HIGH PRECISION DIAGNOSTICS TRIAL

These statements include those pertaining to, among other things, the expectation that the Company will receive feedback from MolDx within 30, and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. VitaGraft™, DetermaIO™, and DetermaCNI™ are trademarks of Oncocyte Corporation.Īny statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” “may,” and similar expressions) are forward-looking statements.

and the pipeline test DetermaCNI™ is blood-based monitoring tool for monitoring therapeutic efficacy in cancer 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. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients. Oncocyte is a precision diagnostics company. Oncocyte has submitted its dd-cfDNA tests VitaGraft Kidney and Liver for Medicare reimbursement and expects its next feedback from Palmetto, which administers the MolDx Program, within 30 days. The application of dd-cfDNA testing in post-transplant patients represents a $2B market. The fact that our dd-cfDNA assay outperformed the established biomarkers used in the study for comparison is an important outcome for patient care,” said Ekke Schuetz, MD, PhD, CSO of Oncocyte. “I am excited by the outcome of this blinded study in a biopsy-controlled kidney transplantation cohort. Klemens Budde, MD, head of kidney transplantation in the Department of Nephrology at Charité Universitätsmedizin Berlin, which runs the largest transplant program in Germany. “This is an important study for clinicians because we now have a precise and noninvasive tool to better discriminate ABMR from other causes of kidney injury,” said Prof. In the paper, the authors highlight the limited value of currently marketed tests for the identification of treatable early-stage ABMR and suggest that dd-cfDNA testing could be a useful longitudinal management tool. Differentiating between recurring IgAN and ABMR could help physicians select the appropriate treatment for the patient more quickly, while potentially also avoiding unnecessary procedures and treatments. In the study, VitaGraft Kidney demonstrated higher sensitivity and specificity for detection of ABMR over routine tests (eGFR, uACR, DSA).

HIGH PRECISION DIAGNOSTICS TRIAL

This ongoing prospective, observational trial evaluated VitaGraft Kidney’s dd-cfDNA diagnostic technology as a tool to discriminate between recurrent IgAN and ABMR.

The data was published as a paper in the peer-reviewed journal Kidney International Reports. This is the first publication investigating this application of VitaGraft’s donor-derived cell-free DNA (dd-cfDNA) diagnostic technology for kidney transplant patients.

The test was able to distinguish between two prevalent causes of premature graft failure: biopsy-proven antibody-mediated rejection (ABMR) and recurrent IgA nephropathy (IgAN). IRVINE, Calif., J(GLOBE NEWSWIRE) - Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, today announced the publication of new data demonstrating VitaGraft Kidney’s novel ability to help physicians treat kidney transplant patients more precisely, quickly, and effectively. Paper published in peer-reviewed journal Improved utility over standard of care tests Blood-based test differentiates between ABMR and IgAN, enabling faster and more effective treatment

High precision diagnostics