Oncocyte’s Proprietary Assay Demonstrates Long-Term Clinical Validity
Oncocyte (Nasdaq: OCX) has published new positive data on its blood-based transplant rejection assay in Transplantation Direct. The study, conducted at Charité University in Berlin, analyzed 131 patients with 151 kidney biopsies over four years, demonstrating long-term clinical validity for patients up to 13.7 years post-transplant.
The research revealed two key findings: 1) T-cell mediated rejection shows high elevation of dd-cfDNA when vascular inflammation is present, and 2) Calcineurin inhibitor toxicity doesn't increase dd-cfDNA levels. The study supports market expansion for testing high-risk patients, particularly those with de novo donor-specific antibodies.
Oncocyte is developing a kitted test for dd-cfDNA quantification and currently offers testing at its Nashville laboratory, which received Medicare reimbursement in 2023. The company aims to deliver more affordable, faster tests that can be run at local labs, positioning itself for commercial growth in transplant rejection monitoring.
Oncocyte (Nasdaq: OCX) ha pubblicato nuovi dati positivi sul suo test ematico per il rigetto del trapianto su Transplantation Direct. Lo studio, condotto presso la Charité University di Berlino, ha analizzato 131 pazienti con 151 biopsie renali in un arco di quattro anni, dimostrando la validità clinica a lungo termine per pazienti fino a 13,7 anni dopo il trapianto.
La ricerca ha evidenziato due risultati principali: 1) il rigetto mediato da cellule T mostra un elevato aumento di dd-cfDNA in presenza di infiammazione vascolare, e 2) la tossicità da inibitori della calcineurina non aumenta i livelli di dd-cfDNA. Lo studio supporta l'espansione del mercato per testare pazienti ad alto rischio, in particolare quelli con anticorpi specifici donatore de novo.
Oncocyte sta sviluppando un test kit per la quantificazione di dd-cfDNA e attualmente offre il test presso il suo laboratorio di Nashville, che ha ricevuto il rimborso Medicare nel 2023. L'azienda punta a fornire test più economici e rapidi, eseguibili nei laboratori locali, posizionandosi per una crescita commerciale nel monitoraggio del rigetto del trapianto.
Oncocyte (Nasdaq: OCX) ha publicado nuevos datos positivos sobre su prueba sanguínea para el rechazo de trasplantes en Transplantation Direct. El estudio, realizado en la Charité University de Berlín, analizó a 131 pacientes con 151 biopsias renales durante cuatro años, demostrando validez clínica a largo plazo en pacientes hasta 13,7 años después del trasplante.
La investigación reveló dos hallazgos clave: 1) El rechazo mediado por células T muestra una alta elevación de dd-cfDNA cuando hay inflamación vascular, y 2) La toxicidad por inhibidores de la calcineurina no aumenta los niveles de dd-cfDNA. El estudio respalda la expansión del mercado para pruebas en pacientes de alto riesgo, especialmente aquellos con anticuerpos específicos de donante de novo.
Oncocyte está desarrollando un test en kit para la cuantificación de dd-cfDNA y actualmente ofrece pruebas en su laboratorio de Nashville, que recibió reembolso de Medicare en 2023. La compañía busca ofrecer pruebas más asequibles y rápidas que puedan realizarse en laboratorios locales, posicionándose para un crecimiento comercial en el monitoreo del rechazo de trasplantes.
Oncocyte (나스닥: OCX)는 혈액 기반 이식 거부 검사에 관한 새로운 긍정적 데이터를 Transplantation Direct에 발표했습니다. 이 연구는 베를린 샤리테 대학에서 수행되었으며, 4년 동안 131명의 환자와 151건의 신장 생검을 분석하여 이식 후 최대 13.7년까지 장기 임상 유효성을 입증했습니다.
연구 결과 두 가지 주요 발견이 있었습니다: 1) 혈관 염증이 있을 때 T세포 매개 거부 반응은 dd-cfDNA가 크게 상승하며, 2) 칼시뉴린 억제제 독성은 dd-cfDNA 수치를 증가시키지 않습니다. 이 연구는 특히 신규 기증자 특이 항체를 가진 고위험 환자 검사 시장 확대를 뒷받침합니다.
