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Medicare Covering Epic Sciences ctDNA Breast Cancer Panel, MDxHealth's Select MDx Test

NEW YORK – Epic Sciences said on Wednesday that its 56-gene circulating tumor DNA (ctDNA) panel for genomic profiling of metastatic breast cancer has received a positive Medicare coverage decision from Palmetto GBA, a Medicare administrative contractor through the Molecular Diagnostics Services (MolDX) program.

Separately, MDxHealth said that the technical assessment process with MolDX for its Select MDx test has been successfully completed, and the test will be reimbursed by Medicare. MDxHealth acquired the Oncotype DX Genomic Prostate Score from Exact Sciences last year.

Epic's test is covered under a foundational LCD for Plasma-Based Genomic Profiling in Solid Tumors, while MDxHealth's test is covered under a foundational LCD for Molecular Biomarkers to Risk-Stratify Patients at Increased Risk for Prostate Cancer.

Under the LCD for Epic, which also covers Guardant360, Epic's panel is covered for Medicare beneficiaries who have metastatic breast cancer and for whom tissue-based, comprehensive genomic profiling is not feasible, among other criteria, Epic said.

The panel is a key component of the company's DefineMBC multiomic liquid biopsy test for patients with metastatic breast cancer.

DefineMBC is designed to use both cell-based and cell-free analyses to comprehensively profile metastatic breast cancer, and to monitor tumor evolution and treatment response when a tissue biopsy is unavailable.

"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," Epic CEO Lloyd Sanders said in a statement.

Mark Aguillard, Epic's chief commercial officer, said in an email that the test will be reimbursed at $1,943.21.

Epic Sciences recently raised $24 million in a series G financing round, with which it intends to continue developing DefineMBC.

Meanwhile MDxHealth's Select MDx is a urine-based mRNA test for evaluating a patient's risk for clinically significant prostate cancer. In a note to investors, William Blair analyst Andrew Brackmann noted that "specific pricing is yet to be officially determined, but we assume Medicare pricing to be cross-walked to the Bio-Techne ExoDx prostate test at $760."

In a statement, MDxHealth CEO Michael McGarrity said, "We believe our pre-biopsy Select MDx test, coupled with our post-biopsy Confirm MDx and Genomic Prostate Score tests, provides the most comprehensive and clinically actionable pathway for urologists and patients."