Oncocyte Corporation Stock Price, News & Analysis

Oncocyte Corp. (Nasdaq: OCX) is a diagnostics technology company in the in-vitro diagnostic substance manufacturing sector. The company focuses on molecular diagnostic testing designed to improve clinical decision-making in organ transplantation and oncology. Oncocyte describes its mission as democratizing access to novel molecular diagnostic testing to improve patient outcomes, with an emphasis on bringing advanced tests closer to patients through hospital and transplant center laboratories.

According to multiple company communications, Oncocyte is developing and commercializing blood-based assays that quantify donor-derived cell-free DNA (dd-cfDNA), a molecular biomarker used to monitor solid organ transplant health and detect signs of rejection. The company is building a kitted transplant rejection monitoring test that can be run in local hospital labs, and it also offers a dd-cfDNA assay from its CLIA-certified laboratory in Nashville, Tennessee. Oncocyte states that it is pursuing regulatory authorization of its transplant test kit through a Class II de novo pathway with the U.S. Food and Drug Administration (FDA), aiming to offer an in-vitro diagnostic (IVD) product that transplant centers can use in clinical decision-making.

Oncocyte’s transplant product portfolio has been organized under the GraftAssure brand for dd-cfDNA tests. The company reports that GraftAssureCore is its lab-developed test (LDT) run at its CLIA-certified Nashville lab and reimbursed by the Centers for Medicare & Medicaid Services (CMS). GraftAssureIQ is described as a research-use-only (RUO) test kit used by transplant centers and research hospitals, while GraftAssureDx is the planned IVD test kit intended for clinical use following FDA authorization. Oncocyte notes that it has rebranded its VitaGraft Kidney lab-developed assay under the GraftAssureCore name and is transitioning its prior GraftAssure RUO kit branding to GraftAssureIQ.

The company highlights that its transplant rejection assay uses a digital PCR (polymerase chain reaction) workflow. Oncocyte reports that this workflow runs on a Bio-Rad digital PCR instrument and is designed to be fast and straightforward for laboratory staff, with minimal hands-on time and a limited number of pipetting steps. In its shareholder communications, Oncocyte contrasts its digital PCR-based approach with assays that use next-generation sequencing (NGS), emphasizing attributes such as rapid turnaround time, simplified workflow, and sample economics that do not depend heavily on batch size. The company positions this approach as supportive of decentralized, in-lab testing at transplant centers.

Oncocyte has reported that transplant centers and research institutions in the United States, Europe, and Southeast Asia are using its GraftAssure research-use-only kits to explore applications of dd-cfDNA in transplant biology. The company cites use of its assay to study topics such as microchimerism and long-term graft health, including published data in the journal Transplantation Direct. In that publication, researchers used Oncocyte’s proprietary assay in kidney transplant recipients and described associations between dd-cfDNA levels, Banff scores, and histopathological lesions, supporting the assay’s long-term clinical validity and potential use in high-risk patient monitoring.

In addition to transplant diagnostics, Oncocyte maintains an oncology-focused pipeline. The company describes DetermaIO as a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies, and DetermaCNI as a blood-based monitoring tool for tracking therapeutic efficacy in cancer patients. Oncocyte has discussed the use of DetermaIO in the NeoTRIP study in triple negative breast cancer, where the assay was used to help identify which patients might benefit from adding a specific immunotherapy to chemotherapy in the neoadjuvant setting. The company presents these oncology assays as part of a broader effort to support precision medicine and pharmaceutical development.

Oncocyte also reports revenue from pharma services performed at its clinical laboratory in Nashville. In its shareholder letters, the company notes that processing samples on behalf of corporate customers provides revenue that helps offset costs while it advances its transplant and oncology product opportunities. The Nashville lab is described as a CLIA-certified facility that can run the company’s clinical-use transplant assay and support external research and pharma services projects.

The company has stated that it estimates a large addressable market for transplant rejection testing, referencing an estimated global total addressable market of about $1 billion annually. Oncocyte’s strategy communications describe a “land and expand” approach: initially placing research-use-only kits at leading transplant centers and research universities, then expanding into clinical use once its kitted assay receives regulatory authorization as an IVD. The company emphasizes that transplant centers are interested in in-house testing and that its technology is designed with transplant center labs in mind.

Oncocyte has also highlighted a strategic relationship with Bio-Rad Laboratories, which the company identifies as a key strategic partner and shareholder. According to Oncocyte, Bio-Rad has invested in the company multiple times and pledged financial support for the upcoming clinical trial and commercialization efforts related to the transplant assay program. Oncocyte has reported that equity financings, including a registered direct offering and concurrent private placement, are expected to fund the development of its FDA IVD transplant assay program through regulatory clearance and commercial launch.

The company has indicated that it plans to rename itself to better reflect a product pipeline that spans both organ transplant and oncology diagnostics, noting that its original name emphasized oncology. In SEC filings, the registrant is identified as Insight Molecular Diagnostics Inc., and the company continues to file periodic and current reports, hold annual meetings of shareholders, and seek shareholder approval for matters such as director elections, auditor ratification, executive compensation, and equity incentive plan amendments.

Business focus and operating model

Oncocyte’s communications describe a business focus centered on developing, validating, and commercializing molecular diagnostic tests and associated kits. The company develops proprietary assays, conducts clinical and scientific studies in collaboration with transplant centers and research institutions, and seeks regulatory and reimbursement pathways for its tests. It operates a clinical laboratory in Nashville that supports both clinical testing and pharma services, and it develops kitted versions of its assays intended for deployment in hospital and transplant center laboratories.