Oncocyte는 dd-cfDNA 정량을 위한 키트형 검사를 개발 중이며, 현재 2023년에 메디케어 환급을 받은 내슈빌 실험실에서 검사를 제공하고 있습니다. 회사는 보다 저렴하고 빠른 검사를 지역 실험실에서 수행할 수 있도록 하여 이식 거부 모니터링 분야에서 상업적 성장을 목표로 하고 있습니다.
Oncocyte (Nasdaq : OCX) a publié de nouvelles données positives concernant son test sanguin de rejet de greffe dans Transplantation Direct. L'étude, menée à la Charité University de Berlin, a analysé 131 patients avec 151 biopsies rénales sur quatre ans, démontrant une validité clinique à long terme jusqu'à 13,7 ans après la transplantation.
La recherche a révélé deux résultats clés : 1) le rejet médié par les cellules T montre une forte élévation de dd-cfDNA en présence d'inflammation vasculaire, et 2) la toxicité des inhibiteurs de la calcineurine n'augmente pas les niveaux de dd-cfDNA. L'étude soutient l'expansion du marché pour tester les patients à haut risque, en particulier ceux avec des anticorps spécifiques du donneur de novo.
Oncocyte développe un test en kit pour la quantification de dd-cfDNA et propose actuellement des analyses dans son laboratoire de Nashville, qui a obtenu le remboursement Medicare en 2023. L'entreprise vise à offrir des tests plus abordables et rapides pouvant être effectués dans des laboratoires locaux, se positionnant pour une croissance commerciale dans la surveillance du rejet de greffe.
Oncocyte (Nasdaq: OCX) hat neue positive Daten zu seinem blutbasierten Test zum Nachweis von Transplantatabstoßungen in Transplantation Direct veröffentlicht. Die Studie, durchgeführt an der Charité Universität Berlin, analysierte 131 Patienten mit 151 Nierenbiopsien über vier Jahre und zeigte eine langfristige klinische Validität bei Patienten bis zu 13,7 Jahre nach der Transplantation.
Die Forschung ergab zwei wichtige Erkenntnisse: 1) Bei T-Zell-vermittelter Abstoßung steigt dd-cfDNA stark an, wenn eine Gefäßentzündung vorliegt, und 2) Eine Toxizität durch Calcineurin-Inhibitoren erhöht die dd-cfDNA-Werte nicht. Die Studie unterstützt die Markterweiterung für Tests bei Hochrisikopatienten, insbesondere solchen mit neu auftretenden donor-spezifischen Antikörpern.
Oncocyte entwickelt einen Kit-Test zur Quantifizierung von dd-cfDNA und bietet derzeit Tests in seinem Labor in Nashville an, das 2023 eine Medicare-Erstattung erhielt. Das Unternehmen strebt an, kostengünstigere und schnellere Tests anzubieten, die in lokalen Laboren durchgeführt werden können, um sich für das kommerzielle Wachstum im Bereich der Überwachung von Transplantatabstoßungen zu positionieren.
- Medicare reimbursement achieved for dd-cfDNA detection assay in August 2023
- Successful validation of test efficacy in long-term patients (up to 13.7 years post-transplant)
- Large clinical validation dataset of 131 patients with 151 kidney biopsies
- Test demonstrates potential for market expansion into high-risk patient monitoring
- Medicare reimbursement coverage expansion for claims approved for 2025
- Development of a potentially more affordable kitted version of the test for local labs
- Still in development phase for kitted test version
- Ongoing investigation needed for BK virus infection correlation
- Commercialization yet to reach full potential
Insights
Oncocyte's blood test for transplant rejection shows clinical validity up to 13 years post-transplant, supporting use in high-risk patients.
The publication in Transplantation Direct represents significant validation for Oncocyte's diagnostic approach to transplant rejection monitoring. The study's robust dataset of 131 patients with 151 kidney biopsies demonstrates the assay's clinical validity across an extended timeframe—1.6 to 13.7 years post-transplant—which is remarkable in transplantation diagnostics.
The study makes two novel observations with clinical implications: T-cell mediated rejection with vascular inflammation shows elevated dd-cfDNA levels, while calcineurin inhibitor toxicity does not increase dd-cfDNA. This differentiation capability is valuable for clinicians managing complex transplant cases, as it helps distinguish between rejection and medication toxicity—two conditions requiring fundamentally different interventions.
