TEST:

DefineMBC™

Recently, the novel anti-HER2 antibody-drug conjugate, Trastuzumab Deruxtecan (T-DXd), has shown effectiveness against MBC with low HER2 expression detected by tissue biopsy characterized as HER2-low (immunohistochemically 1+ or 2+ and ERBB2 amplification-negative via in situ hybridization) and is being explored in an ultra-low population...To date, studies with biomarker expression have been limited to tissue biopsy, which may not always yield contemporaneous sampling in the metastatic setting. These results offer a liquid biopsy test that might identify patients potentially responsive to HER2-directed therapies.

The results show a novel clinical assay which utilizes CTC protein detection as well as single-cell genomic analysis to identify tumors driven by basal-like cells. Generally, TNBC is classified with negative biomarker expression. We show that CTCs in TNBC display genomically basal-like cells.

DefineMBC identified HER2 expression by ctcIF with no ERBB2 amplification by ctcDNA or ctDNA, which is consistent with HER2-low in 29% (74/258) of patients with unknown IHC status, and 27% (20/73) in patients with HER2 0 by IHC and may indicate for T-DXd treatment. Conclusions A liquid biopsy platform combining ctcIF, ctcDNA, and ctDNA with high sensitivity and specificity can determine clinically actionable HER2 expression in MBC that can impact therapeutic decision-making for patients with MBC who do not have documented HER2 IHC expression or HER2 0 by IHC from a previous tissue biopsy.

"Epic Sciences, Inc. announced...that the company’s 56-gene ctDNA panel for genomic profiling of metastatic breast cancer is covered by the MolDX program (administered by Palmetto GBA) that provides coverage under the Medicare program for molecular diagnostic tests performed in our region. This panel is a key component of our comprehensive DefineMBC blood biopsy for metastatic breast cancer."

"Epic Sciences...has completed a $24 million Series G which together with its $43 million Series F financing, totals $67 million raised in the last twelve months. The company will use the capital from this additional round of private investment to fund the commercial infrastructure required to commercialize the three component tests of DefineMBC, which together provide a comprehensive blood-based biopsy result for patients with metastatic breast cancer."

"Epic Sciences, Inc...has completed a $43 million first close of its Series F financing. The company will use the capital from this additional round of private investment to continue to advance its multi-omic platform and expand operations in areas such as single-cell sequencing and data analytics infrastructure."

"Epic Sciences, Inc. has added DefineMBC™, a novel comprehensive blood-based test for characterizing metastatic breast cancer, to its CLIA laboratory menu...DefineMBC™ includes both cell-based and cell-free analysis from a single blood draw to provide comprehensive profiling of metastatic breast cancer when a tissue biopsy result is not available."

"Epic Sciences, Inc. today announced it has partnered with Fulgent Genetics...to deliver DefineMBC comprehensive profiling results for metastatic breast cancer (MBC) patients. The partnership links Fulgent’s leading CAP/CLIA certified Next Generation Sequencing services with Epic’s best-in-class cell analysis platform as part of Epic’s novel DefineMBC liquid biopsy test."

"Epic Sciences, Inc. announces DefineMBC, a novel metastatic breast cancer (MBC) test that includes both cell-based and cell-free analysis from a single blood draw. DefineMBC provides comprehensive MBC profiling when a tissue biopsy result is not available...DefineMBC combines several multi-analyte assay methods to perform comprehensive cancer profiling and has demonstrated impressive sensitivity, specificity, accuracy, and precision."