DeepSight™ Focused Liquid Biopsy

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.

Discover more.

A Model Experience

With core values rooted in service and integrity, our leadership team sets the bar high.

We consistently strive to set the model for exactly how a reference laboratory should engage with both physicians and patients.

Accredited and Certified

siParadigm is accredited by CLIA (Clinical Laboratory Improvement Amendments) and certified by CAP (College of American Pathologists).

We also hold select state licensure where required.