Oncocyte Starts FDA Submissions Process for Kidney Transplant Monitoring Test

Healthcare | Prism Market View

Precision diagnostics company, Oncocyte Corporation (Nasdaq: OCX), has initiated the FDA single-site process for its VitaGraft kidney transplant assays. This process is a well-established pathway for Lab Developed Tests (LDT) to seek regulatory approval. VitaGraft Kidney is a non-invasive, blood-based transplant monitoring test that assesses organ health and rejection risk status, post-transplantation. There is a significant unmet need for a regulated product in the $2 billion US testing market.

Josh Riggs, CEO of Oncocyte, said, “Establishing our VitaGraft Assay Lab Developed Test as a regulated device is good for patients and is a key part of our regulatory strategy. With minimal incremental investment, we can take a big step forward. Ultimately, we believe that FDA clearance will be a significant competitive advantage for us in the multi-billion-dollar transplant testing market and will drive adoption beyond the estimated 25-30% we see today.”


The initiation of the single-site process positions Oncocyte within the recent proposed rule from the FDA that seeks to propose greater oversight of LDTs and puts its lab-developed tests and kitted products on parallel paths.

In August 2023, Oncocyte received CMS coverage for its Vitagraft Kidney diagnostic test, which will be broadly available upon request once final reimbursement is established. Initial revenue from the service lab business is expected to begin in Q1 2024.

Oncocyte’s second transplant test, VitaGraft Liver, is currently under review for coverage at Molecular Diagnostic Services (MolDX).

The FDA Breakthrough Devices Program is a program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The program is intended to provide patients with more timely access to medical devices by expediting their development, assessment, and review.

About Oncocyte

Oncocyte is a precision diagnostics company. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients. VitaGraft™ is a blood-based solid organ transplantation monitoring test. DetermaIO™ is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies, and the pipeline test DetermaCNI™ is blood-based monitoring tool for assessing therapeutic efficacy. For more information, please visit: www.oncocyte.com

DetermaIO™, DetermaCNI™, and VitaGraft™ are trademarks of Oncocyte Corporation.


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Oncocyte Starts FDA Submissions Process for Kidney Transplant Monitoring Test

Catie Corcoran

Biotech Editor