Paradigm Diagnostics, Inc. announced that Palmetto GBA, the Medicare Administrative Contractor for the Molecular Diagnostics MolDX program, has reviewed the technical dossier and broadly approved the Paradigm Cancer Diagnostic assay under the Local Coverage Determination for next-generation sequencing for solid tumors..
PHOENIX, Jan. 10, 2020 /PRNewswire/ -- Paradigm Diagnostics, Inc. announced 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.
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.
About Paradigm Diagnostics and Paradigm Cancer Diagnostic (PCDx) – Paradigm is an innovative precision medicine company that leverages technology, bioinformatics and proprietary sequencing to perform the PCDx test that identifies the evidence-based treatments that may improve a cancer patient’s progression-free survival. Paradigm delivers results in 3-5 business days and is able to provide comprehensive next-generation sequencing (NGS) results including mutational load off of a single slide. In an independent prospective study, using PCDx to help guide treatment decisions has been clinically proven to significantly increase progression-free survival. The company and its laboratory are based in Phoenix, Arizona.
For more information, please visit www.paradigmdx.com.
Paradigm Cancer Diagnostics (PCDx) is the trademark of Paradigm Diagnostics, Inc.
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SOURCE Paradigm Diagnostics
