Oncocyte Expands Market Opportunity for VitaGraft™ Kidney
Oncocyte (NASDAQ: OCX) announced expanded Medicare coverage for its VitaGraft Kidney diagnostic test, now including monitoring of patients with newly developed donor-specific antibodies (dnDSA+) for antibody-mediated rejection (AMR). The expansion follows a study showing VitaGraft can detect AMR up to 11 months earlier than standard care.
The coverage was confirmed under MolDX's Local Coverage Determination (LCD) and includes two Z-codes for improved accessibility. This expansion targets a significant market, as up to 20% of patients develop detectable DSA within five years post kidney transplant, representing over 10,000 patients annually in the US. Notably, 24% of patients with dnDSA lose their allograft within 3 years, compared to a 96% five-year survival rate for patients without DSA.
The company aims to commercialize its proprietary diagnostic technology that enables local laboratories to run kitted tests measuring donor-derived cell-free DNA (dd-cfDNA), offering a more affordable and faster alternative to current methods.
Oncocyte (NASDAQ: OCX) ha annunciato un ampliamento della copertura Medicare per il suo test diagnostico VitaGraft Kidney, che ora include il monitoraggio dei pazienti con anticorpi specifici per donatori recentemente sviluppati (dnDSA+) per il rigetto mediato da anticorpi (AMR). L'espansione segue uno studio che dimostra come VitaGraft possa rilevare l'AMR fino a 11 mesi prima rispetto alla cura standard.
La copertura è stata confermata nell'ambito della Determinazione Locale della Copertura (LCD) di MolDX e include due codici Z per una maggiore accessibilità. Questa espansione punta a un mercato significativo, poiché fino al 20% dei pazienti sviluppa DSA rilevabili entro cinque anni dopo il trapianto di rene, rappresentando oltre 10.000 pazienti all'anno negli Stati Uniti. È importante notare che il 24% dei pazienti con dnDSA perde il proprio allograft entro 3 anni, rispetto a un tasso di sopravvivenza del 96% a cinque anni per i pazienti senza DSA.
L'azienda mira a commercializzare la propria tecnologia diagnostica proprietaria che consente ai laboratori locali di eseguire test in kit per misurare il DNA libero derivato dal donatore (dd-cfDNA), offrendo un'alternativa più conveniente e veloce rispetto ai metodi attuali.
Oncocyte (NASDAQ: OCX) anunció una ampliación de la cobertura de Medicare para su prueba diagnóstica VitaGraft Kidney, que ahora incluye el monitoreo de pacientes con anticuerpos específicos de donantes recién desarrollados (dnDSA+) para el rechazo mediado por anticuerpos (AMR). La expansión sigue a un estudio que demuestra que VitaGraft puede detectar AMR hasta 11 meses antes que el tratamiento estándar.
La cobertura fue confirmada bajo la Determinación de Cobertura Local (LCD) de MolDX e incluye dos códigos Z para una mejor accesibilidad. Esta expansión apunta a un mercado significativo, ya que hasta el 20% de los pacientes desarrolla DSA detectables dentro de cinco años después del trasplante de riñón, lo que representa más de 10,000 pacientes anualmente en los EE. UU. Cabe destacar que el 24% de los pacientes con dnDSA pierden su aloinjerto dentro de 3 años, en comparación con una tasa de supervivencia del 96% a cinco años para los pacientes sin DSA.
La empresa busca comercializar su tecnología diagnóstica propietaria que permite a los laboratorios locales realizar pruebas en kit que miden ADN libre derivado del donante (dd-cfDNA), ofreciendo una alternativa más asequible y rápida en comparación con los métodos actuales.
온코사이트 (NASDAQ: OCX)가 비타그래프트 신장 진단 검사에 대한 메디케어 보장 확대를 발표했습니다. 이 보장은 이제 항체 매개 거부반응(AMR)에 대한 기증자 특이 항체(dnDSA+)를 새로 개발한 환자의 모니터링을 포함합니다. 이 확대는 비타그래프트가 표준 치료보다 11개월 더 일찍 AMR을 감지할 수 있다는 연구 결과에 따른 것입니다.
