Oncocyte’s VitaGraft™ Kidney Used to Monitor Effect of Daratumumab on Anti-body Mediated Rejection in New Case Series Study
Oncocyte Corp. (Nasdaq: OCX) announced the publication of a case series study using its VitaGraft™ Kidney diagnostic test to monitor antibody-mediated rejection (AMR) in kidney transplant patients treated with daratumumab. The study showcases the test's potential to monitor anti-CD38 therapy efficacy. VitaGraft Kidney, a noninvasive biomarker, measures donor kidney DNA in patient blood post-transplantation.
Key findings include:
- Two patients with biopsy-confirmed chronic active AMR showed stabilized kidney function and decreased dd-cfDNA levels after daratumumab treatment
- Biopsies revealed complete or partial resolution of AMR activity
- This is the second study demonstrating VitaGraft Kidney's ability to monitor therapeutic efficacy
Oncocyte aims to improve graft longevity by enabling AMR detection, management, and monitoring. The company is commercializing its transplant product line, including VitaGraft™ and GraftAssure™ tests.
Oncocyte Corp. (Nasdaq: OCX) ha annunciato la pubblicazione di uno studio su casi clinici che utilizza il suo test diagnostico VitaGraft™ Kidney per monitorare il rigetto mediato da anticorpi (AMR) in pazienti trapiantati di rene trattati con daratumumab. Lo studio dimostra il potenziale del test nel monitorare l'efficacia della terapia anti-CD38. VitaGraft Kidney, un biomarcatore non invasivo, misura il DNA del rene del donatore nel sangue del paziente dopo il trapianto.
I risultati chiave includono:
- Due pazienti con AMR attivo cronico confermato da biopsia hanno mostrato una stabilizzazione della funzione renale e una riduzione dei livelli di dd-cfDNA dopo il trattamento con daratumumab
- Le biopsie hanno rivelato una risoluzione completa o parziale dell'attività dell'AMR
- Questo è il secondo studio che dimostra l'abilità di VitaGraft Kidney nel monitorare l'efficacia terapeutica
Oncocyte mira a migliorare la longevità del trapianto abilitando la rilevazione, gestione e monitoraggio dell'AMR. L'azienda sta commercializzando la sua linea di prodotti per il trapianto, compresi i test VitaGraft™ e GraftAssure™.
Oncocyte Corp. (Nasdaq: OCX) anunció la publicación de un estudio de serie de casos que utiliza su test diagnóstico VitaGraft™ Kidney para monitorear el rechazo mediado por anticuerpos (AMR) en pacientes de trasplante renal tratados con daratumumab. El estudio demuestra el potencial de la prueba para monitorear la eficacia de la terapia anti-CD38. VitaGraft Kidney, un biomarcador no invasivo, mide el ADN del riñón del donante en la sangre del paciente después del trasplante.
Los hallazgos clave incluyen:
- Dos pacientes con AMR crónico activo confirmado por biopsia mostraron función renal estabilizada y niveles reducidos de dd-cfDNA después del tratamiento con daratumumab
- Las biopsias revelaron una resolución completa o parcial de la actividad de AMR
- Este es el segundo estudio que demuestra la capacidad de VitaGraft Kidney para monitorear la eficacia terapéutica
Oncocyte busca mejorar la longevidad del injerto mediante la detección, gestión y monitoreo de AMR. La empresa está comercializando su línea de productos para trasplantes, incluidos las pruebas VitaGraft™ y GraftAssure™.
Oncocyte Corp. (Nasdaq: OCX)는 다라투무맙으로 치료받는 신장 이식 환자에서 항체 매개 거부 반응(AMR)을 모니터링하기 위해 VitaGraft™ Kidney 진단 테스트를 사용하는 사례 연구 발표를 발표했다. 이 연구는 테스트가 항-CD38 요법의 효능을 모니터링할 수 있는 잠재력을 보여준다. VitaGraft Kidney는 비침습적인 바이오마커로, 이식 후 환자 혈액 내 기증자 신장 DNA를 측정한다.
주요 발견 내용은 다음과 같다:
- 바이옵시로 확인된 만성 활성 AMR 환자 두 명이 다라투무맙 치료 후 안정된 신장 기능과 낮아진 dd-cfDNA 수준을 보였다.
- 바이옵시에서 AMR 활동의 완전 또는 부분적인 해결이 나타났다.
- 이는 VitaGraft Kidney가 치료 효과를 모니터링할 수 있음을 보여주는 두 번째 연구이다.
Oncocyte는 AMR 감지, 관리 및 모니터링을 통해 이식 수명을 개선하는 것을 목표로 하고 있다. 이 회사는 VitaGraft™ 및 GraftAssure™ 테스트를 포함한 이식 제품 라인을 상용화하고 있다.
