Epic Sciences Announces Medicare Coverage for Breast-Cancer Focused ctDNA Gene Panel

The 56-gene ctDNA panel is a key component of DefineMBC™, the company’s comprehensive blood biopsy for metastatic breast cancer

Epic Sciences, Inc. announced today 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.

Under the Medicare coverage policy Epic’s ctDNA panel is covered for Medicare beneficiaries who meet the criteria for coverage which include those patients who have metastatic breast cancer and for whom tissue-based, comprehensive genomic profiling is infeasible. The full list of coverage criteria is available on the MolDX website.

“We are pleased that Medicare has recognized the clinical value for patients of Epic’s non-invasive ctDNA test, which ultimately will help oncologists make more informed treatment decisions for their patients with metastatic breast cancer,” said Lloyd Sanders, Epic Sciences’ CEO. “We are working on submitting additional evidence to establish Medicare coverage on the entirety of Epic’s DefineMBC blood biopsy tests so that the full benefit of its comprehensive analysis can be available to patients with metastatic breast cancer.”

The 56-gene panel was developed to deliver to physicians information about genomic variants that are critical to the management of patients with metastatic breast cancer.

Since the launch of the company’s Clinical Experience Program in April of 2022, DefineMBC test results, including this 56-gene panel, have been delivered to over 700 patients with metastatic breast cancer. Survey results from physicians in the Clinical Experience Program show that 82% found the comprehensive results provided by DefineMBC to be clinically valuable in guiding care, and 88% prefer DefineMBC to more traditional ctDNA-only liquid biopsies.

About DefineMBC

DefineMBC includes both cell-based and cell-free analysis from a single blood draw to provide comprehensive metastatic breast cancer profiling when a tissue biopsy result is not available. The test’s multi-analyte methods have demonstrated sensitivity, specificity, accuracy, and precision in the:

• detection of circulating tumor cells (CTCs)
• assessment of HER2 protein expression
• single-cell sequencing of identified cells to assess amplification of the ERBB2 gene locus
• assessment of ER protein expression
• a plasma-based, 56-gene ctDNA panel that detects relevant genomic variants, tumor mutational burden (TMB), and microsatellite instability (MSI) in metastatic breast cancer

About Epic Sciences

Epic Sciences, Inc. is developing novel diagnostics to guide therapy selection and monitor disease progression, personalizing and advancing the treatment and management of prostate and breast cancer. The company’s liquid biopsy platform leverages proven, proprietary cell analysis capabilities as well as cell-free analysis to provide more efficient analysis and clearer insights – Comprehensive Cancer Profiling. Using its full-service CAP/CLIA-accredited laboratory and research support services, Epic Sciences partners with leading pharmaceutical companies and major cancer centers around the world to improve patient outcomes.

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