Oncocyte Corporation announced that it has completed the development of its proprietary TheraSure Transplant Monitoring test for liver transplant patients. This announcement marks the successful completion of technology transfer and Oncocyte’s readiness to deploy TheraSure following the Company’s acquisition of Chronix Biomedical.

“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,” said Ron Andrews, President and CEO of Oncocyte. “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.”

The TheraSure Transplant Monitor, a donor-derived cell-free DNA (dd-cfDNA) test has shown to successfully achieve an early indication of rejection episodes in organ transplant patients using a digital polymerase chain reaction (dPCR) technique, may allow for timely post-transplant treatment modification to prevent organ damage. Oncocyte’s patented test has been validated in clinical cohorts that have been published in kidney, liver and heart transplantation.

“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 of this test through our laboratory offering, meeting a truly unmet need for liver transplant patients and their physician care teams that is backed by peer-reviewed and published data,” said Ekkehard Schutz, MD, PhD, FAACC, CTO and Head of Blood Based Testing at Oncocyte. “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.”