Oncocyte Corp. (Nasdaq: OCX) a annoncé la publication d'une étude de cas utilisant son test diagnostique VitaGraft™ Kidney pour surveiller le rejet médié par anticorps (AMR) chez des patients ayant subi une greffe de rein traités par daratumumab. L'étude met en lumière le potentiel du test pour surveiller l'efficacité de la thérapie anti-CD38. VitaGraft Kidney, un biomarqueur non invasif, mesure l'ADN du rein du donneur dans le sang du patient après la transplantation.
Les principaux résultats incluent :
- Deux patients avec un AMR actif chronique confirmé par biopsie ont montré une fonction rénale stabilisée et des niveaux de dd-cfDNA réduits après le traitement par daratumumab
- Les biopsies ont révélé une résolution complète ou partielle de l'activité de l'AMR
- C'est la deuxième étude démontrant la capacité de VitaGraft Kidney à surveiller l'efficacité thérapeutique
Oncocyte vise à améliorer la longévité de la greffe en permettant la détection, la gestion et la surveillance de l'AMR. L'entreprise commercialise sa gamme de produits pour la transplantation, y compris les tests VitaGraft™ et GraftAssure™.
Oncocyte Corp. (Nasdaq: OCX) hat die Veröffentlichung einer Fallstudie bekannt gegeben, die ihren diagnostischen Test VitaGraft™ Kidney zur Überwachung von antikörpervermitteltem Abstoßung (AMR) bei mit Daratumumab behandelten Nierentransplantationspatienten einsetzt. Die Studie zeigt das Potenzial des Tests zur Überwachung der Wirksamkeit der anti-CD38-Therapie. VitaGraft Kidney, ein nicht-invasiver Biomarker, misst die DNA des Spenderorgans im Blut des Patienten nach der Transplantation.
Wichtige Ergebnisse umfassen:
- Zwei Patienten mit biopsiebestätigtem chronisch aktivem AMR zeigten eine stabilisierte Nierenfunktion und verringerte dd-cfDNA-Spiegel nach der Behandlung mit Daratumumab.
- Biopsien zeigten eine vollständige oder teilweise Auflösung der AMR-Aktivität.
- Dies ist die zweite Studie, die die Fähigkeit von VitaGraft Kidney zur Überwachung der therapeutischen Wirksamkeit demonstriert.
Oncocyte zielt darauf ab, die Lebensdauer des Transplantats zu verbessern, indem die Erkennung, Verwaltung und Überwachung von AMR ermöglicht wird. Das Unternehmen bringt seine Produktlinie für Transplantationen, einschließlich der Tests VitaGraft™ und GraftAssure™, auf den Markt.
- VitaGraft Kidney shows potential to monitor anti-CD38 therapy efficacy for antibody-mediated rejection (AMR)
- Case series study demonstrates VitaGraft Kidney's ability to detect treatment response and post-treatment graft recurrence
- VitaGraft Kidney received positive coverage determination from Palmetto GBA for Medicare reimbursement in 2023
- Oncocyte is commercializing its transplant product line, including VitaGraft™ and GraftAssure™ tests
- GraftAssure is being launched globally with support from Bio-Rad Laboratories
- None.
Insights
This case series study demonstrates the potential of VitaGraft™ Kidney as a non-invasive biomarker for monitoring antibody-mediated rejection (AMR) in kidney transplant patients. The test's ability to track donor-derived cell-free DNA (dd-cfDNA) levels before, during and after daratumumab treatment provides valuable insights into therapy efficacy. Notably, both patients showed stabilization of kidney function and dd-cfDNA levels below the clinical threshold for rejection post-treatment.
The study's significance lies in its potential to reduce the need for invasive biopsies and guide personalized treatment decisions. This could lead to improved graft longevity and patient outcomes. However, the small sample size (only two patients) limits the generalizability of these findings. Larger studies are needed to confirm the test's reliability and clinical utility across diverse patient populations.
Oncocyte's VitaGraft™ Kidney test shows promising commercial potential in the organ transplant diagnostics market. The positive coverage determination from Medicare in 2023 is a significant milestone, potentially driving adoption and revenue growth. The test's ability to monitor therapy response could expand its market reach beyond initial rejection diagnosis.
The partnership with Bio-Rad Laboratories for global commercialization of GraftAssure™ is strategically important, leveraging Bio-Rad's established distribution network. However, investors should note that Oncocyte is still in the early stages of commercialization. The company's focus on both transplant and oncology verticals diversifies its portfolio but may also strain resources. Financial performance and market penetration rates in the coming quarters will be important indicators of the company's growth trajectory and long-term viability.
