Epic Sciences has developed DefineMBC, a novel metastatic breast cancer (MBC) test that includes both cell-based and cell-free analysis from a single blood draw, which provides comprehensive MBC profiling when a tissue biopsy result is not available.
“Tissue biopsy to confirm metastatic breast cancer diagnosis and to subtype the cancer is the established standard of care, but can be highly invasive, expensive to payers, and due to sampling and access limitations, tissue biopsy may not provide physicians with the information needed to guide therapy. DefineMBC uses both cell-based and cell-free analysis from a simple blood draw and provides information for optimal treatment decision making,” says Rick Wenstrup MD, Chief Medical Officer, Epic Sciences. “DefineMBC also enables better therapeutic decision making in more advanced MBC where tissue biopsy is not routinely performed but patients’ cancers often evolve due to the impact of targeted therapies, ongoing clonal variations, and other known cancer dynamics.”
DefineMBC combines several multi-analyte assay methods to perform comprehensive cancer profiling and has demonstrated impressive sensitivity, specificity, accuracy, and precision. The features of DefineMBC include:
- Detection of circulating tumor cells (CTCs), and quantification of ER and HER2 protein expression on those cells, through immunofluorescent staining combined with image analysis by an algorithm developed through advanced machine learning.
- Whole-genome sequencing of individual CTCs (called single-cell sequencing) to detect presence of amplified cancer-related genes through analysis of copy number variation provide Isolation and characterization of the copy number variation (CNV).
- Analysis of cell-free DNA (cfDNA) by next-generation sequencing (NGS) of 56 genes, the detection of genomic alterations [single nucleotide variants (SNVs), fusions, CNVs, microsatellite instability (MSI), and tumor mutational burden (TMB)]. Expanded coverage of up to 500 genes is available for research and biopharma trials.
“DefineMBC delivers on the full potential of liquid biopsy, ensuring no information is left behind,” says Lloyd Sanders, CEO and president at Epic Sciences. “We are excited about the positive impact this product can have on patient care as well as the opportunity to provide critical data to drug development efforts. We are now enrolling several community cancer centers into our Early Access Program for DefineMBC and expanding the menu of assays we offer to our pharmaceutical and research partners.