CareDx Announces Study Showing AlloSeq cfDNA Highly Accurate in Detecting Rejection in Organ Transplant Patients
CareDx (NASDAQ: CDNA) announced findings published in Transplant International showing that AlloSeq cfDNA's performance in detecting allograft rejection matches their established AlloSure test. The multicenter prospective study, involving 580 kidney transplant patients from three European transplant centers, demonstrated AlloSeq cfDNA's high accuracy in detecting kidney allograft rejection.
The study revealed a significant difference between rejection and non-rejection cases (p<0.0001) with an AUC of 0.758. AlloSeq cfDNA's performance was consistent with AlloSure Kidney across various clinical scenarios, including post-transplant timepoints, allograft stability, and rejection subcategories. This technology aims to provide early detection of rejection, allowing physicians to intervene before irreversible organ damage occurs.
AlloSeq cfDNA is CE-IVD marked and available in the EU and UK markets, where approximately 18,000 kidney transplants are performed annually. The product is not available in the US.
CareDx (NASDAQ: CDNA) ha annunciato risultati pubblicati su Transplant International che mostrano come le prestazioni di AlloSeq cfDNA nella rilevazione del rigetto dell'allotrapianto siano equivalenti a quelle del test AlloSure già consolidato. Lo studio prospettico multicentrico, che ha coinvolto 580 pazienti sottoposti a trapianto di rene provenienti da tre centri di trapianto europei, ha dimostrato l'alta precisione di AlloSeq cfDNA nel rilevare il rigetto dell'allotrapianto renale.
Lo studio ha rivelato una differenza significativa tra i casi di rigetto e quelli di non rigetto (p<0.0001) con un AUC di 0.758. Le prestazioni di AlloSeq cfDNA sono state coerenti con AlloSure Kidney in vari scenari clinici, inclusi i momenti post-trapianto, la stabilità dell'allotrapianto e le sottocategorie di rigetto. Questa tecnologia mira a fornire una rilevazione precoce del rigetto, consentendo ai medici di intervenire prima che si verifichino danni irreversibili all'organo.
AlloSeq cfDNA è contrassegnato CE-IVD ed è disponibile nei mercati dell'UE e del Regno Unito, dove vengono eseguiti circa 18.000 trapianti di rene all'anno. Il prodotto non è disponibile negli Stati Uniti.
CareDx (NASDAQ: CDNA) anunció hallazgos publicados en Transplant International que muestran que el rendimiento de AlloSeq cfDNA en la detección del rechazo del injerto coincide con su prueba AlloSure establecida. El estudio prospectivo multicéntrico, que involucró a 580 pacientes de trasplante de riñón de tres centros de trasplante europeos, demostró la alta precisión de AlloSeq cfDNA en la detección del rechazo del injerto renal.
El estudio reveló una diferencia significativa entre los casos de rechazo y no rechazo (p<0.0001) con un AUC de 0.758. El rendimiento de AlloSeq cfDNA fue consistente con AlloSure Kidney en varios escenarios clínicos, incluidos los momentos postrasplante, la estabilidad del injerto y las subcategorías de rechazo. Esta tecnología tiene como objetivo proporcionar una detección temprana del rechazo, permitiendo a los médicos intervenir antes de que ocurran daños irreversibles en el órgano.
AlloSeq cfDNA tiene marcado CE-IVD y está disponible en los mercados de la UE y el Reino Unido, donde se realizan aproximadamente 18.000 trasplantes de riñón anualmente. El producto no está disponible en los EE. UU.
CareDx (NASDAQ: CDNA)는 Transplant International에 발표된 결과를 통해 AlloSeq cfDNA의 이식편 거부 반응 감지 성능이 기존의 AlloSure 테스트와 일치함을 발표했습니다. 세 개의 유럽 이식 센터에서 580명의 신장 이식 환자를 대상으로 한 다기관 전향적 연구는 신장 이식편 거부 반응을 감지하는 AlloSeq cfDNA의 높은 정확성을 입증했습니다.
