Collect

FIXED (any specimen type):
  • tissue, paraffin emedded block
  • tissue, unstained slides (USS)
    • 5 USS cut 5-10um thick tumor tissue (at least 5x5mm, preferably 10x10mm)
RECOMMENDATIONS:  Send accompanying H&E
 

Unacceptable Conditions

  • Paraffin blocks with low tumor percentage
  • Tissue fixed in heavy metal fixative
  • Decalcified tissue

Storage/Transport Temperature

Ambient temperature

Performed

Molecular Diagnostics

Notes

TEST DESCRIPTION:  The Solid Tumor Precision Panel is for assessment of molecular genetic biomarker targets for FDA-approved therapies in solid tumors.   This gene panel will assess 49 genes (see below) for somatically-derived, selected hotspot mutations including single nucleotide variants [SNVs], small insertions or deletions [indels], copy number variations [CNV] and structural variants [inter-genetic and intra-genetic fusions]. 

TEST DETAILS:  Hotspot regions in the following genes are tested for variants with potential clinical utillity.

SNVs and Indels (DNA)-
ATK1 CDKN2A FGFR1 HRAS MTOR RAF1
AKT2 CHECK2 FGFR2 IDH1 NRAS RET
AKT3 CTNNB1 FGFR3 IDH2 NTRK1 ROS1
ALK EGFR FGFR4 KIT NTRK2 SMO
AR ERBB2 FLT3 KRAS NTRK3 TP53
ARAF ERBB3 GNA11 MAP2K1 PDGFRA  
BRAF ERBB4 GNAQ MAP2K2 PIK3CA  
CDK4 ESR1 GNAS MET PTEN  

CNVs (DNA)-
CDKN2A del
PTEN del
EGFR amp
ERBB2 amp
FGFR1 amp
MET amp

Fusions (RNA)-
ALK MET RSPO2
AR NRG1 RSPO3
BRAF NTRK1  
EGFR NTRK2  
ESR1 NTRK3  
FGFR1 NUTM1  
FGFR2 RET  
FGFR3 ROS1  

Note:  This assay is designed to identify well-characterized Tier 1 and Tier 2 hotspot variants [CAP/ASCO/AMP Guidelines; Li, M. et. al. JMD 2017 19(1):4-23] and does not assess full genes.  For specific gene panel coverage information, please contact the laboratory.

LIMITATIONS: The following limits of detection have been validated for this assay.
VARIANT TYPE: LIMIT OF DETECTION:
Single Nucleotide Variants  5% variant allele fraction (20% tumor cellularity preferred)
Small Indels (<15 base pairs) 5-10% variant allele fraction (20% tumor cellularity)
Large Indels (>15 base pairs) Limit of Detection has not been established
Copy Number Amplifications 15% tumor cellularity
Copy Number Losses (CDKN2A and PTEN genes only) 70% tumor cellularity
Inter-genetic and Intra-genetic Fusions 30% tumor cellularity

RECOMMENDATIONS:  This new gene panel is especially recommended for the subpanel tumor types (Lung, Colorectal, Melanoma, Gastrointestinal stromal tumors-GIST).  Other panel testing may be indicated for certian solid tumors (e.g. ovarian, endometrial, breast, prostate), depending on therapeutic considerations (e.g. PARP inhibitors, etc.).
 

Ordering Recommendations

Replaces the 50 Gene Cancer Panel, Lung Cancer Panel, Colorectal Panel, Melanoma Panel, and the Gastrointestinal stromal tumors-GIST panel)

Performed

Molecular Diagnostics

Synonyms

  • Lung Cancer (ALK, ROS1, RET)
  • Colorectal Cancer (BRAF, CHEK2, HRAS, KRAS, NRAS, PIK3CA)
  • Melanoma (BRAF, GNA11, GNAQ, HRAS, KIT, NRAS)
  • Gastrointestinal stromal tumors (BRAF, KIT, PDGFRA)
  • GIST
  • Ovarian
  • Endometrial
  • Breast Cancer
  • Prostate Cancer

CPT Codes

81445
*This test will either require prior authorization or a signed ABN

Test Build Information

OrderCode OrderName ResultCode ResultName CPT
STPP Solid Tumor Precision Panel STPPR Solid Tumor Precision Panel 81445
Collection

