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Solid Tumor Expanded Panel
Test Code93233
CPT Codes
0379U
Preferred Specimen
200 mm2, ≥20% tumor content of tumor tissue collected in a formalin-fixed, paraffin-embedded tissue
Minimum Volume
10 mm2, ≥10% tumor content
Other Acceptable Specimens
10 x 10 um unstained sections of formalin-fixed paraffin-embedded tissue and 1 x 4 um section with H & E staining ≥20% tumor content • 5 x 10 um section of unstained sections of formalin-fixed paraffin-embedded tissue and 1 x 5 um section with H & E staining, ≥10% tumor content. Clients should be notified to send more sections if possible.
Formalin-fixed paraffin-embedded FNA, ≥20% tumor content or ≥10% tumor content. Extracted DNA, 50 uL of 20 ng/uL or 10 uL of 10 ng/uL or 50 ng total in <30 uL of Extracted DNA from a CLIA approved lab. If only extracted DNA is available, fusion results will not be reported.
Formalin-fixed paraffin-embedded FNA, ≥20% tumor content or ≥10% tumor content. Extracted DNA, 50 uL of 20 ng/uL or 10 uL of 10 ng/uL or 50 ng total in <30 uL of Extracted DNA from a CLIA approved lab. If only extracted DNA is available, fusion results will not be reported.
Instructions
For FFPE and slides a pathology report must be submitted with sample. Do not reject.
Transport Temperature
Room temperature
Specimen Stability
Tumor tissue
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Unstained sections of FFPE tissue and H & E stained section
Room temperature: 28 days
Refrigerated: 5 years
Frozen: Unacceptable
FFPE FNA
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Extracted DNA
Room temperature: 14 days
Refrigerated: 90 days
Frozen: 5 years
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Unstained sections of FFPE tissue and H & E stained section
Room temperature: 28 days
Refrigerated: 5 years
Frozen: Unacceptable
FFPE FNA
Room temperature: 5 years
Refrigerated: 5 years
Frozen: Unacceptable
Extracted DNA
Room temperature: 14 days
Refrigerated: 90 days
Frozen: 5 years
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Sample with <10% tumor content • Sample less than minimal requirements
Methodology
Next Generation Sequencing
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Tues, Thurs; Report available: 14 days
Clinical Significance
Solid Tumor Genomics from Quest Advanced Diagnostics - Precision medicine is an emerging approach for disease prevention and treatment that takes individual variability into account. This next-generation sequencing (NGS) panel along with the computational resources and tools that process and analyze the data, allows the characterization of individual patients and tumor types. Guidelines exist for using results from many of these genes for selection of FDA approved therapies. This NGS panel can accurately and sensitively sequence more target genes with less DNA, with reduced cost, time and labor as compared with more limited sequencing methods and the physician can become aware of alternative treatments available to the patient based on presence of mutations in other genes the physicians might not have considered. Microsatellite instability (MSI) and tumor mutation burden (TMB) are also included. The panel allows the generation of diverse data obtained and analyzed in real-time, enabling enrollment in specific clinical trials, and adaptation of treatment strategies.