이 연구는 거부 반응과 비거부 반응 사례 간에 유의미한 차이(p<0.0001)를 보여주었고, AUC는 0.758이었습니다. AlloSeq cfDNA의 성능은 이식 후 시점, 이식편 안정성 및 거부 반응 하위 범주를 포함한 다양한 임상 시나리오에서 AlloSure Kidney와 일관성을 유지했습니다. 이 기술은 거부 반응의 조기 감지를 제공하여 의사가 되돌릴 수 없는 장기 손상이 발생하기 전에 개입할 수 있도록 하는 것을 목표로 합니다.
AlloSeq cfDNA는 CE-IVD 마크를 보유하고 있으며, 매년 약 18,000건의 신장 이식이 이루어지는 EU 및 영국 시장에서 사용할 수 있습니다. 이 제품은 미국에서는 사용할 수 없습니다.
CareDx (NASDAQ: CDNA) a annoncé des résultats publiés dans Transplant International montrant que la performance de AlloSeq cfDNA dans la détection du rejet de greffe correspond à celle de leur test AlloSure établi. L'étude prospective multicentrique, impliquant 580 patients ayant subi une greffe de rein de trois centres de transplantation européens, a démontré la haute précision d'AlloSeq cfDNA dans la détection du rejet de greffe rénale.
L'étude a révélé une différence significative entre les cas de rejet et ceux de non-rejet (p<0.0001) avec une AUC de 0.758. La performance d'AlloSeq cfDNA était cohérente avec AlloSure Kidney dans divers scénarios cliniques, y compris les moments post-greffe, la stabilité du greffon et les sous-catégories de rejet. Cette technologie vise à fournir une détection précoce du rejet, permettant aux médecins d'intervenir avant que des dommages irréversibles aux organes ne se produisent.
AlloSeq cfDNA est marqué CE-IVD et disponible sur les marchés de l'UE et du Royaume-Uni, où environ 18 000 greffes de rein sont réalisées chaque année. Le produit n'est pas disponible aux États-Unis.
CareDx (NASDAQ: CDNA) hat Ergebnisse veröffentlicht, die in Transplant International erscheinen, und zeigt, dass die Leistung von AlloSeq cfDNA bei der Erkennung von Organabstoßung mit dem etablierten AlloSure-Test übereinstimmt. Die multizentrische prospektive Studie, an der 580 Nierentransplantationspatienten aus drei europäischen Transplantationszentren beteiligt waren, zeigte die hohe Genauigkeit von AlloSeq cfDNA bei der Erkennung von Nierentransplantationsabstoßung.
Die Studie ergab einen signifikanten Unterschied zwischen Abstoßungs- und Nichtabstoßungsfällen (p<0.0001) mit einem AUC von 0.758. Die Leistung von AlloSeq cfDNA war in verschiedenen klinischen Szenarien konsistent mit AlloSure Kidney, einschließlich Nachtransplantationszeitpunkten, Stabilität des Transplantats und Abstoßungskategorien. Diese Technologie zielt darauf ab, eine frühzeitige Erkennung von Abstoßungen zu ermöglichen, sodass Ärzte intervenieren können, bevor irreversible Organschäden auftreten.
AlloSeq cfDNA ist CE-IVD-zertifiziert und auf den Märkten der EU und des Vereinigten Königreichs erhältlich, wo jährlich etwa 18.000 Nierentransplantationen durchgeführt werden. Das Produkt ist in den USA nicht erhältlich.
- Study validates AlloSeq cfDNA's effectiveness in detecting transplant rejection
- Strong statistical significance in study results (p<0.0001, AUC 0.758)
- Large-scale validation with 580 patients across three transplant centers
- Product available in significant market (EU/UK) with 18,000 annual kidney transplants
- Product not available in US market
Insights
The validation of AlloSeq cfDNA marks a significant milestone for CareDx's international expansion strategy. The study's robust design, involving 580 patients across three European transplant centers, provides compelling evidence that could accelerate market adoption. The test demonstrated an AUC of 0.758, indicating strong diagnostic accuracy in detecting organ rejection.