Collect

FIXED (any specimen type):
  • tissue, paraffin emedded block
  • tissue, unstained slides (USS)
    • 5 USS cut 5-10um thick tumor tissue (at least 5x5mm, preferably 10x10mm)
RECOMMENDATIONS:  Send accompanying H&E
 

Unacceptable Conditions

  • Paraffin blocks with low tumor percentage
  • Tissue fixed in heavy metal fixative
  • Decalcified tissue

Storage/Transport Temperature

Ambient temperature

Performed

Molecular Diagnostics

Notes

TEST DESCRIPTION:  The Solid Tumor Precision Panel is for assessment of molecular genetic biomarker targets for FDA-approved therapies in solid tumors.   This gene panel will assess 49 genes (see below) for somatically-derived, selected hotspot mutations including single nucleotide variants [SNVs], small insertions or deletions [indels], copy number variations [CNV] and structural variants [inter-genetic and intra-genetic fusions]. 

TEST DETAILS:  Hotspot regions in the following genes are tested for variants with potential clinical utillity.

SNVs and Indels (DNA)-
ATK1 CDKN2A FGFR1 HRAS MTOR RAF1
AKT2 CHECK2 FGFR2 IDH1 NRAS RET
AKT3 CTNNB1 FGFR3 IDH2 NTRK1 ROS1
ALK EGFR FGFR4 KIT NTRK2 SMO
AR ERBB2 FLT3 KRAS NTRK3 TP53
ARAF ERBB3 GNA11 MAP2K1 PDGFRA  
BRAF ERBB4 GNAQ MAP2K2 PIK3CA  
CDK4 ESR1 GNAS MET PTEN  

CNVs (DNA)-
CDKN2A del
PTEN del
EGFR amp
ERBB2 amp
FGFR1 amp
MET amp

Fusions (RNA)-
ALK MET RSPO2
AR NRG1 RSPO3
BRAF NTRK1  
EGFR NTRK2  
ESR1 NTRK3  
FGFR1 NUTM1  
FGFR2 RET  
FGFR3 ROS1  

Note:  This assay is designed to identify well-characterized Tier 1 and Tier 2 hotspot variants [CAP/ASCO/AMP Guidelines; Li, M. et. al. JMD 2017 19(1):4-23] and does not assess full genes.  For specific gene panel coverage information, please contact the laboratory.

LIMITATIONS: The following limits of detection have been validated for this assay.
VARIANT TYPE: LIMIT OF DETECTION:
Single Nucleotide Variants  5% variant allele fraction (20% tumor cellularity preferred)
Small Indels (<15 base pairs) 5-10% variant allele fraction (20% tumor cellularity)
Large Indels (>15 base pairs) Limit of Detection has not been established
Copy Number Amplifications 15% tumor cellularity
Copy Number Losses (CDKN2A and PTEN genes only) 70% tumor cellularity
Inter-genetic and Intra-genetic Fusions 30% tumor cellularity

RECOMMENDATIONS:  This new gene panel is especially recommended for the subpanel tumor types (Lung, Colorectal, Melanoma, Gastrointestinal stromal tumors-GIST).  Other panel testing may be indicated for certian solid tumors (e.g. ovarian, endometrial, breast, prostate), depending on therapeutic considerations (e.g. PARP inhibitors, etc.).
 
Ordering

Ordering Recommendations

Replaces the 50 Gene Cancer Panel, Lung Cancer Panel, Colorectal Panel, Melanoma Panel, and the Gastrointestinal stromal tumors-GIST panel)

Performed

Molecular Diagnostics

Synonyms

  • Lung Cancer (ALK, ROS1, RET)
  • Colorectal Cancer (BRAF, CHEK2, HRAS, KRAS, NRAS, PIK3CA)
  • Melanoma (BRAF, GNA11, GNAQ, HRAS, KIT, NRAS)
  • Gastrointestinal stromal tumors (BRAF, KIT, PDGFRA)
  • GIST
  • Ovarian
  • Endometrial
  • Breast Cancer
  • Prostate Cancer
Result Interpretation
Administrative

CPT Codes

81445
*This test will either require prior authorization or a signed ABN
RPS Interface Information

Test Build Information

OrderCode OrderName ResultCode ResultName CPT
STPP Solid Tumor Precision Panel STPPR Solid Tumor Precision Panel 81445