Oncocyte dd-cfDNA Assay Detects Kidney Transplant Rejection 11+ Months Ahead of Standard Protocols, New Study Affirms
Oncocyte announced favorable data for its VitaGraft Kidney diagnostic assay, published in Nephrology Dialysis Transplantation. The study demonstrates the test can detect antibody-mediated rejection (AMR) in kidney transplant recipients approximately 11 months earlier than standard protocols. Using donor-derived cell-free DNA (dd-cfDNA) testing, VitaGraft diagnosed AMR in a median of 2.8 months compared to 14.5 months with standard care in patients with donor-specific antibodies. This marks the first randomized interventional study validating dd-cfDNA as a rule-in test for biopsy in high-risk populations.
Oncocyte ha annunciato dati favorevoli per il suo saggio diagnostico VitaGraft Kidney, pubblicati su Nephrology Dialysis Transplantation. Lo studio dimostra che il test può rilevare il rigetto mediato da anticorpi (AMR) nei trapianti di rene circa 11 mesi prima rispetto ai protocolli standard. Utilizzando il test del DNA libero da cellule derivate dal donatore (dd-cfDNA), VitaGraft ha diagnosticato AMR in una mediana di 2,8 mesi rispetto a 14,5 mesi con le cure standard in pazienti con anticorpi specifici per il donatore. Questo segna il primo studio interventistico randomizzato che convalida il dd-cfDNA come test di conferma per la biopsia in popolazioni ad alto rischio.
Oncocyte anunció datos favorables para su ensayo diagnóstico VitaGraft Kidney, publicado en Nephrology Dialysis Transplantation. El estudio demuestra que la prueba puede detectar el rechazo mediado por anticuerpos (AMR) en receptores de trasplante renal aproximadamente 11 meses antes que los protocolos estándar. Utilizando pruebas de ADN libre de células derivado del donante (dd-cfDNA), VitaGraft diagnosticó AMR en una mediana de 2,8 meses en comparación con 14,5 meses con atención estándar en pacientes con anticuerpos específicos del donante. Este es el primer estudio de intervención aleatorizado que valida el dd-cfDNA como prueba de confirmación para biopsias en poblaciones de alto riesgo.
온코사이트는 비타그래프트 신장 진단 검사에 대한 유리한 데이터를 발표했으며, 이는 Nephrology Dialysis Transplantation에 게재되었습니다. 이 연구는 이 검사가 신장 이식 수혜자에서 항체 매개 거부 반응(AMR)을 표준 프로토콜보다 약 11개월 더 일찍 탐지할 수 있음을 보여줍니다. 기증자 유래의 세포-free DNA(dd-cfDNA) 검사를 사용하여 비타그래프트는 기증자 특이 항체가 있는 환자에서 AMR을 평균 2.8개월에 진단한 반면, 표준 치료에서는 14.5개월이 소요되었습니다. 이는 고위험 집단에서 생검을 위한 확인 테스트로 dd-cfDNA를 검증한 첫 번째 무작위 개입 연구입니다.
Oncocyte a annoncé des données favorables pour son test diagnostique VitaGraft Kidney, publiées dans Nephrology Dialysis Transplantation. L'étude démontre que le test peut détecter le rejet médié par des anticorps (AMR) chez les receveurs de greffe rénale environ 11 mois plus tôt que les protocoles standards. En utilisant des tests d'ADN libre de cellules dérivées du donneur (dd-cfDNA), VitaGraft a diagnostiqué l'AMR à une médiane de 2,8 mois contre 14,5 mois avec les soins standards chez les patients présentant des anticorps spécifiques au donneur. Cela marque la première étude interventionnelle randomisée validant le dd-cfDNA en tant que test de confirmation pour la biopsie dans des populations à haut risque.
Oncocyte hat günstige Daten für seinen diagnostischen Test VitaGraft Kidney bekannt gegeben, die in Nephrology Dialysis Transplantation veröffentlicht wurden. Die Studie zeigt, dass der Test in der Lage ist, antikörpervermitteltes Abstoßen (AMR) bei Nierentransplantatempfängern etwa 11 Monate früher als die Standardprotokolle zu erkennen. Mithilfe von vom Spender abgeleitetem zellfreiem DNA (dd-cfDNA) -Test stellte VitaGraft AMR mit einer Median von 2,8 Monaten im Vergleich zu 14,5 Monaten bei der Standardversorgung bei Patienten mit spenderspezifischen Antikörpern fest. Dies markiert die erste randomisierte Interventionsstudie, die dd-cfDNA als Bestätigungstest für Biopsien in Hochrisikopopulationen validiert.