Case Series represents second study showing VitaGraft Kidney as a measure of response to the benefit of therapy for one leading cause of allograft failure
IRVINE, Calif., Aug. 12, 2024 (GLOBE NEWSWIRE) -- Oncocyte Corp. (Nasdaq: OCX), a molecular diagnostics technology company, announced the recent publication of a case series of two kidney transplant patients who were monitored for antibody-mediated rejection (AMR) using its proprietary VitaGraft™ Kidney diagnostic test. Patients were tested before, during and after treatment with daratumumab, an anti-CD38 monoclonal antibody1. The study underscores the significant potential of using repeated VitaGraft Kidney measurements to monitor the efficacy of anti-CD38 therapy.
VitaGraft Kidney is a noninvasive biomarker2 that quantifies the concentration of donor kidney DNA in the patient’s blood after transplantation. This donor-derived cell-free DNA (dd-cfDNA) test is currently approved by CMS for identifying signs of graft damage in patients with clinical suspicion of rejection.
The case series reports on two patients with biopsy-confirmed chronic active AMR, one of the leading causes of allograft kidney failure, treated with monthly daratumumab infusions and monitored longitudinally with VitaGraft Kidney dd-cfDNA testing. After daratumumab treatment, both patients showed stabilization of kidney function parameters and a steep decline in dd-cfDNA levels below the clinical threshold for rejection. Biopsies six months after treatment demonstrated complete histologic resolution of AMR activity in one patient and partial resolution in the other. The patient with complete resolution showed a significant decline in dd-cfDNA levels to the lower limit of detection, and although the patient with partial improvement in AMR showed slightly higher dd-cfDNA levels, the patient still remained below the rejection threshold.
Today’s announcement represents the second publication that shows Oncocyte’s ability to monitor therapeutic efficacy. In a recent phase 2 randomized controlled trial published in The New England Journal of Medicine, VitaGraft Kidney was also used to measure the response to another anti-CD38 antibody, felzartamab, for patients with AMR after kidney transplantation. The study noted that dd-cfDNA levels after treatment corresponded to the rejection observed in biopsies at 52 weeks.
“VitaGraft Kidney has high potential to be the most useful biomarker for monitoring the effectiveness of anti-CD38 therapy for AMR,” said Dr. Ekkehard Schütz, Oncocyte’s Chief Science Officer and one of the authors of both studies. “This test could facilitate not only early diagnosis of AMR but also longitudinal measurements of treatment response and possible post-treatment graft recurrence over the long term.”
These new use cases could guide individual management decisions, such as dosing and duration of anti-rejection therapy, while reducing the need for repeated biopsies. By enabling detection, management and monitoring of AMR, VitaGraft could improve graft longevity.
Oncocyte’s mission is to democratize access to molecular diagnostic testing to improve patient outcomes. The company is investing in developing products to serve the separate verticals of organ transplant testing and oncology. Oncocyte presently is commercializing its transplant product line, which includes the VitaGraft™ and GraftAssure™ dd-cfDNA tests. Specifically, GraftAssure is being launched globally with the support of Bio-Rad Laboratories, a leading diagnostics equipment company. Oncocyte received a positive coverage determination from Palmetto GBA, a Medicare Administrative Contractor for the Centers for Medicare & Medicaid Services (CMS), for VitaGraft Kidney in 2023.
About Oncocyte
Oncocyte is a molecular 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.
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, VitaGraft Kidney’s potential utility, Oncocyte’s ongoing commercialization efforts, 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.
CONTACT:
Jeff Ramson
PCG Advisory
(646) 863-6893
jramson@pcgadvisory.com
1 CD38 is a protein found on the surface of many immune cells and targeted in some therapies for cancer. Daratumamab is a targeted cancer drug. Anti-CD38 antibodies such as daratumumab are being studied for the treatment of allograft injury and rejection mediated by immune cells that express CD38, such as natural killer cells in AMR.
2 VitaGraft Kidney measures the amount of DNA in transplant patients’ blood that comes 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. Oncocyte has previously demonstrated that VitaGraft Kidney can detect AMR up to 10 months earlier than current transplant rejection monitoring protocols.
FAQ
What is the purpose of Oncocyte's VitaGraft Kidney test in the recent case series study?
How did VitaGraft Kidney perform in monitoring AMR treatment response in the Oncocyte (OCX) case series?
What potential benefits does VitaGraft Kidney offer for kidney transplant patients according to the Oncocyte (OCX) study?
How does Oncocyte's VitaGraft Kidney test work to monitor kidney transplant patients?
