Oncocyte Reports Commercial Launch Progress; On Track to Sign 20 Transplant Centers by End of 2025 Transplant centers representing about 9% of German transplant volumes and about 2% of U.S. transplant volumes have signed

Reports Commercial Launch Progress; On Track to Sign 20 Transplant Centers by End of 2025

Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) - Oncocyte Corporation (Nasdaq: OCX) ("Oncocyte" or the "Company"),

a diagnostics technology company, today published the following letter to shareholders in conjunction with its third quarter results:

are pleased to report that we are making considerable progress on two fronts that help de-risk our path to meaningful revenue. First,

we are continuing to sign new research customers at well-respected hospitals and universities. In addition to the two customers mentioned

in our August update, we have now signed agreements with two leading transplant university hospitals in the U.S. and Germany,

as well as major research hospitals in Switzerland, Austria, and the U.K. Given the concentrated nature of the transplant market, we

believe each new customer represents a key step toward capturing an estimated $1 billion global total addressable market for our transplant

rejection testing technology.

our clinical kitted test product development remains on track, and we have already had productive dialogue with the U.S. Food and Drug

Administration (FDA), which we describe below.

international response to GraftAssure , which is our research-use-only assay that can detect early evidence of graft organ damage,

is exceeding our expectations. We attribute this success to our robust research partnerships in Europe, and to our team's scientific

leadership in researching the dd-cfDNA biomarker1 for over a decade. Our customers in Germany now represent about 9% of the

country's annual organ transplant volumes.2

we are making inroads toward capturing share in the much larger U.S. market. In August, we reported that our U.S. sales funnel represents

25% of transplant volumes. Three months later, we are pleased to report that hospitals representing about 2% of overall organ transplant

volumes3 have now signed up to use GraftAssure.

also received significant interest and engagement from the transplant lab community at the American Society for Histocompatibility &

Immunogenetics (ASHI) conference in Anaheim in October. This continuous positive reinforcement from the customer base gives us confidence

that we are on the right track.

cell-free DNA (dd-cfDNA). The proprietary intellectual property we acquired in 2021 was developed in Germany.

to Deutsche Stiftung Organtransplantation (DSO) data, 2023 German organ transplant volumes were 3,586 and German hospitals using GraftAssure

performed 323 transplants that year, representing about 9% of 2023 German transplant volumes.

to Organ Procurement and Transplantation Network data, 2023 U.S. kidney, liver, heart and lung transplant volumes were 45,562

and U.S. hospitals using GraftAssure performed about 930 transplants that year, representing about 2% of 2023 U.S. transplant volumes.

is at a pivotal stage in commercializing our IP in organ transplant, primarily by making a kitted test that quantifies an established

biomarker, donor-derived cell-free DNA (dd-cfDNA), and uses a digital-PCR workflow that we believe offers distinct advantages over assays

run on Next-Generation Sequencing (NGS) technology. Our scientists have played a pivotal role over the past decade in developing the

science that established dd-cfDNA as a trusted biomarker4, and we are now commercializing a product by pursuing a market disruptive

approach. We aim to deliver proven, more affordable, faster tests that can be run at local labs.

we don't expect meaningful revenue in transplant rejection testing until we have reached the clinical in-vitro diagnostic (IVD5)

stage of our kitted product development, we believe that customers who are signing up for GraftAssure RUO are motivated by the eventual

opportunity to use our IVD kits to measure this biomarker in their own labs, capturing the benefit of a rapid response time and the ability

to generate revenue by running the test.

also can run our clinical-use assay, VitaGraft, at our clinical lab in Nashville. We received Medicare reimbursement on that test in

are on track to meet the commitment that we made to investors in August to have more than 20 transplant centers running GraftAssure tests

through the end of 2025. We estimate that each center represents a potential annual high-margin revenue stream of several hundred thousand

dollars to $2 million of clinical-use tests, depending on the size of the center.

staying science-driven and putting customers first, we are building solid relationships. Deploying our GraftAssure assay is a key part

of our land-and-expand strategy to drive commercial adoption of our tests.

are especially pleased to report on how quickly we are moving to capture market share. GraftAssure began shipping in June and in less

than five months, we are well into step two of our land-and-expand strategy. In fact, we have one customer in the U.S. and one prominent

university hospital in Europe that are progressing to stage three. A simple breakdown:

a program that identifies and establishes coverage and U.S. government reimbursement for

molecular diagnostic tests, cited our publications twice when it established the LCD (Local

Coverage Determination) for Medicare and Medicaid reimbursement coverage for cell free DNA

testing. Source: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=38671&ver=4

kitted version of our assay must be cleared by regulatory bodies in the U.S., Europe and elsewhere as an in-vitro diagnostic (IVD) to

be used in clinical decision making.