The focus on patients with de novo donor-specific antibodies (dnDSA+) is particularly important as these high-risk patients require more vigilant monitoring. Current transplant management relies heavily on invasive biopsies; a reliable blood test could significantly reduce procedure-related complications while enabling more frequent assessment.
This validation study builds on Oncocyte's previous work that led to Medicare reimbursement in 2023, creating a stronger foundation for clinical adoption. As emerging anti-CD38 therapies show promise for treating rejection, early detection becomes even more critical for improving long-term graft survival rates.
Oncocyte strengthens commercial position with clinical validation study supporting market expansion for transplant monitoring assay.
This publication represents a strategic advancement for Oncocyte's commercialization pathway in the organ transplant diagnostics market. The company is pursuing a dual-track strategy: offering a laboratory-developed test through their Nashville facility (already securing Medicare reimbursement in August 2023) while simultaneously developing a kitted version that can be run at local laboratories—a potential market disruptor in transplant diagnostics.
The study's long-term validation (patients up to 13.7 years post-transplant) significantly expands the potential customer base beyond newly transplanted patients to include the substantial population requiring ongoing monitoring. This positions Oncocyte to capture market share in both acute and chronic transplant management settings.
The collaborative research with Charité University in Berlin, a premier research institution, enhances Oncocyte's scientific credibility. More importantly, the study's focus on high-risk patients with donor-specific antibodies aligns with Oncocyte's strategic targeting of patient segments where testing frequency would likely be higher, potentially increasing test volumes and revenue.
Medicare reimbursement coverage expansion for 2025 mentioned in connection with high-risk patients suggests improving payor acceptance, a critical factor for diagnostic test adoption. While not explicitly stated, these developments collectively strengthen Oncocyte's competitive positioning in the transplant diagnostics market where early detection capabilities carry significant clinical and economic value.
Transplantation Direct publication uses assay to identify rejection in patients up to 13 years post-transplant
- Robust data set of 131 patients with 151 kidney biopsies enrolled over four years at Charité University in Berlin
- Supports market expansion for testing of high-risk patient population
- New findings advance understanding of the biology of organ rejection
IRVINE, Calif., April 29, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp., (Nasdaq: OCX), a leading diagnostics technology company, today announced the publication of new and positive data regarding its proprietary blood-based transplant rejection assay. The publication, “Association of Blood Donor-derived Cell-free DNA Levels with Banff Scores and Histopathological Lesions in Kidney Allograft Biopsies: Results From an Observational Study,” is co-authored by Oncocyte’s Drs. Ekke Schuetz and Julia Beck, inventors of the technology. Findings from the study bode well on both a strategic level for Oncocyte as well as on a scientific level for the transplant industry.
Scientifically, Oncocyte’s test is being used to help study the biology of organ rejection. The study revealed a correlation between microvascular and vascular inflammation and elevated dd-cfDNA in the blood plasma, contributing to the broader understanding of the pathophysiology of the analyte. Two novel observations from the study are described in more detail below, under “Scientific significance”. Strategically, the study highlights the opportunities for market expansion to monitor high-risk patients over the long-term.
“There are only a few publications on the dynamics of dd-cfDNA in other common pathologies beyond rejection,” said Oncocyte Chief Science Officer Dr. Schuetz. “Our study aimed to assess both the absolute and relative values of dd-cfDNA in diverse histopathological patterns, the correlation of dd-cfDNA with Banff lesion scores, and the recently suggested Banff-based activity and chronicity indices in consecutive cases of kidney transplant recipients undergoing indication biopsies.”
Oncocyte is at a pivotal stage in commercializing a potentially industry-transforming organ-transplant-rejection-monitoring test. The company aims to deliver proven, more affordable, faster tests that can be run at local labs. Specifically, Oncocyte is developing a kitted test that quantifies dd-cfDNA and plans to commercialize that technology using a market disruptive approach. In addition to developing a kitted version of its assay, Oncocyte also offers a dd-cfDNA-detection assay at its Nashville laboratory, which achieved Medicare reimbursement in August 2023.
“This latest publication comes from a long-standing research and collaborative relationship that we have with Charité University in Berlin, one of the leading research universities in the world,” Oncocyte CEO, Josh Riggs, said. “As they continue to advance the field’s scientific knowledge about transplantation, we are proud that our assay is being used to understand the fundamental biology at play in transplanted organ rejection.”
