Oncocyte Reports Q1 2025 Results and Business Progress Q1 2025 pharma services revenue of $2.1 million, at 62% gross margin Three of the top 10 U.S. transplant centers expected to participate in clinical trial Ten global

Reports Q1 2025 Results and Business Progress

Calif., May 12, 2025 (GLOBE NEWSWIRE) - Oncocyte Corp. (Nasdaq: OCX), a diagnostics technology company, today published the following

letter to shareholders in conjunction with its first quarter results:

off to a fast and intensely focused start in 2025. Just two months ago, we shared our strategic outlook - and since then,

we've remained heads down, executing. Our top priority is unchanged: bringing our first clinical molecular diagnostic test kit

to market so that we may begin capturing value in the estimated $1 billion total addressable market for transplant rejection testing.

The first quarter was defined by disciplined progress, as our team performed the essential work required to advance from development

to commercialization.

parallel, our Nashville lab generated $2.1 million in pharma services revenue in Q1 2025, exceeding expectations. We supported a major

corporate customer by processing samples on their behalf. This revenue helps to offset costs as we continue to make progress with our

core transplant and oncology product opportunities. That benefit was larger this quarter because of process improvements that raised

our gross margins from 40% in Q4 to 62% in Q1.

the sections that follow, we provide updates on our clinical trial, general business momentum, renaming and rebranding plans, and our

first-quarter 2025 financial results.

has completed the clinical trial design for its clinical molecular diagnostic testing kit and has received approval from a large central

institutional review board (IRB). Central IRBs are committees that review and oversee the safety and ethics of clinical trials across

multiple hospital sites. Obtaining IRB approvals is a key step in setting up a clinical trial.

the coming weeks, Oncocyte expects to welcome at least three of the top 10 transplant centers in the United States as clinical trial

participants. These three institutions are the largest of several transplant hospitals that are actively engaged in supporting Oncocyte's

clinical trial, and collectively represent nearly 10% of U.S. transplanted organ volume. We value the clinical expertise and diverse

patient populations that these leading transplant centers will contribute to the trial.

look forward to announcing the first patient being enrolled as well as introducing the study's National Principal Investigator

(NPI) and key opinion leaders to the medical and investor communities.

expect that the strong support we see from leading transplant centers will serve us well once our lead transplant test receives FDA authorization

and reaches the commercialization stage. Our research shows that transplant centers prefer in-house testing rather than send-out, central

lab testing and that physicians are likely to continue managing the treatment of patients using the transplant centers' preferred

testing platform. As a result, we believe that becoming the in-house testing technology of choice at transplant centers should support

a sustainable, long-term, high-margin recurring revenue business model.

we expect the upcoming clinical trial to satisfy clinical evidence requirements for our planned FDA submission. In 2026, we expect clearance

of that submission, which will support U.S. marketing authorization of our first clinical use transplant test kit. For clarity, we are

pursuing a Class II de novo pathway - a regulatory route for lower-risk medical devices. Class II medical devices carry

lower risk than Class III devices, which are typically life-supporting technologies. We already have achieved CLIA (Clinical Laboratory

Improvement Amendments) validation and reimbursement of the lab-developed version of our test with Centers for Medicare & Medicaid

Services (CMS). But for commercialization of the kitted version of our assay to begin, it must be cleared by regulatory bodies

in the U.S., Europe and elsewhere as an in-vitro diagnostic (IVD) test to be used in clinical decision making.

remain pleased with the quality of the engagement we've had with the FDA and are looking forward to our final pre-submission (Q-Sub)

meeting in the coming weeks.

leading transplant centers are now using our GraftAssure research-use-only (RUO) kits: We remain on track to meet our August 2024

commitment to have at least 20 transplant centers adopting our GraftAssure RUO kits by the end of 2025. As a reminder, the first part

of our strategy is to land major transplant centers and research universities with our research-use-only product. Doing so establishes

our technology and increases its potential utility by enabling researchers to explore potential applications of donor derived cell free

DNA (dd-cfDNA.) Then, once we have achieved FDA clearance for our test kits to be used to make clinical decisions - that is, cleared

for commercialization as an IVD - we believe that these institutions will expand their use of our tests to manage their

patient populations. (Importantly, research-use-only products may not be used to support clinical treatment decisions.) Once our test

receives IVD authorization for clinical use from the FDA, we estimate that each transplant center that uses our test kit will have the

potential to generate high-margin annual revenue in the range of several hundred thousand dollars up to $2 million, depending on that

center's testing volume.

launching the RUO version of GraftAssure in summer 2024, interest from transplant centers has exceeded our expectations. Based on feedback

from early pilot sites, we've now finalized key ease-of-use improvements to the research kit. The test now features minimal hands-on

time, requiring only a few simple pipetting steps. First commercial orders are expected later this year.

