Solid Tumors

There are certain genes recurrently mutated in tumors of the central nervous system (CNS). Genomic DNA is isolated from formalin fixed paraffin embedded (FFPE) tumor tissue and the DNA sequence of targeted regions of the AKT1, ATRX, BRAF, CD274, CDK4, CDKN2A, CDKN2B, CIC, EGFR, FUBP1, H3F3A, IDH1, IDH2, MET, MYC, MYCN, NF1, NF2, PDGFRA, PIK3CA, PTEN, RB1, SMO, TERT and TP53 genes is determined using next-generation sequencing (NGS) technology.

disease state indication(s)
CNS tumors (especially gliomas)

clinical use
Diagnostic, Predictive, Prognostic
Central Nervous System (CNS) cancers are heterogeneous and historically were sub-classified based on histology. In recent years, genomic analyses have uncovered recurrent alterations that aid in the more precise distinction between phenotypically similar diagnostic entities. This new paradigm of integrating genetic information with morphology is reflected in the most recent World Health Organization (WHO) updates for classification of CNS tumors. NCCN Guidelines for CNS Cancers also recognize that molecular studies impact diagnosis, prognosis and therapy selection, as well as eligibility for clinical trials.

methodology/product platform
Capture-based, next-generation sequencing (NGS)

specimen type and requirements
Preferred: Two (2) formalin-fixed, paraffin-embedded tissue/fine needle aspirate (FFPE/FNA) blocks containing tumor tissue from recent surgery or biopsy or sixteen (16) 2x5 µm sections with accompanying H&E slide.
Acceptable Alternative: One (1) formalin-fixed, paraffin-embedded tissue/fine needle aspirate (FFPE/FNA) block containing tumor tissue from recent surgery or biopsy or eight (8) 2×5 µm sections with accompanying H&E slide.
Unacceptable: Specimens preserved in alternative (non-formalin) fixatives, decalcified specimens, fresh or frozen tissue.
Note: Use refrigerated cold pack for transport. Make sure cold pack is not in direct contact with specimen.
DO NOT FREEZE.

turnaround time
Global (TC & PC): 12 days

cpt code(s)
81445 (x1)

medicare moldx cpt code
Not applicable

regulatory classification
Laboratory developed test (LDT)

ordering option
Global (TC & PC)