이 보장은 MolDX의 지역 보장 결정(LCD)에 따라 확인되었으며, 접근성을 높이기 위해 두 개의 Z 코드를 포함합니다. 이 확대는 시장에서 중요한 목표를 가지고 있으며, 신장 이식을 받은 후 5년 내에 감지 가능한 DSA가 발생하는 환자가 최대 20%에 달합니다. 이는 미국에서 매년 10,000명 이상의 환자를 의미합니다. 특히 dnDSA가 있는 환자의 24%는 3년 이내에 이식편을 잃게 되며, DSA가 없는 환자의 5년 생존율은 96%입니다.
회사는 기증자 유래의 자유 DNA(dd-cfDNA)를 측정하는 키트 검사를 실시할 수 있는 지역 실험실을 위한 독점 진단 기술을 상용화할 계획입니다. 이는 현행 방법보다 더 저렴하고 빠른 대안을 제공합니다.
Oncocyte (NASDAQ: OCX) a annoncé l'extension de la couverture Medicare pour son test diagnostique VitaGraft Kidney, qui inclut désormais le suivi des patients avec des anticorps spécifiques au donneur nouvellement développés (dnDSA+) pour le rejet médié par anticorps (AMR). Cette extension fait suite à une étude montrant que VitaGraft peut détecter l'AMR jusqu'à 11 mois plus tôt que les soins standard.
La couverture a été confirmée dans le cadre de la Détermination de Couverture Locale (LCD) de MolDX et comprend deux codes Z pour une meilleure accessibilité. Cette extension cible un marché significatif, car jusqu'à 20% des patients développent des DSA détectables dans les cinq ans suivant une transplantation rénale, représentant plus de 10 000 patients par an aux États-Unis. Notamment, 24 % des patients avec dnDSA perdent leur allogreffe dans un délai de 3 ans, par rapport à un taux de survie de 96 % sur cinq ans pour les patients sans DSA.
L'entreprise vise à commercialiser sa technologie diagnostique propriétaire permettant aux laboratoires locaux de réaliser des tests en kit mesurant l'ADN libre dérivé du donneur (dd-cfDNA), offrant une alternative plus abordable et plus rapide aux méthodes actuelles.
Oncocyte (NASDAQ: OCX) hat die erweiterte Medicare-Abdeckung für seinen diagnostischen Test VitaGraft Kidney angekündigt, die jetzt die Überwachung von Patienten mit neu entwickelten spenderspezifischen Antikörpern (dnDSA+) zur antikörpervermittelten Abstoßung (AMR) umfasst. Die Erweiterung folgt einer Studie, die zeigt, dass VitaGraft AMR bis zu 11 Monate früher als die Standardbehandlung erkennen kann.
Die Abdeckung wurde im Rahmen der lokalen Leistungsbestimmung (LCD) von MolDX bestätigt und umfasst zwei Z-Codes für eine verbesserte Zugänglichkeit. Diese Expansion zielt auf einen signifikanten Markt ab, da bis zu 20% der Patienten innerhalb von fünf Jahren nach einer Nierentransplantation nachweisbare DSA entwickeln, was über 10.000 Patienten jährlich in den USA bedeutet. Bemerkenswert ist, dass 24% der Patienten mit dnDSA innerhalb von 3 Jahren ihr Allotransplantat verlieren, verglichen mit einer Überlebensrate von 96% nach fünf Jahren bei Patienten ohne DSA.
Das Unternehmen plant, seine proprietäre Diagnosetechnologie zu kommercialisieren, die es lokalen Labors ermöglicht, Kit-Tests zur Messung von spendenabgeleitetem zellfreiem DNA (dd-cfDNA) durchzuführen, womit eine kostengünstigere und schnellere Alternative zu den aktuellen Methoden angeboten wird.
- Medicare coverage expansion increases addressable market by including dnDSA+ patient monitoring
- Clinical evidence shows detection of AMR up to 11 months earlier than current protocols
- Large market opportunity with over 10,000 potential patients annually in the US
- Test enables non-invasive monitoring, eliminating need for biopsies
- Coverage to high-risk patients, excluding routine surveillance testing
Insights
- Medicare coverage expanded following study showing that monitoring with Oncocyte’s assay significantly reduces time to rejection diagnosis in patients with newly developed donor-specific antibodies (DSA)
- MolDX confirms eligibility for billing under current Local Coverage Determination (LCD) and Z-Code
- Up to
20% of patients will have detectable DSA within the first five years post kidney transplant, representing greater than 10,000 patients per year in the US.1 From time of onset of dnDSA,24% of patients will lose their allograft within 3 years compared to the96% five-year allograft survival for patients without DSA.1 - Early detection of transplant rejection is growing in significance as novel therapeutic treatments show promising early results in antibody mediated rejection.
