Next Generation Sequencing
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.
Cancer Genomics,NGS,Tumor Profiling,500,STEP500,Cancer Therapy,Therapy Selection,Cancer Research,Cancer Discovery
Specimen requirements | |
|---|---|
| Patient preparation | None Specified |
| Preferred specimen(s) | 200 mm2, ≥20% tumor content of tumor tissue collected in a formalin-fixed, paraffin-embedded tissue |
| Alternative specimen(s) | 10 X 10 um (minimum 5 x 10 um) unstained sections of formalin-fixed paraffin-embedded tissue and 1 x 4 um (minimum 1 x 5 um) section with H & E staining, ≥20% tumor content (minimum ≥10% tumor content) • Formalin-fixed paraffin-embedded FNA • 50 uL of 20 ng/uL (minimum 10 uL of 10 ng/uL) extracted DNA |
| Minimum volume | 10 mm2, ≥10% tumor content |
| Collection instructions | For FFPE and slides a pathology report must be submitted with sample. Do not reject. |
| Transport container | Formalin-fixed paraffin-embedded tissue block |
| 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 |
| Reject criteria | Sample with <10% tumor content • Sample less than minimal requirements |
Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.
*The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.
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