10 centers currently using GraftAssure RUO kits include three in the U.S., six in Europe, and one in Southeast Asia-all leading,

high-quality research hospitals.

discoveries point to pipeline expansion: Hospital labs are using GraftAssure to advance their research - and, in the process,

are uncovering valuable new applications. For example, researchers are using GraftAssure to detect microchimerism (the presence of a

small number of cells in an individual that originate from a genetically different individual). Microchimerism has become increasingly

important in transplant biology, where its detection can provide insights into graft health, early signs of rejection, and long-term

use of digital PCR is a key differentiator and supports evolving research: Our assay appears to be demonstrating the utility of digital

PCR (polymerase chain reaction) in the field - and we are receiving positive feedback that suggests our PCR-based workflow may

be a strategic differentiator. Researchers are exploring our assay's potential to improve post-transplant monitoring and potentially

identify complications earlier than traditional methods. These emerging use cases for our test underscore GraftAssure's versatility

and precision, leveraging digital PCR to support broader innovation in the field.

recap the significance of our test's use of digital PCR: We utilize a digital PCR workflow that we believe offers distinct advantages

over assays run on Next-Generation Sequencing (NGS) technology. Digital PCR is fast, simple to use, quantitative, and has better sample

economics at low volumes. Our transplant rejection assay runs on a Bio-Rad digital PCR instrument, which allows us to create a simple

workflow for the lab technician. In addition, our PCR-based workflow delivers a result in four to eight hours, compared with an estimated

30 hours using NGS technology. Furthermore, testing a single sample is an affordable option given that the batch size - in

contrast to NGS - does not meaningfully alter the cost per result. We look forward to continuing to demonstrate digital PCR's

advantages in sample economics, with the flexibility to scale up or down at local labs.

to advance transplant science: A study recently published in Transplantation Direct that used our assay to identify graft

rejection in patients up to 13 years post-transplant has been received positively in the field, as well as in strategic discussions with

new potential corporate partners. This study delivered a robust data set involving 131 patients with 151 kidney biopsies enrolled over

four years at Charit University in Berlin. We believe that the results of this study support market expansion for testing of

the high-risk patient population and deliver new insights that advance our understanding of the biology of organ rejection.

our oncology pipeline: In addition to our solid momentum in transplant, we also are making selective investments in our longer-term

product pipeline. For example, our NeoTRIP study has accelerated both the strategic and scientific direction of our DetermaIO assay,

bringing pharmaceutical partners and clinical collaborators to the table to explore how the biomarker can be used to advance patient

care and therapeutic development.

recap the significance of the NeoTRIP study, which we announced in 2021 and published in 2024, our 27-gene expression assay,

DetermaIO, was used to help identify which patients might benefit from adding atezolizumab-a monoclonal antibody immunotherapy-to

a standard chemotherapy regimen for Stage II/III triple negative breast cancer in the neoadjuvant (pre-surgery) setting. The results

showed that DetermaIO was able to statistically predict which patients would benefit from the addition of immunotherapy. In terms of

pathologic complete response (meaning the tumor had completely disappeared as a result of neoadjuvant therapy prior to surgical resection)

only DetermaIO-positive patients showed a benefit by adding atezolizumab to the chemotherapy, compared with patients who were treated

with chemotherapy alone. Remarkably, no such benefit was reported for DetermaIO-negative patients.

developments point to a growing opportunity for our assay to support drug rescue - reviving therapies that failed to meet their

primary endpoint. Our biomarker can be used to enrich for likely patient responders increasing the chance of success for the drug in

and product renaming:

year, we'll be unveiling a new company name that better reflects our strategic direction. While Oncocyte spoke to our origins,

it no longer captures the full scope of our product pipeline. Our focus now includes both organ transplant and oncology. So, the "onco"

prefix-derived from the Greek word for tumor-has become too narrow for a company with a broader mission to democratize access

to molecular diagnostic testing. Though we remain committed to advancing oncology diagnostics, both our near-term focus and our long-term

reach have considerably broadened.

new name is designed to reflect the depth of our pipeline and the insights we aim to bring to advancing molecular diagnostics. We are

excited to unveil our new name to investors, who should be pleased to note that we expect this to be an efficient and relatively low-cost

endeavor. As we keep our cash burn low, we plan to let the quality of our science speak for itself.

also are rebranding our transplant diagnostic product portfolio. Going forward, we will set aside the VitaGraft name and GraftAssure

will serve as the umbrella brand for our dd-cfDNA test portfolio.