Solid Organ Pipeline
Kidney Transplant
AlloMap Kidney
Gene-expression profiling test assesses the probability of allograft rejection for both antibody-mediated rejection (ABMR) and T cell-mediated rejection (TCMR).
HistoMap Kidney
Gene expression profiling technology for the identification of rejection type in formalin-fixed paraffin embedded (FFPE) biopsy tissue. A carefully selected set of over 700 genes is used to identify key genes expressed and associated with subtypes of rejection in kidney transplants. The panel also includes probes to detect common viral infections in transplantation. HistoMap Kidney will be designed to be a reproducible and quantifiable measurement that can easily integrate into existing workflows.
UroMap
Urine gene expression test designed to detect T-cell mediated rejection. UroMap measures RNA levels encoding for the CD3ε chain, interferon-inducible protein 10 (IP-10), 18S, and BKV-VP1 to help identify the probability of T-cell mediated rejection and BKV nephropathy.
Heart Transplant
AiCAV
Cardiac Allograft Vasculopathy Trajectory Tool (AI-CAV), is a digital tool that can predict the risk of developing cardiac allograft vasculopathy in heart transplant recipients.
HistoMap Heart
Gene expression profiling technology for the identification of rejection in heart transplant recipients using formalin-fixed paraffin embedded (FFPE) endomyocardial biopsies (EMBs). A carefully selected set of over 700 genes is used to identify key genes associated with subtypes of rejection and injury in heart transplants. HistoMap Heart will be designed to be a reproducible and quantifiable measurement that can be easily integrated into existing clinical workflows.
Additional Products
AlloSure is available for compassionate use in other organs.
Cell Therapy Pipeline
AlloCell
A highly sensitive NGS based surveillance solution for allogeneic cell therapy. AlloCell measures the amount of allogeneic cell therapy product relative to patient cells by targeted sequencing of genomic DNA, based on analysis of hundreds of SNPs found across the human genome.
Potential benefits of AlloCell include:
- Accelerated development of new therapy approaches
- Shortened clinical trials to drive better therapy outcomes
- Resource and cost savings through significantly fewer lab personnel and less DNA input
- AlloCell results use as a secondary endpoint in registrational trials
Hematopoietic Cell & Bone Marrow Transplant Pipeline
AlloHeme
A highly sensitive NGS-based surveillance solution for hematopoietic blood and marrow transplant. AlloHeme may be used to assess engraftment kinetics and support early relapse prediction from blood and bone marrow samples for patients in conjunction with standard clinical assessment.
Additional benefits of using AlloHeme include:
- Rapid turnaround time in CLIA/CAP/NY state accredited labs
- Chimerism results from whole blood, bone marrow, and cell subtypes CD3+, CD15+, CD33+, and CD34+
Solid Organ Studies
AlloSure Kidney + AlloMap Kidney Studies
KOAR Registry
A multicenter, prospective, observational registry designed to evaluate outcomes of kidney transplant recipients managed with AlloSure Kidney.
OKRA Registry
A multicenter, prospective, observational registry designed to evaluate outcomes of kidney transplant recipients managed with KidneyCare (AlloSure Kidney + AlloMap Kidney).
AlloSure Heart + AlloMap Heart Studies
SHORE Registry
A multicenter, prospective, observational registry designed to evaluate outcomes of heart transplant recipients managed with HeartCare (AlloSure Heart + AlloMap Heart).
AlloSure Lung + AlloMap Lung Studies
ALAMO Registry
A multicenter, prospective, observational registry designed to evaluate outcomes of lung transplant recipients managed with LungCare (AlloSure Lung + AlloMap Lung).
AlloSure Liver + AlloMap Liver Studies
MAPLE Registry
A multicenter, prospective, observational registry designed to correlate the results of LiverCare (AlloSure Liver + AlloMap Liver) with clinically significant events impacting post-transplant clinical outcomes, histological findings, and the development of de novo Donor Specific Antibody (DSA).
Hematopoietic Cell & Bone Marrow Transplant Studies
AlloHeme Studies
ACROBAT Registry
A multicenter, prospective, observational registry designed to assess chimerism and relapse post-bone marrow/HCT transplant of Allo-HCT transplant recipients managed with AlloHeme.
For information on how to participate in a clinical study, please contact clinicaltrials@caredx.com.