The timing is particularly strategic as it addresses a substantial market opportunity with approximately 18,000 annual kidney transplants in the European Union. Traditional rejection monitoring methods like serum creatinine and proteinuria are lagging indicators, creating a clear value proposition for AlloSeq's early detection capabilities. This could potentially position CareDx to capture a significant share of the European transplant diagnostics market.
The consistency between AlloSeq and AlloSure's performance is particularly noteworthy as it leverages AlloSure's established clinical validation, potentially accelerating physician adoption and payor acceptance. This validation could strengthen CareDx's pricing power and help establish AlloSeq as the standard of care in international markets.
The CE-IVD marking in the EU and UK provides immediate commercialization opportunities, though the absence of U.S. availability suggests a phased global expansion strategy. The ability to detect both clinical and subclinical rejection could lead to earlier interventions, potentially reducing healthcare costs associated with organ failure and retransplantation.
AlloSeq cfDNA Consistent with Performance of Proven AlloSure Testing
CareDx Brings Innovative Non-Invasive Transplant Monitoring to Patients Internationally with AlloSeq cfDNA
Kidney allograft rejection is the leading cause of graft failure in kidney transplant patients. Early identification and treatment of rejection is critical to reduce allograft injury and prevent irreversible damage to the transplanted organ. Traditional tests such as serum creatinine, proteinuria and the formation of donor specific antibodies (DSA) are lagging indicators of kidney allograft rejection. In this first large-scale comparative study of its kind, AlloSure and AlloSeq cfDNA demonstrate consistent performance in detecting both clinical and subclinical rejection.
“This large-scale multicenter study confirms that the AlloSeq cfDNA IVD kit performance in detecting allograft rejection is highly consistent with the broadly implemented and well-characterized AlloSure Kidney testing service,” said Dr. Alexandre Loupy, Professor of Nephrology and Epidemiology at the Necker Hospital, in
The multicenter prospective study included 580 kidney transplant patients from three referral transplant centers in
“This study demonstrates the strong performance of our AlloSeq cfDNA kit in assessing allograft rejection in kidney transplant patients,” said John W. Hanna, CareDx President and CEO. “We look forward to physicians’ use of this data to expand the use of our innovative, high-performance allograft monitoring solutions internationally. Approximately 18,000 kidney transplants are performed in the European Union annually. By identifying early signs of rejection with AlloSeq cfDNA, physicians can intervene earlier to prevent irreversible organ injury and failure and improve long-term outcomes for their patients.”
To read the publication, go here.
AlloSeq cfDNA is available with CE-IVD marking in the E.U. and in the
About CareDx – The Transplant Company
CareDx, Inc., headquartered in
Forward Looking Statements
This press release includes forward-looking statements related to CareDx, Inc., including statements regarding the potential benefits and results that may be achieved with AlloSeq cfDNA and AlloSure dd-cfDNA. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, all of which are difficult to predict and many of which are beyond CareDx’s control, that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of AlloSeq cfDNA or AlloSure or risks that the findings published in the Transplant International study supporting the data may be inaccurate. These statements are also subject to general economic and market factors; and other risks discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed by CareDx with the SEC on February 28, 2024, the Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed by CareDx with the SEC on May 9, 2024 and the Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2024 filed by CareDx with the SEC on July 31, 2024, the Quarterly Report on Form10-Q for the quarter ended September 30, 2024 filed by CareDx with the SEC on November 4, 2024, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
References:
- Loupy, A, Certain, A, Tangprasertchai, NS, et al. Evaluation of a Decentralized Donor-Derived Cell-Free DNA Assay for Kidney Allograft Rejection Monitoring. Transplant International (2024). DOI=10.3389/ti.2024.13919
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CareDx
Media Contacts
Anna Czene
818-731-2203
aczene@caredx.com
Investor Relations
Caroline Corner
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Source: CareDx, Inc.
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