Landmark Study Shows CareDx’s HeartCare Outperforms dd-cfDNA Alone in Identifying Rejection and Patients Experienced Excellent Outcomes with Fewer Biopsies
CareDx announced findings from the SHORE study, which demonstrates that its HeartCare diagnostic tool outperforms donor-derived cell-free DNA (dd-cfDNA) testing alone in identifying acute cellular rejection (ACR) in heart transplant patients.
The study, involving over 2,700 patients across 67 centers, shows that dual-negative HeartCare results correlate with the lowest ACR incidence at 1.5%, while dual-positive results have the highest at 9.2%.
Cardiologists performed the fewest biopsies following dual-negative results (8.8%), significantly lower than dual-positive results (35.4%). The study highlights reduced biopsy rates and excellent clinical outcomes, with a 95% survival rate and 97% normal allograft function at two years post-transplant.
This significant study, published in The Journal of Heart and Lung Transplantation, underscores the benefits of dual molecular testing for heart transplant patient monitoring.
- HeartCare showed a 1.5% incidence of ACR with dual-negative results, the lowest compared to other methods.
- Dual-positive HeartCare results identified the highest ACR incidence at 9.2%, improving risk stratification.
- Biopsy rates were lowest (8.8%) following dual-negative HeartCare results, reducing invasive procedures.
- Patients monitored with HeartCare had a 95% survival rate and 97% normal allograft function at two years post-transplant.
- Cardiologists performed 10% fewer biopsies in the first year and 40% fewer in the second year post-transplant with HeartCare.
- Dual-positive HeartCare results require more frequent follow-up biopsies (35.4%).
- Single positive HeartCare results still required a significant number of biopsies, though 56% lower than dual-positive results.
Insights
The SHORE study's findings are a significant leap in heart transplant care. The combination of AlloSure® Heart dd-cfDNA and AlloMap® Heart GEP in HeartCare® offers a robust approach to identifying acute cellular rejection (ACR) more accurately than dd-cfDNA alone. This dual testing method not only delivers more precise surveillance but also reduces the need for invasive biopsies, which are traditionally a stress factor for patients and carry inherent risks. Reduced biopsy rates can lead to fewer complications and lower healthcare costs over time. Moreover, the study's demonstration of excellent clinical outcomes, such as
While these results are promising, it's essential to consider the scalability and accessibility of such sophisticated testing methods across various healthcare settings. This innovation could redefine post-transplant monitoring protocols, setting a new standard in transplant medicine.
CareDx's innovative dual molecular testing via HeartCare® presents a compelling value proposition for the company. The SHORE study's outcomes imply that adoption of this technology could see a significant increase, driven by its demonstrated ability to improve patient outcomes and reduce the frequency of invasive biopsies. From a financial perspective, this could translate to higher revenues through increased sales of the HeartCare® test kits and possibly enhanced market share in the transplant diagnostics sector. Moreover, the reduction in biopsy-related costs could be a strong selling point to payers and healthcare providers.
However, investors should monitor the company's ability to scale production and distribution efficiently. The competitive landscape should also be considered, as advancements in transplant care are closely watched and rapidly evolving. The successful adoption of this technology in clinical settings will be important for sustained growth.
The SHORE study positions CareDx as a leader in the precision medicine market, particularly within the niche of transplant diagnostics. The demonstrated efficacy of HeartCare® in detecting ACR and reducing the need for biopsies can significantly enhance CareDx’s brand reputation and trust among healthcare professionals. This could lead to broader acceptance and integration of their tests into standard post-transplant care protocols across major transplant centers.
It’s also worth noting the potential for CareDx to expand its market reach internationally if regulatory approvals are pursued and granted. With healthcare systems worldwide seeking cost-effective and less invasive diagnostic tools, the global market opportunity for CareDx could be substantial. Strategic partnerships and collaborations could further accelerate adoption and market penetration.
HeartCare Results Effectively Stratified Patients at Highest Risk for Acute Cellular Rejection
Cardiologists Performed the Fewest Biopsies After Dual Negative HeartCare Results Compared to Single or Dual Positive Results
Two-Year Clinical Outcomes Data Demonstrate Excellent Survival and Allograft Function
The prospective observational study demonstrates that HeartCare® which combines AlloSure® Heart donor-derived cell-free DNA (dd-cfDNA) and AlloMap® Heart gene-expression profiling (GEP), identifies acute cellular rejection in heart transplant patients better than dd-cfDNA testing alone and is associated with fewer biopsies and excellent clinical outcomes.1
Key Findings from the SHORE Study Publication1:
-
Dual-positive HeartCare results are associated with the highest incidence (
9.2% ) of acute cellular rejection (ACR), whereas dual-negative HeartCare results are associated with the lowest incidence (1.5% ) of ACR. -
Follow-up endomyocardial biopsies (EMB) are performed at the lowest rate (
8.8% ) following a dual-negative HeartCare result, and at the highest rate (35.4% ) following a dual positive HeartCare result. -
The rate of biopsies performed in response to a single positive result is
56% lower than dual-positive HeartCare results. -
Clinician behavior to HeartCare results changed over time as centers gained experience with the testing. By the end of the study cardiologists performed
10% fewer biopsies in the first year post-transplant and40% fewer in the second year post-transplant despite an increase in follow-up biopsy rates for dual positives. -
Excellent clinical outcomes were observed in patients managed with HeartCare including fewer follow-up endomyocardial biopsies,
95% survival and97% with normal allograft function at two years post-transplantation.
“This large, prospective, multicenter study demonstrates that HeartCare significantly improves clinicians’ ability to assess acute cellular rejection risk and its use is associated with lower biopsy rates and excellent clinical outcomes two-years post-transplant,” said John W. Hanna, CareDx President and CEO.
“The SHORE study confirms the superior performance of dual molecular testing, combining donor-derived cell-free DNA and gene-expression profiling for acute cellular rejection surveillance in optimizing care for heart transplant patients. This approach allows for refined patient selection for surveillance biopsies, leading to fewer invasive procedures over time while maintaining vigilant ACR monitoring, and achieving excellent clinical outcomes,” said Kiran Khush, MD, MAS, Cardiologist, Professor of Cardiovascular Medicine, Stanford Medicine.
One of the largest heart transplant studies of its kind, SHORE is a prospective 67-center, observational study of over 2,700 heart transplant patients in
To read the publication, go here.
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 HeartCare, which combines AlloSure Heart donor-derived cell-free DNA (dd-cfDNA) and AlloMap Heart gene-expression profiling (GEP). 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 risks and uncertainties that could cause actual results to differ materially from those projected, including risks that CareDx does not realize the expected benefits of HeartCare, which combines AlloSure Heart donor-derived cell-free DNA (dd-cfDNA) and AlloMap Heart gene-expression profiling (GEP); risks that the findings in the SHORE study supporting the data may be inaccurate, 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 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. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.
References:
1. Khush K, Hall S, Kao A, et al. Surveillance with Dual Non-invasive Testing for Acute Cellular Rejection After Heart Transplantation: Outcomes from the Surveillance HeartCare Outcomes Registry (SHORE). The Journal of Heart and Lung Transplantation. Published online May 15, 2024. DOI: https://doi.org/10.1016/j.healun.2024.05.003
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CareDx, Inc.
Media Relations
Anna Czene
818-731-2203
aczene@caredx.com
Investor Relations
Greg Chodaczek
investor@caredx.com
Source: CareDx, Inc.
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