OncoCyte Corp (OCX) News & EventsOCXNews & EventsOncoCyte Corp

OncoCyte changes name to Insight Molecular Diagnostics

Insight Molecular Diagnostics announced its renaming and the relocation of its principal executive office from Irvine, California, to Nashville, Tennessee. The Company's common stock, listed on the Nasdaq Capital Market, will begin trading under the new stock symbol "IMDX," effective before the market opens on Wednesday, June 18, 2025. The new name more accurately reflects the Company's expanded strategic direction and diversified product portfolio. Although oncology remains a key area of innovation, the new name better reflects its expanded strategic direction and diversified portfolio, including a focus on transplant medicine. The Company remains committed to its goal of delivering a clinically available molecular diagnostic kit to expand testing access for kidney transplant patients, which it anticipates will unlock value in the estimated $1B addressable market for transplant rejection testing. So far in 2025, iMDx believes it has made disciplined and focused progress toward this goal, executing the critical steps required to transition from product development to commercialization. To support these efforts, iMDx is relocating its principal executive office from Irvine, California to Nashville, Tennessee - home to the Company's CLIA-certified lab and a growing hub for healthcare innovation. The move reflects a strategic alignment of operations and proximity to both core infrastructure and industry talent. The Company also expects to maintain its laboratory and research and development center in Gottingen, Germany. The new name leverages iMDx's existing rights to the name Insight Genetics, which it acquired in 2020. In addition, the Company's CLIA-certified and CAP-accredited lab in Nashville launched as "Insight Molecular Labs," in 2013 and maintains that name today. The Company's new iMDx logo features DNA banding patterns on the "i," as well as a centered MD - for medical doctor, reflecting iMDx's healthcare provider-centric philosophy. Further, "Dx" is a common industry abbreviation for both diagnostics and diagnosis. As part of the rebranding initiative, iMDx is also retiring the VitaGraft name and unifying its transplant diagnostics under the GraftAssure brand. The updated nomenclature will better align with each product's regulatory classification and intended use: GraftAssureCore - The Company's lab-developed test, currently reimbursed by CMS and performed at its CLIA-certified laboratory in Nashville. GraftAssureIQ - An RUO kit intended for non-clinical applications and clearly labeled as such. GraftAssureDx - The in vitro diagnostic kit currently in development for use in clinical decision-making, which the Company intends to submit for FDA authorization.

OncoCyte reports Medicare boosts reimbursement for GraftAssureCore

On May 19, Oncocyte provided "a positive update on pricing" for its next-generation lab-developed test, GraftAssureCore. The Centers for Medicare & Medicaid Services has improved its reimbursement rate to $2,753 per result. This represents an increase from the prior structure using an earlier version of the assay, which paid $2,222 for first-time testing of a patient and $1,029 for subsequent tests, noted the company. GraftAssureCore is Oncocyte's lab-developed test, which is run at the company's CLIA-certified Nashville lab. "Over the past two years Oncocyte has made significant investments in improving the scalability and manufacturability of our workflow to support our kitted test program. Last fall, we transferred these improvements into our CLIA lab and submitted to MolDX3 for repricing. We are very pleased with the result," said CEO Josh Riggs.

OncoCyte provides update on progress toward initiating clinical trial

Oncocyte provided an update on its substantial progress toward initiating its clinical trial, which is a major step required to obtain regulatory authorization to deliver an organ transplant rejection monitoring test kit to the market. Oncocyte has completed its clinical trial design and has received approval from a large central institutional review board, which is a committee that reviews and oversees the safety and ethics of clinical trials across multiple hospital sites. Within the coming weeks, Oncocyte expects to welcome three of the top 10 transplant centers in the United States as clinical trial participants. The U.S. transplant centers engaged in supporting Oncocyte's clinical trial collectively represent nearly 10% of U.S. transplanted organ volume. The company values the clinical expertise and diverse patient populations that these leading transplant centers contribute to the trial. Oncocyte estimates that transplant rejection testing generates about $500M in revenue per year in the U.S., largely dominated by a few central labs. U.S. regulatory authorization of Oncocyte's kitted test would enable transplant centers to perform this testing locally in their own labs, thus generating revenue for themselves and increasing the sustainability of local care for the community. Globally, Oncocyte estimates that the total addressable market for transplant rejection testing exceeds $1B annually. In the coming weeks, the company plans to announce the identity of its National Principal Investigator and host a conference call to introduce this key opinion leader to the medical and investor communities. Importantly, the upcoming clinical trial is the only one required to obtain FDA authorization for Oncocyte to bring its first test kit to market. For clarity, Oncocyte is 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. The company has already achieved CLIA validation and reimbursement of the lab-developed version of the test with Centers for Medicare & Medicaid Services. Additionally, Oncocyte also announced that in the coming weeks it expects to complete its second and final Q-Submission meeting, which is a formal process for requesting feedback from the FDA before applying for product authorization. Oncocyte's first Q-Sub meeting in December and subsequent conversations have remained productive, featuring collaborative dialogue with FDA reviewers.