LANDMARK SHORE PUBLICATION SHOWS PATIENTS RECEIVING HEARTCARE EXPERIENCED EXCELLENT OUTCOMES WITH
FEWER BIOPSIES OVER TIME – Read More

LANDMARK SHORE PUBLICATION SHOWS PATIENTS RECEIVING HEARTCARE EXPERIENCED EXCELLENT OUTCOMES WITH FEWER BIOPSIES OVER TIME – Read More




What is HeartCare?

Provides a non-invasive, leading indicator of graft injury and immune activation/quiescence

Incorporates a multi-modality approach utilizing two complementary technologies

Provides peace-of-mind during surveillance

 

^ Post-transplant period 2-6 months
^^ Post-transplant period > 6months

* Clinical correlation is required
** As defined by their institutional protocol

Utilizes AlloMap Heart, an established standard in heart transplant

 

*References to ISHLT are offered solely to support AlloMap’s FDA indications and should not be construed as supporting any other use.

Clinicians Rely on HeartCare When Making Clinical Decisions

Patients monitored with HeartCare in SHORE had fewer biopsies over time, with fewest biopsies occurring in patients without dual positive HeartCare results.4

High AlloMap is >30 for 2-6 months or >34 for >6 months post-transplant.
AlloSure was defined as a level ≥0.20% at any time post-transplant.

Clinical Interpretation for HeartCare – ACR Surveillance

HeartCare helps clinicians precisely identify patients who are at higher risk of ACR.

The table is provided for informational purposes only and is not intended as medical advice. A physician’s test selection and interpretation, diagnosis, and patient management decisions should be based on his/her education, clinical expertise, current guidelines, and assessment of the patient.

This table is designed for the context of surveillance testing for ACR. For patients that are at risk of AMR or being tested in other clinical context, different guidance may apply. High AlloMap is ≥30 for 2-6 months or ≥34 for >6 months | High AlloSure is ≥0.20%.

HeartCare has been Clinically Validated in Multi-center Prospective Studies Including >4,500 Patients

2023 ISHLT Guidelines5 Support the Use of HeartCare in Routine Monitoring of Heart Transplant Patients

References to ISHLT are offered solely to support AlloMap’s FDA indications and should not be construed as supporting any other use. AlloMap should solely be used in conjunction with standard clinical assessment.

Dual Positive HeartCare Results Better Identify ACR than A Single Test Alone4

Results from SHORE demonstrate the utility of paired testing for ACR surveillance.

Dual Positive HeartCare Results Increased the Odds of ACR4 by ~4X

SHORE data demonstrates that paired molecular testing provides complementary information.

The chance of a biopsy revealing ACR is greater with a dual positive HeartCare than with either a high AlloMap or a high AlloSure alone (p<0.01).

Positive Likelihood Ratio gives the change in the odds of having a diagnosis in patients with a positive test. A LR+ is mathematically defined as sensitivity / (1-specificity) High AlloMap is: ≥30 for 2-6 months or ≥34 for >6 months | High AlloSure is ≥0.20%.

HeartCare Allows for a Reduction in Biopsies vs. GEP Alone Without Impacting Outcomes6

Post-transplant survival, rejection free survival and graft function were similar at 1 year, while requiring significantly fewer endomyocardial biopsies.

HeartCare cfDNA Chart

HeartCare cfDNA Chart

Sample Collection and Draw Instructions

HeartCare

Watch the HeartCare specimen collection and shipping video and download step by step instructions.

AlloMap

Watch the AlloMap specimen collection and shipping video and download step by step instructions.