LiquidSEQ™ with Reflex to Solid TumorSEQ™
Test code
CPT code(s)*
Clinical significance
Test resources
Test summary
Details
Includes
If no clinically actionable mutation is detected and at director discretion, then LiquidSEQ may reflex to the Solid TumorSEQ at additional charge (CPT Code(s): 0379U).
Methodology
Next Generation Sequencing (NGS)
Assay category
This test was developed and its performance characteristics determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high complexity clinical laboratory testing.
This test is not available for Wyoming and New York patient testing.
Alternative name(s)
Mutation,FFPE,Pancreatic,Tumor Profiling,CGP,CNV,Large Gene Panel,Colon,500,Comprehensive genomic profiling,Cancer Therapy,Cancer Research,Copy number alteration,Cancer Discovery,Deletion,MSI,Cancer Genomics,Pan-tumor,Circulating Tumor DNA Cells,Pan tumor,Precision medicine,Prostate,SEQ,Tumor Mutation Burden,Single nucleotide variant,SNV,biomarker,Translocation,TSO500,Solid Tumor,Whole gene copy number alteration,Whole gene copy number variation,Therapy Selection,Microsatellite instability,Formalin fixed paraffin embedded,RNA,Splice site variant,Tissue,Gene Rearrangement,Liquid Biopsy,NGS,Melanoma,Oncology,ctDNA,CFDNA,Next Generation Sequencing,STEP500,TMB,Amplification,523,Breast,Fusion,Genomic analysis,Illumina,Insertion,Lung,Copy Number Variant,Molecular,Cell Free DNA
Specimen requirements | |
|---|---|
| Patient preparation | None Specified |
| Preferred specimen(s) | 10 mL whole blood collected in each of two separate Streck cell-free DNA blood collection tubes and tissue collected in a formalin-fixed, paraffin-embedded block |
| Alternative specimen(s) | 10 mL whole blood collected in each of two separate Streck cell-free DNA blood collection tubes and 10 unstained slides of tissue collected in a slide holder |
| Minimum volume | 10 mL whole blood • 1 paraffin block • 5 slides |
| Collection instructions | This test requires two Streck tubes and a tumor specimen. Blood will be collected in office via LiquidSEQ™ kit. Specimens may be shipped separately and at different times. Do not hold blood specimen due to short stability. Do not reject. Blood collection using a straight needle is preferred. All tubes must be filled completely. Gently invert tube at least 8 times immediately after draw. If blood collection is not available in office and providers would like to utilize an in-home draw for blood collection, a mail to home LiquidSEQ kit should be ordered. Simply add test code 13676, "Mobile Phlebotomy Collection, Precision Oncology" with an in-home draw service add test code 18645, "LiquidSEQ Kit", to any order containing LiquidSEQ testing. Please note: If an in-home draw is involved, a collection kit will be shipped to the patient. Please note: The LiquidSEQ kit is not required for PSC draws. A pathology report must accompany paraffin block or slides. Information required in this report includes: Physician identification, specimen identifiers (case and block number), specimen site and type, collection date, collection time, tissue processing used (routine or microwave), cold ischemic time, type of fixative, duration of fixation, pathologic diagnosis, and IHC score, if performed elsewhere. Please note: If Hospital Discharge Date is not populated, outpatient treatment is assumed. If unknown, please enter "NG". Note: If there are multiple blocks for the primary tumor, please send the block with the highest tumor content. Ship room temperature or on an ice pack in summer. For formalin-fixed, paraffin-embedded block and slides a pathology report must be submitted with sample. Do not reject. |
| Transport container | Quest-LiquidSEQ Gen Kit Sterile biohazard plastic bag Slide in Slide Holder |
| Transport temperature | Room temperature |
| Specimen stability | Whole blood Room temperature: 7 days Refrigerated: Unacceptable Frozen: Unacceptable Tissue Room temperature: Acceptable Refrigerated: Acceptable Frozen: Unacceptable Do not reject, send to laboratory for testing assessment |
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.
This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.
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