Alternative name:
Liquid Biopsy 50 Genes Panel
Methodology
Molecular
Test Description and clinical significance
Genes
DNA HOTSPOT GENES (45)
AKT1, AKT2, AKT3, ALK, AR, ARAF, BRAF, CDK4, CDKN2A, CHEK2, CTNNB1, EGFR, ERBB2, ERBB3, ERBB4, ESR1, FGFR1, FGFR2, FGFR3, FGFR4, FLT3, GNA11, GNAQ, GNAS, HRAS, IDH1, IDH2, KIT, KRAS, MAP2K1, MAP2K2, MET, MTOR, NRAS, NTRK1, NTRK2, NTRK3, PDGFRA, PIK3CA, PTEN, RAF1, RET, ROS1, SMO, TP53
CNV GENES (14)
ALK, AR, CD274, CDKN2A, EGFR, ERBB2, ERBB3, FGFR1, FGFR2, FGFR3, KRAS, MET, PIK3CA, PTEN
GENE FUSIONS
INTER-GENETIC FUSIONS GENES (16)
ALK, BRAF, ESR1, FGFR1, FGFR2, FGFR3, MET, NRG1, NTRK1, NTRK2, NTRK3, NUTM1, RET, ROS1, RSPO2, RSPO3
INTRA-GENETIC FUSIONS GENES (3)
AR, EGFR, MET
Disease:
Solid tumors
Oncomine™ Precision Assay GX panel that targets 50 genes and their relevant somatic mutations associated with clinical
and translational cancer research for solid tumors. Next generation sequencing (NGS) was performed on and analyzed
with the GenexusTM Integrated Sequencer. This panel can identify single nucleotide
variants (SNVs), insertion and deletions (INDELs), copy number variants (CNVs), and gene fusions. The limit of detection
for DNA variants (SNVs, INDELs) is 0.5% variant allele frequency at minimum 400X molecular read depth in the target
region, and copy number of 3 for CNV gain, 62 RNA fusion copies per ?L of RNA for gene fusion. Specificity of the assay
is expected to be > 99%.
Specimen Requirements
Collection:
Two-Three tubes of peripheral blood (10mL/tube) are collected in PAXgene Blood ccfDNA, For best results, a 21G or 22G needle is advised. Previously extracted cfDNA is acceptable. A minimum of 50 µL of each cfDNA with a
concentration of at least 0.60 ng/µ, corresponding to total at least 30ng of cfDNA,
fragment size between 100-200 bp, obtained on a TapeStation Cell-free DNA ScreenTape
or related instruments for assessment of cfDNA quality.
Stability:
48 hours
Unacceptable Conditions:
Do not freeze.
Specimen submitted is not in the PAXgene Blood ccfDNA tube or in the PAXgene Blood
ccfDNA tube after expired date.
Storage & Transport
Store tubes within the recommended temperature range
(18°C to 25°C) within 2 days, including shipping.
CPT(s)
81445 and G0452(26).
New York Approved
No
TAT
4-5 days
*The CPT codes provided are for informational purposes only and are based on AMA guidelines The billing party is solely responsible for correct CPT coding.
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