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     101  0 Kommentare Landmark Study Shows CareDx’s HeartCare Outperforms dd-cfDNA Alone in Identifying Rejection and Patients Experienced Excellent Outcomes with Fewer Biopsies

    CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced findings from the SHORE (Surveillance HeartCare Outcomes Registry) study, one of the largest heart transplant studies of its kind, published in The Journal of Heart and Lung Transplantation.

    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 and 40% 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 and 97% with normal allograft function at two years post-transplantation.

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    “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.

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    Landmark Study Shows CareDx’s HeartCare Outperforms dd-cfDNA Alone in Identifying Rejection and Patients Experienced Excellent Outcomes with Fewer Biopsies CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and …