- Early detection capability: diagnoses rejection 11.7 months ahead of standard protocols
- First randomized interventional study validating dd-cfDNA as a rule-in test
- Potential revenue expansion through claims expansion with MolDX
- Strategic partnership secured for Phase II clinical trial testing
- Claims expansion with MolDX still pending approval
- current revenue potential due to restricted for-cause claim usage
Insights
The publication of this randomized interventional study marks a significant advancement in transplant diagnostics. The VitaGraft Kidney assay demonstrated remarkable capability by detecting antibody-mediated rejection (AMR) 11+ months earlier than standard protocols, with median detection times of 2.8 months versus 14.5 months.
The clinical implications are substantial: Earlier detection enables prompt intervention before irreversible organ damage occurs. This timing advantage becomes particularly relevant with emerging CD38-targeted therapies showing promise in treating AMR. The study's validation of dd-cfDNA as a rule-in test for biopsy in high-risk populations represents a paradigm shift in transplant monitoring.
For Oncocyte, potential claims expansion through MolDX could significantly broaden the commercial application beyond current for-cause testing, representing a meaningful market opportunity in the
This clinical validation strengthens Oncocyte's market position in the competitive transplant diagnostics space. The company's strategic positioning is enhanced by three key factors:
- First published randomized interventional data for biopsy rule-in
- Partnerships with pharmaceutical companies for therapeutic monitoring
- Potential coverage expansion through MolDX
The timing aligns well with emerging therapeutic options, positioning VitaGraft as a companion diagnostic tool. For a small-cap company (
- Oncocyte first to published randomized interventional data to rule-in for biopsy in high-risk patient population
- Study shows that monitoring with Oncocyte’s assay significantly reduces time to rejection diagnosis in patients with newly developed donor-specific antibodies
- Early detection of transplant rejection is growing in significance as novel therapeutic treatments show promising early results in antibody mediated rejection.
- Study published in Nephrology Dialysis Transplantation
IRVINE, Calif., Dec. 02, 2024 (GLOBE NEWSWIRE) -- Oncocyte Corp., (Nasdaq: OCX), a diagnostics technology company, today announced additional favorable data regarding its lead assay VitaGraft™, which was published in the journal, Nephrology Dialysis Transplantation.
VitaGraft Kidney™ quantifies the amount of DNA fragments in transplant patients’ blood that originate from the donor organ, a key biomarker for assessing graft health. This process is commonly referred to as donor-derived cell-free DNA (dd-cfDNA) testing and is widely used in clinical practice today. In this latest study, Oncocyte’s proprietary diagnostic dd-cfDNA test using digital PCR was able to diagnose antibody-mediated rejection (AMR) in kidney transplant recipients nearly a year ahead of standard protocols1.
“We are excited to see our dd-cfDNA technology demonstrate strong predictive value for AMR, supporting clinicians in identifying AMR in patients sooner, thereby enhancing the opportunity for better outcomes,” said Oncocyte Chief Science Officer Dr. Ekkehard Schuetz. “The trial’s results further validate dd-cfDNA as a critical biomarker that can bridge diagnostic gaps for transplant patients.”
For further context, de-novo donor specific antibody (dnDSA) is a routine biomarker used in kidney transplant management. The appearance of dnDSA in a patient -- that is, the patient is found to be dnDSA-positive (dnDSA+) -- signals an increased risk of AMR. This latest study shows that compared to standard of care, VitaGraft Kidney can significantly reduce the time to diagnosis of AMR in dnDSA+ patients. It is also the first randomized interventional study to validate any dd-cfDNA technology as a rule-in test for biopsy in a high-risk population.
Catching AMR early, when kidney graft loss can be minimized, is becoming increasingly important as physicians explore the use of drugs, including the anti-CD38 drugs felzartamab and daratumumab, to manage rejection. Monitoring with VitaGraft in this high-risk patient population could support early intervention with these new therapeutic options.
