Product Pipeline: Innovation is Coming

K-OAR
A multicenter, prospective, registry study designed to evaluate outcomes of kidney transplant recipients managed with AlloSure Kidney.

OKRA
A multicenter, prospective, observational registry designed to evaluate outcomes of kidney transplant recipients managed with KidneyCare.

KIRA Study
Investigates the use of AlloSure to modulate patient immunosuppression levels to enhance outcomes.

TRACK Study
Investigates the use of AlloSure as a surveillance tool in the general nephrology setting.

Urine biomarker designed to detect acute rejection. UroMap measures messenger RNA (mRNA) levels encoding for the CD3ε chain, perforin, granzyme B, proteinase inhibitor 9, CD103, interferon-inducible protein 10 (IP-10), and the chemokine receptor CXCR3 to help to identify acute rejection.

Gene expression profiling technology for the identification of rejection in formalin-fixed paraffin embedded (FFPE) biopsy tissue. A carefully selected set of over 700 genes is used individually with each new organ type (kidney, heart, lung, and liver) to identify key genes expressed and associated with subtypes of rejection. The panel also includes probes to detect common viral infections in transplantation. HistoMap Kidney will be designed to be a reproducible, quantifiable measure that can improve workflow over similar technologies.

SHORE Study
A multicenter, prospective, observational registry designed to evaluate outcomes of patients receiving HeartCare surveillance.

MOSIAC
Investigating the use of AlloSure to modulate patient immunosuppression levels to enhance outcomes.

AiCAV
Cardiac Allograft Vasculopathy Trajectory Tool (AI-CAV), is a digital tool that can predict the risk of developing cardiac allograft vasculopathy and graft dysfunction in cardiac transplant recipients.

Gene expression profiling technology for the identification of rejection in formalin-fixed paraffin embedded (FFPE) biopsy tissue. A carefully selected set of over 700 genes is used individually with each new organ type (kidney, heart, lung, and liver) to identify key genes expressed and associated with subtypes of rejection. The panel also includes probes to detect common viral infections in transplantation. HistoMap Heart will be designed to be a reproducible, quantifiable measure that can improve workflow over similar technologies.

A clinically validated dd-cfDNA test for noninvasive surveillance of lung transplant patients, currently available for compassionate use.

ALAMO Study
A multicenter, registry study that is designed to investigate outcomes post lung transplantation using multimodality testing.

dd-cfDNA test for noninvasive surveillance of liver transplant patients, currently available under exploratory access.

Maple Study
The MAPLE Study is a multicenter observational cohort study to assess the correlation of clinically significant events with LiverCare in liver transplant recipients undergoing surveillance with molecular biomarkers. LiverCare includes 6 components which will be researched in this study:

• AlloSure Liver: donor-derived cell- free DNA (dd-cfDNA)
• AlloMap Liver: blood-based gene expression profiling (GEP)
• AlloHeme: micro-chimerism tool
• iBox Liver: machine learning algorithm to predict risk of clinical events and allograft outcomes
• HistoMap Liver: tissue-based gene expression profiling (GEP)
• AlloID: metagenomic infectious disease testing

AlloSure is available for compassionate use in other organs

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

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+

The ACROBAT Study
Assessment of Chimerism and Relapse Post Bone Marrow/Hematopoietic Cell Transplant (HCT) Using AlloHeme Test (ACROBAT) in AML, ALL and MDS patients.

Ottr SAAS
Cloud-based version of Ottr transplant management software – Now Available

AiTraC
Artificial intelligence tool for graft survival prognosis

For information on how to participate, please contact clinicaltrials@caredx.com