Oncocyte Receives CMS Coverage for Kidney Transplant Diagnostic Test

Oncocyte Corporation (Nasdaq: OCX) has received Centers for Medicare & Medicaid Services (CMS) coverage for its VitaGraft Kidney™ diagnostic test from Palmetto GBA, confirming that the test has met the criteria for coverage under MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568). VitaGraft is the first digital-droplet PCR assay to receive coverage.

Josh Riggs, Oncocyte’s CEO, said, “VitaGraft is supported by over a decade of published clinical data in kidney, liver and heart recipients. Our technology has repeatedly delivered reliable results with fast turnaround time, representing a significant improvement to the standard of care for at-risk patients and those under long-term management.”

Highlights

Oncocyte’s VitaGraft Kidney blood test is designed to identify signs of graft damage in patients with clinical suspicion of rejection at least 12 days post-transplant. The test is currently available through an Early Access Program.

Oncocyte will present new interim data from an ongoing interventional kidney study at the European Society of Organ Transplantation conference in September.

Oncocyte expects initial revenue generation in Q1 2024.

Kidney transplants are the most common solid organ transplants representing almost 60% (~25,000) of all transplants done each year in the US.

VitaGraft Kidney addresses a $1B+ estimated kidney market that is part of a $2B+ estimated overall transplant market opportunity.

VitaGraft Liver, Oncocyte’s second transplant test, is currently under review for coverage at MolDX.

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: https://oncocyte.com/

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Oncocyte Receives CMS Coverage for Kidney Transplant Diagnostic Test

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