Once patients are on therapy, monitoring for therapeutic efficacy is also important to manage potential unwanted side effects. Publications using VitaGraft to monitor for efficacy for both aforementioned drugs can be found in the New England Journal of Medicine and Transplant International. In addition, earlier this year, Oncocyte signed an agreement with a European biotechnology company to be the provider of dd-cfDNA testing for a Phase II clinical trial for a separate therapeutic in AMR.
Oncocyte expects to submit for claims expansion to its payor, MolDX2, to support the use of VitaGraft for these high-risk patients in the clinic. If granted, it would expand the use case beyond the current for-cause claim, opening significant new revenue opportunities.
In sum, this clinical trial provides compelling evidence for dd-cfDNA monitoring as a tool for enhancing early intervention and improving outcomes for patients at increased risk of transplant rejection. Oncocyte scientists and inventors of the technology, Dr. Schuetz, Julia Beck and Kirsten Bornemann-Kolatzki, co-authored the study, which was initiated by researchers at Charité – Universitätsmedizin Berlin under the leadership of Prof. Klemens Budde. The study was published in Nephrology Dialysis Transplantation: Oxford Academic and may be found by accessing this link.
Additional study details: Highlighting potential for improved patient outcomes, as well as implications for broader clinical applications and future therapies
The interventional randomized trial, conducted between June 2021 and July 2023, involved 40 kidney transplant recipients with dnDSA, assessing longitudinal dd-cfDNA monitoring as a guiding tool for diagnostic biopsy compared to standard clinical practices. Oncocyte’s proprietary dd-cfDNA technology was able to detect the onset of AMR significantly earlier in patients by guiding the indication for biopsy (median time from inclusion to diagnosis: 2.8 months) compared to the control group using standard of care (14.5 months). As noted above, this early intervention could offer a valuable advantage in transplant care by enabling prompt treatment before irreversible damage occurs.
"This study underscores the impact of dd-cfDNA as a critical biomarker for early AMR detection, providing healthcare teams with timely data enabling them to initiate treatments sooner," said Dr. Aylin Akifova, first author from Charité.
This study also suggests that dd-cfDNA monitoring could also be instrumental in identifying subclinical AMR—a silent condition that, if undiagnosed, can lead to significant graft damage. Additionally, the findings come at a crucial time, as mentioned above, as promising new treatments, including CD38-targeted therapies, are showing unprecedented efficacy in treating AMR. Early diagnosis with dd-cfDNA could provide the earliest window for intervention, offering an advantage for patients suffering from AMR, a disease with historically very limited treatment options.
“We congratulate Charité’s research teams on these compelling findings, which further underscore our mission to empower clinicians with tools for precision diagnostics while also democratizing access to novel molecular diagnostic testing to improve patient outcomes,” said Josh Riggs, CEO of Oncocyte. “We look forward to expanding the clinical applications of dd-cfDNA technology and supporting transplant communities worldwide with our innovative diagnostic solutions.”
About Oncocyte
Oncocyte is a diagnostics technology company. The Company’s tests are designed to help provide clarity and confidence to physicians and their patients. VitaGraft™ is a clinical blood-based solid organ transplantation monitoring test. GraftAssure™ is a research use only (RUO) blood-based solid organ transplantation monitoring test. DetermaIO™ is a gene expression test that assesses the tumor microenvironment to predict response to immunotherapies. DetermaCNI™ is a blood-based monitoring tool for monitoring therapeutic efficacy in cancer patients. For more information about Oncocyte, please visit https://oncocyte.com/. For more information about our products, please visit the following web pages:
VitaGraft Kidney™ - https://oncocyte.com/vitagraft-kidney/
VitaGraft Liver™ - https://oncocyte.com/vitagraft-liver/
GraftAssure™ - https://oncocyte.com/graftassure/
DetermaIO™ - https://oncocyte.com/determa-io/
DetermaCNI™ - https://oncocyte.com/determa-cni/
VitaGraft™, GraftAssure™, DetermaIO™, and DetermaCNI™ are trademarks of Oncocyte Corporation.
CONTACT:
Jeff Ramson
PCG Advisory
(646) 863-6893
jramson@pcgadvisory.com
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, the expectation that Oncocyte will submit for claims expansion to MolDX to support the use of VitaGraft for high-risk patients in the clinic, which may expand the use case and open significant new revenue opportunities, the company’s anticipated expansion of clinical applications of dd-cfDNA technology, the company’s goal to support transplant communities worldwide with its innovative diagnostic solutions, 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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