Oncocyte study links blood test to kidney rejection markers

Published 29/04/2025, 13:40
Oncocyte study links blood test to kidney rejection markers

IRVINE, Calif. - Oncocyte Corp. (NASDAQ:OCX), a $92 million market cap diagnostics technology company, has unveiled new data supporting the effectiveness of its blood-based assay for transplant rejection, which could lead to broader market applications. Despite posting 25% revenue growth in the last twelve months, InvestingPro data shows the company faces challenges ahead, with analysts forecasting a sales decline this year. The study, recently published, demonstrates a correlation between levels of donor-derived cell-free DNA (dd-cfDNA) and specific biopsy markers in kidney transplant patients.

The research, conducted at Charité University in Berlin, involved 131 patients and 151 kidney biopsies over four years. It provided insights into the biology of organ rejection, particularly the association between dd-cfDNA levels and inflammation markers in kidney allograft biopsies.

Oncocyte’s Chief Science Officer, Dr. Ekke Schuetz, highlighted the study’s focus on diverse histopathological patterns and the correlation of dd-cfDNA with Banff lesion scores. The findings suggest that the company’s test could be a reliable long-term monitoring tool for high-risk transplant recipients.

Two key observations emerged from the study: T-cell mediated rejection is linked to increased dd-cfDNA levels when vascular inflammation is present, and calcineurin inhibitor toxicity does not cause a rise in dd-cfDNA levels. This points to dd-cfDNA as a specific biomarker for detecting both antibody-mediated and T-cell mediated rejections with vascular inflammation.

The study builds on previous research that led to Medicare reimbursement for Oncocyte’s dd-cfDNA-detection assay, which is currently offered at its Nashville laboratory. With a gross profit margin of 44%, CEO Josh Riggs expressed pride in the assay’s contribution to understanding organ rejection and emphasized the strategic importance of the test for market expansion and long-term patient management. InvestingPro subscribers can access additional insights, including 8 more ProTips and comprehensive financial analysis, to better understand the company’s growth trajectory.

Looking forward, Oncocyte aims to commercialize its testing technology with a kitted version of the assay, which could disrupt the market by offering a more affordable and locally available test option. With the company’s next earnings report due on May 9, 2025, investors can access detailed financial projections and expert analysis through InvestingPro’s comprehensive research reports, available for over 1,400 US stocks.

This press release statement serves as the basis for the reported facts, presenting Oncocyte’s developments in the transplant diagnostics industry without endorsing the company’s claims or future prospects. The study’s publication marks a significant step for Oncocyte as it seeks to establish its assay as a standard tool for transplant health monitoring.

In other recent news, OncoCyte Corporation reported its Q4 2024 earnings with a notable performance in its pharma services, achieving $1.5 million in revenue and a 40% gross margin. The company concluded the year with $10 million in cash reserves, further strengthened by a $29 million capital raise in February 2024. OncoCyte has been actively advancing its strategic initiatives, particularly in transplant testing, with the launch of its GraftAssure kidney transplant test. In corporate governance, OncoCyte appointed CBIZ CPAs P.C. as its new independent accounting firm, following the acquisition of Marcum LLP’s attest business by CBIZ CPAs.

Furthermore, Lake Street Capital Markets initiated coverage on OncoCyte with a Buy rating and a $5 price target, citing the company’s innovative approach in transplant rejection testing. Meanwhile, Needham maintained its Buy rating with a steady price target of $4.25, highlighting OncoCyte’s successful co-marketing efforts with Bio-Rad and its partnerships with transplant centers. OncoCyte is preparing for the anticipated launch of its GraftAssureDx Kidney kitted test, expected in the first half of 2026, pending FDA approval. These developments reflect OncoCyte’s ongoing efforts to strengthen its market position and financial management.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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