidney transplant rejection as well as its cancer blood test that can identify minimal residual disease. He also has
been an advisor or a physician leader with Laboratory Corporation of America Holdings, Quest Diagnostics, Life Technologies Corp, Johnson
& Johnson, and Thermo Fisher Scientific, contributing to transformative advances in molecular medicine. Dr. Billings has substantial
experience in commercializing novel assays in precision medicine. He will provide key regulatory and reimbursement support and assist
with business development efforts and strategic partnerships.
believe that our market opportunity is promising, and that we must continue to focus and execute. As the market shifts away from centralized
testing, our easy-to-use technology positions us to potentially lead the transition to decentralized, in-lab diagnostics.
with favorable data expected later this year regarding our transplant assay, we anticipate further validation of our assay's performance,
which we believe will be instrumental in driving adoption and securing payer support.
three major goals this year:
the above immediate regulatory and product development objectives, we are preparing for a broader industry shift in transplant care.
By 2028, we expect localized, real-time monitoring to become the standard of care, and we believe that we are well-positioned to capture
an outsized share of this evolving and growing market.
enthusiasm we have seen from transplant centers, patient advocates, and industry partners reinforces our belief that we are building
something transformative. We remain confident that the next few years will define the future of transplant diagnostics and solidify our
leadership in this space.
Oncocyte Management Team
2024 Financial Overview

Frequently Asked Questions

What was Oncocyte's Q4 2024 revenue?

Oncocyte reported Q4 2024 revenue of $1.5 million in pharma services.

What is the GraftAssure RUO assay?

The GraftAssure RUO assay is a research-use-only transplant assay launched in July 2024.

Who is Oncocyte's strategic partner?

Oncocyte signed a strategic partnership with Bio-Rad Laboratories.

What major milestone did Oncocyte achieve with the FDA?

Oncocyte had a productive meeting with the FDA, establishing a new device category.

What does the VitaGraft test do?

VitaGraft tests monitor transplant rejection, with Medicare coverage expanded in January 2025.

Last updated: Mar 24, 2025