The company’s transplant strategy emphasizes decentralized testing, where local labs at transplant centers can run dd-cfDNA assays using Oncocyte’s kits. Oncocyte notes that it has achieved CLIA validation and CMS reimbursement for the lab-developed version of its transplant assay and is working toward FDA authorization of the kitted IVD version. It has described its planned clinical trial for the transplant kit as a prospective, observational, single-arm, multicenter study designed to validate dd-cfDNA thresholds and evaluate performance metrics such as sensitivity, specificity, positive predictive value, and negative predictive value compared with existing methods.

In oncology, Oncocyte positions its assays as tools for predicting response to immunotherapies and monitoring treatment efficacy. The company references published data and collaborations with pharmaceutical partners and clinical investigators to explore how its biomarkers can be used in drug development and patient management. These activities align with its stated mission to democratize access to molecular diagnostics and support precision medicine.

Regulatory and reimbursement context

Oncocyte reports that it is pursuing FDA authorization for its transplant test kit via the de novo pathway for Class II medical devices. The company describes interactions with the FDA through Q-Submission (Q-Sub) meetings, where it receives feedback on study design and regulatory expectations. It has stated that its upcoming clinical trial is the only one required to obtain FDA authorization for its first transplant test kit, and that it already has CLIA validation and Medicare reimbursement for the lab-developed version of the assay.

The company also notes that the Molecular Diagnostics (MolDX) program, managed by a Medicare contractor, has expanded coverage for its transplant assay in specific high-risk patient populations. Oncocyte links this coverage expansion to published clinical data showing that monitoring with its assay can reduce time to rejection diagnosis in patients with newly developed donor-specific antibodies. The company views these reimbursement developments as supportive of the market potential for its kitted transplant product.

Capital markets and corporate governance

Oncocyte’s shares trade on Nasdaq under the symbol OCX. The company has disclosed equity financings, including a registered direct offering and a concurrent private placement, led by its largest shareholders. It has indicated that proceeds from these offerings, together with existing cash, are expected to fund the transplant assay program through FDA authorization. In SEC filings, the company, identified as Insight Molecular Diagnostics Inc., reports on matters such as financial results, shareholder meeting outcomes, and amendments to its equity incentive plans.

At its 2025 annual meeting of shareholders, the company reported that shareholders voted on the election of directors, ratification of its independent registered public accounting firm, an advisory vote on executive compensation, and an amendment to increase the number of shares authorized under its equity incentive plan. Voting results disclosed in the filing show that each director nominee was elected and that the other proposals received shareholder approval.

FAQs

• What does Oncocyte Corp. do?
  Oncocyte Corp. is a diagnostics technology company that develops and commercializes molecular diagnostic tests. Its primary focus is on blood-based assays for organ transplant rejection monitoring and oncology, including dd-cfDNA tests for transplant centers and gene expression and blood-based monitoring tools for cancer care.
• What is the main focus of Oncocyte’s transplant program?
  Oncocyte’s transplant program centers on a dd-cfDNA-based assay for solid organ transplantation monitoring. The company is developing a kitted transplant rejection monitoring test that can be run in local hospital labs and is pursuing FDA authorization through a Class II de novo pathway, while also operating a CLIA-validated, reimbursed lab-developed version of the test.
• What are GraftAssureCore, GraftAssureIQ, and GraftAssureDx?
  Oncocyte describes GraftAssureCore as its lab-developed dd-cfDNA test run at its CLIA-certified Nashville lab and reimbursed by CMS. GraftAssureIQ is the research-use-only test kit used by transplant centers and research institutions, and GraftAssureDx is the planned in-vitro diagnostic test kit intended for clinical decision-making following regulatory authorization.
• How does Oncocyte’s digital PCR workflow relate to its transplant assay?
  The company reports that its transplant rejection assay uses a digital PCR workflow on a Bio-Rad digital PCR instrument. Oncocyte emphasizes that this workflow is designed to be fast and simple for lab technicians, with minimal hands-on steps and a turnaround time that supports decentralized testing at transplant centers.
• Where does Oncocyte conduct its clinical and pharma services testing?
  Oncocyte states that it operates a CLIA-certified clinical laboratory in Nashville, Tennessee. This lab runs the company’s clinical-use transplant assay and provides pharma services by processing samples for corporate customers.
• What oncology tests does Oncocyte offer?
  Oncocyte identifies DetermaIO as a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies, and DetermaCNI as a blood-based monitoring tool for tracking therapeutic efficacy in cancer patients. The company has discussed the use of DetermaIO in the NeoTRIP study in triple negative breast cancer.
• How is Oncocyte approaching regulatory authorization for its transplant kit?
  The company reports that it is pursuing FDA authorization for its transplant test kit via the de novo pathway for Class II medical devices. It has completed clinical trial design, obtained central institutional review board approval, and is preparing a multicenter clinical trial intended to provide the clinical evidence needed for its planned FDA submission.
• What is the relationship between Oncocyte and Bio-Rad Laboratories?
  Oncocyte describes Bio-Rad Laboratories as a strategic partner and significant shareholder. Bio-Rad has invested in Oncocyte multiple times and has pledged financial support for the upcoming clinical trial and commercialization of the transplant assay program.
• Has Oncocyte indicated any plans to change its corporate name?
  In a shareholder letter, Oncocyte stated that it plans to unveil a new company name to better reflect its broader focus on both organ transplant and oncology diagnostics, noting that its original name emphasized oncology. SEC filings identify the registrant as Insight Molecular Diagnostics Inc.
• Is Oncocyte still an active public company?
  Based on recent SEC filings and news releases, the company continues to trade on Nasdaq under the symbol OCX, files current reports such as Forms 8-K, holds annual meetings of shareholders, and reports financial results and corporate developments.