Table 1.
Description of Molecular Diagnostics, Circulating Biomarkers, and Immunogenetic Modalities
| Technology | Description | Commercially Available Assay (Cost in USD*) |
|---|---|---|
| Donor-Derived Cell-free DNA (dd-cfDNA) | Circulating ~150 base pair nucleotide fragments measured as ratio of donor to recipient DNA or %dd-cfDNA | Allosure ($2,790) Prospera ($2,790) |
| Gene Expression Profiling (GEP) | 11-gene panel scored from 0 to 40, with 9 genes for normalization | AlloMap ($3,240) |
| Intragraft mRNA Transcripts | Gene expression profiling of endomyocardial biopsy tissue samples (includes nCounter research assay) | MMDx, Molecular Microscope ($3,159) |
| MicroRNA (miRs) | Circulating ~22 base pair non-coding RNA molecules | |
| Soluble Protein Biomarkers | Natriuretic peptides (BNP, NT-proBNP); markers of myocyte injury (troponin, high-sensitivity troponin); inflammatory markers (CRP, IL-6, others) | BNP and NT-proBNP ($39) cTnI, cTnT, hs-cTnI, hs-cTnT($12) CRP($13) IL-6 ($17) |
| Protein Expression Profiling | Multi-protein assay that can be evaluated for clinically relevant expression profiles (includes Olink® and Somascan® research assays) | |
| Exosomes | Extracellular vesicles that can be isolated and their encapsulated proteins and nucleic acids can be quantitated. | |
| Human Leukocyte Antigen (HLA) Antibodies | Pre- or post-transplant (donor-specific) antibodies to HLA antigens | HLA Typing ($780) HLA Antibody Screen ($64) Luminex HLA DSA Quantification ($680) |
| Non-HLA Antibodies | Angiotensin II type-I-receptor (AT1R), endothelin type A receptor, and major histocompatibility-complex class I-related chain A (MICA) | AT1R ($450) |
BNP, brain type natriuretic peptide; CRP, C-reactive protein, cTn, cardiac Troponin; PRA, panel reactive antibody; DSA, donor-specific antibody
*
cost data from 2023 Centers for Medicare & Medicaid Services Clinical Laboratory Fee Schedule11.