The test can detect early rejection episodes in organ transplant recipients using a digital polymerase chain reaction (dPCR) technique

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Oncocyte completes development of TheraSure transplant monitoring test for liver patients. (Credit: killy555 from Pixabay)

US-based precision diagnostics company Oncocyte has completed the development of its patent TheraSure transplant monitoring test for liver transplant patients.

TheraSure transplant monitor is a donor-derived cell-free DNA (dd-cfDNA) test that can detect early rejection episodes in organ transplant recipients using a digital polymerase chain reaction (dPCR) technique for timely post-transplant treatment modification to avoid organ damage.

The test has been verified in clinical cohorts in kidney, liver, and heart transplantation, said the firm.

The announcement indicates the completion of technology transfer and Oncocyte’s readiness to deploy TheraSure after Oncocyte acquired Chronix Biomedical.

Oncocyte president and CEO Ron Andrews said: “Today’s announcement marks the first product to be launched clinically from our Chronix acquisition completed in April 2021.

“The tech transfer of the proprietary blood-based technology used to develop TheraSure was an important undertaking for our R&D team in Germany and our CLIA lab team in Nashville, and I am extremely proud of the herculean effort put forth to meet the aggressive timeline we set last year to put us in a position to launch the liver indication in the first half of 2022.

“Management believes that the streamlined workflow developed by our two expert PCR development teams paves the way for expedited validation of TheraSure for kidney and heart transplants and prepares the Company for the important work ahead to convert the lab workflow into a kit.”

Oncocyte blood-based testing head Ekkehard Schutz said: “The anticipated speed and accuracy of dPCR testing, particularly the proprietary TheraSure Transplant Monitor test, are important attributes of our technology.

“We are thrilled to enable access to this test through our laboratory offering, meeting a truly unmet need for liver transplant patients and their physician care teams that are backed by peer-reviewed and published data.

“Today, there is no other alternative test for liver transplant patients, and I am proud of the lab team’s efforts to develop a workflow that can meet the goal of same day turnaround time of results once the blood sample is accessioned into our lab.

“Based on the successful validation of our dPCR workflow for TheraSure, we believe we can provide these results to certain transplant labs within one or two days of receipt of the blood sample to inform timely, critical medical decisions.”