IRVINE, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Oncocyte Corp. (NASDAQ: OCX), a leader in diagnostic technology, today announced a significant milestone in the advancement of patient care for kidney transplant patients.
The Molecular Diagnostics program (MolDX) has confirmed the use of VitaGraft Kidney to monitor patients with newly developed donor-specific antibodies (dnDSA+) for antibody-mediated rejection (AMR). This achievement follows the publication of a groundbreaking study demonstrating VitaGraft Kidney’s ability to detect AMR in dnDSA+ patients up to 11 months earlier than the current standard of care.
"Kidney transplant management is changing. There are currently no approved medications for managing AMR. In the past year, we have supported two publications that show anti-CD38 therapies have a chance at treating the disease," said Oncocyte CEO Josh Riggs. "Assuming the data continue to prove out for those drugs, catching AMR as early as possible becomes critical, highlighting the importance of this claims expansion. We have now shown that you can use our test to both catch AMR early and monitor anti-CD38 therapy. Eventually, we expect to attach all these claims to our clinical kitted product that is currently in development."
For context, Oncocyte aims to deliver scientifically proven molecular diagnostic tests that can be run more affordably and more quickly at local laboratories. Oncocyte is at a pivotal stage in commercializing its proprietary diagnostic technology for use in organ transplant patients. Its technology is designed to enable local laboratories to run a kitted test that quantifies an established biomarker, donor-derived cell-free DNA (dd-cfDNA). Oncocyte’s scientists have played a pivotal role in establishing dd-cfDNA as a trusted biomarker, and the company now is commercializing a groundbreaking diagnostic test using this market-disruptive approach.
An affirmative initial Medicare coverage decision is a key milestone toward successfully commercializing an assay, and subsequent claims expansion grows the total addressable market for an assay. For VitaGraft Kidney, Palmetto GBA, the Medicare Administrative Contractor for the Centers for Medicare & Medicaid Services (CMS), first issued a positive coverage decision in August 2023, confirming that the test had met the criteria for coverage under MolDX: Molecular Testing for Solid Organ Allograft Rejection (L38568). (Palmetto administers the MolDX program to oversee claims processing and determine whether molecular diagnostic tests meet coverage criteria for Medicare reimbursement.)
This latest claims expansion grows the total number of testing opportunities.
Highlights:
- Expanded Medicare coverage under LCD L38568 now includes VitaGraft Kidney for organ rejection surveillance in dnDSA+ patients.
- Enables earlier detection of antibody-mediated rejection (AMR) without the need for invasive biopsies.
- Supported by clinical evidence demonstrating VitaGraft Kidney’s ability to identify AMR up to 11 months earlier than current protocols.
- Associated with two Z-codes for improved accessibility:
- Z01TT: VitaGraft Kidney – Baseline + First Plasma Test
- Z04D6: VitaGraft Kidney - Subsequent
- Expansion focuses on high-risk patients; the coverage does not extend to routine surveillance testing.
Citations:
- Company estimates based on Everly M, Rebellato M, Haisch C, et al. (2013). Incidence and Impact of De Novo Donor-Specific Alloantibody in Primary Renal Allografts. Transplantation Journal 95(3):410-417. (Link)
About VitaGraft Kidney™
VitaGraft Kidney is a non-invasive, blood-based transplant monitoring test that quantifies donor-derived cell-free DNA (dd-cfDNA) in kidney transplant recipients. Utilizing highly precise digital polymerase chain reaction (digital-PCR) technology, VitaGraft Kidney provides fast results and reliable diagnostic insights to help clinicians assess graft health and manage patient care proactively.
About Oncocyte
Oncocyte is a leading 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, Oncocyte’s commercialization efforts and progress with respect to its molecular diagnostic tests and its proprietary diagnostic technology for use in organ transplant patients, the expectation of successful commercialization and growth of the total addressable market for VitaGraft Kidney, 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.
FAQ
What is the new Medicare coverage expansion for Oncocyte's (OCX) VitaGraft Kidney test?
How much earlier can OCX's VitaGraft Kidney detect transplant rejection compared to standard care?
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What are the new Z-codes assigned to OCX's VitaGraft Kidney test?
