Oncocyte Reports Strong Q1 with Progress Toward Commercialization of Transplant Test Kit and Expanded Pharma Services Revenue

The diagnostics technology company Oncocyte Corporation (Nasdaq: OCX) has kicked off 2025 with significant momentum as it advances toward commercialization of its first clinical molecular diagnostic test kit for transplant rejection, a market estimated at $1Bn. The company reported substantial progress in clinical development, operational execution, and financial performance in its first quarter results.

Key Highlights

Clinical Trial Milestone: Oncocyte completed the clinical trial design for its lead transplant test and secured Institutional Review Board (IRB) approval. Several top U.S. transplant centers which represent nearly 10% of the country's transplant volume, are expected to participate in the study. The trial is expected to fulfill the clinical evidence requirements for an FDA Class II de novo submission in 2026.

GraftAssure Platform Gains Traction: The company's research-use-only (RUO) version of its transplant test, GraftAssureIQ, is now being used by 10 leading transplant centers across the U.S., Europe, and Southeast Asia. The ease-of-use improvements and digital PCR-based workflow are drawing strong interest from researchers and may open new clinical applications, including microchimerism detection and enhanced post-transplant monitoring.

Rebranding Initiative: Reflecting its broader mission beyond oncology, Oncocyte will unveil a new corporate name later in 2025. The company's transplant product line has been rebranded under the GraftAssure umbrella and include: GraftAssureCore, a CLIA-certified lab-developed test (LDT), GraftAssureIQ, the RUO test kit and GraftAssureDx, an IVD clinical decision-making test kit pending FDA approval.

On the conference call CEO of Oncocyte Josh Riggs stated, "I feel good about how far weve come and where we are going. Not only are we successfully building a market for our transplant product, but also we are seeing increased interest from potential corporate partners who see the value in our technology in both transplant and oncology. This type of external validation supports our confidence that we are on the right path, making the right investments, and have the right people to build a valuable business."

Financial Summary

In the first quarter of 2025, Oncocyte reported $2.14M in revenue, all generated from pharma services at its Nashville laboratory. The company achieved a gross profit of $1.33M, with gross margins improving significantly to 62% from 40% in the previous quarter, driven by automation and workflow efficiencies. Operating expenses totaled $8.1M million, which included investments in product development and one-time administrative costs. The net loss for the quarter was $6.7M million, or $0.26 per share. Oncocyte ended the quarter with $32.7M in cash, cash equivalents, and restricted cash, supported by a $28.7M capital raise in February. Cash burn remained in line with expectations, with $5.9M used in operations and $307K in capital expenditures.

Oncology Pipeline and Scientific Momentum

While transplant diagnostics remain the near-term focus, Oncocyte continues to invest in its oncology pipeline. The NeoTRIP study, which used the company's DetermaIO assay, demonstrated that the test can predict which triple-negative breast cancer patients benefit from adding immunotherapy to standard chemotherapy. This precision capability positions DetermaIO to support future drug development and rescue therapies that have underperformed in broader patient populations.

Oncocyte expects to enroll the first patient in its transplant clinical trial in the coming weeks and will introduce its national principal investigator and key medical advisors. The company believes its digital PCR-based transplant test will be well-positioned as the preferred in-house solution at transplant centers, supporting a high-margin recurring revenue model.

About Oncocyte
Oncocyte is a pioneering diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes. Investors may visit https://investors.oncocyte.com/ for more information.

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