On January 10, 2020 Paradigm Diagnostics, Inc. reported that Palmetto GBA, the Medicare Administrative Contractor (MAC) for the Molecular Diagnostics MolDX program, has reviewed the technical dossier and broadly approved the Paradigm Cancer Diagnostic (PCDx) assay under the Local Coverage Determination for next-generation sequencing for solid tumors (Press release, Paradigm Diagnostics, JAN 10, 2020, View Source [SID1234552998]).

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The PCDx test provides physicians and their patients with a blueprint of the underlying mechanisms of a patient’s disease, potential treatment approaches, and inventory of relevant clinical trials. The test gets results back to physicians in three to five business days, rather than weeks. The PCDx assay detects substitutions, insertion and deletion alterations (indels), and copy number alterations in 234 genes and select gene rearrangements. PCDx also detects genomic signatures, including micro satellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens in addition to select immunohistochemistry tests.

"After an extensive technical review, the expanded Medicare coverage significantly enhances Paradigm’s ability to enable broader and earlier access to biomarker-driven treatments that may improve survival for cancer patients," said David Mallery, CEO.