Strategic significance: Market expansion
This study builds upon the scientific foundation that supports long-term and aggressive management of high-risk patients, utilizing Oncocyte’s proprietary test.
First, the study’s size and duration validate that Oncocyte’s proprietary assay remains a clinically valid way to measure transplant health over the long term. Patients in the study were between 1.6 years to 13.7 years post-transplant. This means that over a decade into patient management, researchers were still seeing utility in dd-cfDNA testing.
Second, a significant percentage of the patients in the study with proven transplanted organ rejections also had de novo donor-specific antibodies (dnDSA+) in their blood. These types of patients are the same high-risk patients that Oncocyte identified in its groundbreaking prospective, randomized clinical trial study that was published in 2024, leading to Medicare reimbursement coverage expansion for claims in 2025.
“Data from this study reinforces that doctors should be routinely screening these high-risk patients with our test,” Mr. Riggs added. “Kidney transplant management is changing. Anti-CD38 therapies have a chance at treating transplant rejection. Assuming the data continue to be supportive, catching transplant rejection as early as possible becomes critical.”
Scientific significance: Novel observations
Two observations from the study are novel: 1) T-cell mediated rejection (TCMR) is associated with a high elevation of dd-cfDNA if vascular inflammation (vi) is present and 2) Calcineurin inhibitor (immunosuppressive medications) toxicity does not lead to an increase in dd-cfDNA levels.
In summary, dd-cfDNA seems to be a relatively specific biomarker for rejection, both antibody-mediated rejection (ABMR) and TCMR with vi. Why certain patients with BK virus infection also encounter an elevation of dd-cfDNA is currently under investigation.
Full Citation:
Akifova, Aylin MD1; Budde, Klemens MD1; Choi, Mira MD1; Amann, Kerstin MD2; Buettner-Herold, Maike MD2; Oellerich, Michael MD3; Beck, Julia PhD4; Bornemann-Kolatzki, Kirsten PhD4; Schütz, Ekkehard PhD4; Bachmann, Friederike MD1; Halleck, Fabian MD1; Schrezenmeier, Eva V. MD1; Seelow, Evelyn MD1; Zukunft, Bianca MD1; Hammett, Charlotte MD1; Pohl, Nathan A.1; Mordà, Benedetta MD1,5,6; Kowald, Jan MD7; Lachmann, Nils8; Stauch, Diana8; Osmanodja, Bilgin MD1. Association of Blood Donor-derived Cell-free DNA Levels With Banff Scores and Histopathological Lesions in Kidney Allograft Biopsies: Results From an Observational Study. Transplantation Direct 11(5):p e1794, May 2025. | DOI: 10.1097/TXD.0000000000001794
Link to study: https://journals.lww.com/transplantationdirect/fulltext/2025/05000/association_of_blood_donor_derived_cell_free_dna.9.aspx
About Oncocyte
Oncocyte is a pioneering diagnostics technology company whose mission is to democratize access to novel molecular diagnostic testing to improve patient outcomes. Investors may visit https://investors.oncocyte.com/ for more information.
Forward-Looking Statements
Any 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. These statements include those pertaining to, among other things, Oncocyte’s progress toward commercializing a potentially industry-transforming organ-transplant-rejection-monitoring test , and other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of diagnostic tests or products, uncertainty in the results of clinical trials or regulatory approvals, the capacity of Oncocyte’s third-party supplied blood sample analytic system to provide consistent and precise analytic results on a commercial scale, potential interruptions to supply chains, the need and ability to obtain future capital, maintenance of intellectual property rights in all applicable jurisdictions, obligations to third parties with respect to licensed or acquired technology and products, the need to obtain third party reimbursement for patients’ use of any diagnostic tests Oncocyte or its subsidiaries commercialize in applicable jurisdictions, and risks inherent in strategic transactions such as the potential failure to realize anticipated benefits, legal, regulatory or political changes in the applicable jurisdictions, accounting and quality controls, potential greater than estimated allocations of resources to develop and commercialize technologies, or potential failure to maintain any laboratory accreditation or certification. Actual results may differ materially from the results anticipated in these forward-looking statements and accordingly such statements should be evaluated together with the many uncertainties that affect the business of Oncocyte, particularly those mentioned in the “Risk Factors” and other cautionary statements found in Oncocyte’s Securities and Exchange Commission (SEC) filings, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Oncocyte undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
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dfarrell@lifesciadvisors.com
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