OCX Overview

Company Rebranding and Relocation: Insight Molecular Diagnostics Inc. (iMDx), formerly Oncocyte Corporation, has rebranded to better reflect its focus on precision biomarker-based testing for transplant and oncology care, and is relocating its headquarters from Irvine, California to Nashville, Tennessee.

Product Development and Exhibition Plans: iMDx is launching new product names under the GraftAssure brand and will showcase its GraftAssureIQ™ research-use-only kits at the European Society of Organ Transplantation conference in London, aiming to enhance collaboration in transplant medicine research.

New Pricing Announcement: Oncocyte Corp. has increased the reimbursement rate for its GraftAssureCore™ assay to $2,753, enhancing its market potential in transplant rejection testing and aligning with competitive technologies.

Future Developments: The company is preparing for FDA submission of its kitted product, GraftAssureDx, which aims to facilitate broader adoption of their technology in transplant centers once authorized.

Financial Performance: Oncocyte Corp. reported $2.1 million in pharma services revenue for Q1 2025, achieving a gross margin of 62%, up from 40% in the previous quarter, while also planning to advance their clinical molecular diagnostic test kit for transplant rejection testing and rename the company to reflect its broader market focus.

Clinical Trial and Product Development: The company has completed the design for its clinical trial and expects participation from three top U.S. transplant centers, aiming for FDA clearance of its transplant test kit by 2026, while also expanding its GraftAssure product line and enhancing operational efficiencies in its Nashville lab.

Clinical Trial Progress: Oncocyte Corp. has received approval from a central institutional review board for its clinical trial aimed at launching an organ transplant rejection monitoring test kit, with participation from three of the top 10 U.S. transplant centers.

Regulatory Pathway and Market Potential: The company is preparing for its final Q-sub meeting with the FDA to obtain regulatory authorization, with expectations that local testing could generate significant revenue and improve community care in the $1 billion annual market for transplant rejection testing.

Study Findings: Oncocyte Corp. published positive data from a study involving 131 kidney transplant patients, revealing a correlation between blood-derived cell-free DNA levels and organ rejection, which enhances understanding of transplant biology and supports the use of their proprietary test for monitoring high-risk patients.

Market Expansion Potential: The findings indicate opportunities for Oncocyte to expand its market by providing affordable and efficient testing solutions for long-term management of kidney transplant recipients, particularly those at high risk of rejection.

Oncocyte's Participation in Conference: Oncocyte Corp. will be represented by CEO Josh Riggs and CFO Andrea James at the 24th Annual Needham Virtual Healthcare Conference from April 7-10, 2025, where they will discuss the company's innovative diagnostic technologies and progress on a regulated organ transplant rejection monitoring test kit.

Company Overview and Products: Oncocyte specializes in diagnostics technology, offering tests like VitaGraft™ for organ transplantation monitoring and DetermaIO™ for assessing tumor responses to immunotherapies, aiming to enhance clarity and confidence for physicians and patients.