Drive market penetration with GraftAssure to build customer install base

Democratize testing through FDA-cleared VitaGraft+ kit

recap, our strategy is to land major transplant centers and research universities with our research-use-only (RUO) product. Doing

so establishes our technology and increases its potential utility by enabling researchers to explore and expand potential applications

we have achieved FDA clearance for our test kits to be used to make clinical decisions - that is, approved as an IVD - we

believe that these institutions will begin using our VitaGraft+ tests to manage their patients, while continuing to use our GraftAssure

test kit to perform research. Of note, our GraftAssure research product may not be used to support clinical treatment decisions.

are pleased with our strategic progress and our ability to move quickly to establish a customer base to support future revenue growth.

As a reminder of our journey to date: The first prototypes of GraftAssure were completed in December 2023, and by April 2024, we welcomed

Bio-Rad Laboratories as an investor and strategic partner, supporting GraftAssure's global launch. Under this partnership, Bio-Rad

and Oncocyte are co-marketing GraftAssure in the U.S. and Germany. Bio-Rad has exclusive distribution and commercial rights of the RUO

product outside the U.S. and Germany, with the exception of several major potential international customers where both companies have

mutually agreed to allow Oncocyte to take commercial lead.

assay runs on a digital PCR (polymerase chain reaction) instrument, which allows us to create

a simple workflow for the lab technician, delivering a result in four to eight hours, compared

with 30 hours in estimated time using NGS technology. Further, testing a single sample

is an affordable option, given that the batch size - in contrast to NGS - does

not alter the cost per result.

Marketing refers to Conformit Europ enne (French for "European Conformity"), under the European Union's

transplant market is highly concentrated with fewer than 100 academic and research centers in the U.S. that account for approximately

80% of transplant volumes8. Markets outside the U.S. are similarly concentrated within high-end academic institutions. Bio-Rad's

global infrastructure puts those centers well within reach, allowing for high-touch sales and service in those regions.

are pleased to report that our FDA pre-submission remains on track. Since our last quarterly update, we have cleared the first stage

gate in our clinical product development process and submitted a Q-Sub to the FDA.

Oncocyte has submitted its plan for an IVD version of the dd-cfDNA kitted test to the FDA, beginning the Q-submission process. We already

have begun to engage in productive dialogue with the FDA, and a meeting is scheduled for early December in connection with the submission.

The Q-sub is a formal pathway for companies to get written feedback on their development plan and is a critical step in gaining confidence

in the validation process that we expect to begin in early 2025.

a reminder, the IVD development process occurs in three phases, culminating in FDA submission. Since our August update, we have completed

Phase 1: Planning and Inputs. We are currently in Phase 2: Design and Outputs and will proceed with Phase 3: Verification and Validation

we also are thrilled to report that several hospitals have expressed interest in supporting the FDA submission process. Six hospitals

or clinics, all of which are in major cities (given the highly concentrated nature of the transplant market) have expressed interest

in participating in our clinical observational study. In addition, four institutions have expressed interest in participating in the

reproducibility study. We believe these sites represent potential future VitaGraft+ customers.

clinical director of one transplant center, who expressed interest in supporting our FDA submission, told us that his transplant center

would benefit from having access to a kitted product. Because Oncocyte's kitted test is run on a digital PCR instrument9,

our FDA-cleared tests will be designed to provide actionable information when the time to treat is critical. "In a for-cause setting,

send out testing doesn't do me any good," the clinical director said. "I cannot wait for two days."

estimates based on UNOS data (https://unos.org/about/national-organ-transplant-system/

PCR provides ultrasensitive nucleic acid detection and absolute quantification.

continue to advance the science of dd-cfDNA and demonstrate its clinical value.

August 11, Transplant International published a review that concluded that dd-cfDNA is a valuable, non-invasive biomarker that

enhances graft surveillance and personalized therapy for patients with antibody-mediated rejection (AMR), potentially improving outcomes

and reducing premature graft loss.

in August, we announced a case series that represented the second study showing VitaGraft Kidney as a measure of response to the

benefit of therapy on AMR, which is a leading cause of allograft failure. The case series study, involving two patients, underscored

the significant potential of using repeated VitaGraft Kidney measurements to monitor the efficacy of a targeted therapy drug, in this

daratumumab study represented the second publication this year that showed Oncocyte's ability to monitor therapeutic efficacy.