Monthly Archives: June 2019

Myelodysplastic Syndrome (MDS)

Myelodysplastic Syndrome (MDS)

MDS is defined as ineffective hematopoiesis characterized by adequate or increased hematologic elements in bone marrow with peripheral cytopenia. Therefore, the presence of cytopenia in one or more hematologic lines is necessary for the diagnosis of MDS. However, numerous reactive conditions other than MDS can cause cytopenia and these conditions must be distinguished from MDS. While dysplasia in hematologic cells is an indication of the diagnosis of MDS, the presence of mutations along with cytopenia is the most conclusive evidence for the diagnosis of MDS. Normal individuals above the age of 50 may show mutation in some genes (ASXL1, TET2, DNMT3, and TP53), however, the level (Variant allele frequency, VAF) […]

Genomic Testing Cooperative Receives Medicare (Palmetto GBA) Coverage for two NGS Hematology Molecular Profiling Tests Including Liquid Biopsy for Hematologic Neoplasms

Genomic Testing Cooperative Receives Medicare (Palmetto GBA) Coverage for two NGS Hematology Molecular Profiling Tests Including Liquid Biopsy for Hematologic Neoplasms

GTC Receives Medicare Coverage for 2 NGS Hematology Molecular Profiling Tests Including Liquid Biopsy for Hematologic Neoplasms Irvine, California– June 19, 2019 – Genomic Testing Cooperative, LCA announced that the Medicare Administrative Contractor Palmetto GBA (MolDx®) has finalized its review and has established coverage for two Genomic Testing Cooperative (GTC) hematology profiles: GTC-Hematology (177 gene DNA profiling) and GTC-Hematology Plus (177 gene DNA and 1408 gene RNA profiling). The two Comprehensive Genomic Profile (CGP) tests are designed to help Pathologists and Hematologists/Oncologists in establishing the precise diagnosis, prognosis and determine therapy in hematologic neoplasms. The GTC Hematology test (177 gene DNA Profile) can be performed on cell-free DNA (cf-DNA) from […]

Comprehensive PIK3CA Mutation Analysis

Comprehensive PIK3CA Mutation Analysis

  When you order GTC Breast Cancer Profile   The FDA has approved Piqray (alpelisib) tablets, to be used in combination with the FDA-approved endocrine therapy fulvestrant, to treat postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. FDA approval of the drug was based on detecting one of 11 frequent mutations in PIK3CA. Based on our data, these 11 mutations constitute only 62.83% of the mutation we detect when Next Generation Sequencing (NGS) is used. Abnormalities in PIK3CA have been reported in approximately 30% of patients with breast cancer. […]

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