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LiquidSEQ™ with Reflex to Solid TumorSEQ™
Test Code14343
CPT Codes
81464<br><strong>This test is not available for Wyoming and New York patient testing.</strong>
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).
Preferred Specimen
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
Minimum Volume
10 mL whole blood • 1 paraffin block • 5 slides
Other Acceptable Specimens
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
Instructions
This test requires two Streck tubes and a tumor specimen.
Blood will be collected in office via Quest-LiquidSEQ Gen Kit. Specimens may be shipped separately and at different times. Do not hold blood specimen due to short stability. Do not reject.
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".
Please note: This test can be ordered prior to the patients planned surgery. Please enter the planned Tissue Collection Date, and planned Specimen Location. For all other fields related to tissue procurement please enter "NG".
Blood collection using a straight needle is preferred. Use kit only. All tubes must be filled completely. Gently invert tube at least 8 times immediately after draw.
Note: If there are multiple blocks for the primary tumor, please send the block with the highest tumor content.
Ship room temperature or on ice pack in summer.
For formalin-fixed, paraffin-embedded block and slides a pathology report must be submitted with sample. Do not reject.
Blood will be collected in office via Quest-LiquidSEQ Gen Kit. Specimens may be shipped separately and at different times. Do not hold blood specimen due to short stability. Do not reject.
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".
Please note: This test can be ordered prior to the patients planned surgery. Please enter the planned Tissue Collection Date, and planned Specimen Location. For all other fields related to tissue procurement please enter "NG".
Blood collection using a straight needle is preferred. Use kit only. All tubes must be filled completely. Gently invert tube at least 8 times immediately after draw.
Note: If there are multiple blocks for the primary tumor, please send the block with the highest tumor content.
Ship room temperature or on ice pack in summer.
For formalin-fixed, paraffin-embedded block and slides a pathology report must be submitted with sample. Do not reject.
Transport Temperature
Room temperature
Specimen Stability
Whole blood
Room temperature: 7 days
Refrigerated: Unacceptable
Frozen: Unacceptable
Tissue
Room temperature: Acceptable
Refrigerated: Acceptable
Frozen: Unacceptable
Room temperature: 7 days
Refrigerated: Unacceptable
Frozen: Unacceptable
Tissue
Room temperature: Acceptable
Refrigerated: Acceptable
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Do not reject, send to laboratory for testing assessment
Methodology
Next Generation Sequencing (NGS)
FDA Status
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.
Setup Schedule
Set up: Sun, Tues, Thurs; Report available: 7-10 days
Reference Range
See Laboratory Report
Clinical Significance
Plasma-based ctDNA tumor profiling with reflex to tissue-based tumor profiling may be clinically useful in specific circumstances such as when expedited biomarker testing is needed to inform patient care or when tissue adequacy or availability may be limited.
The 523-gene comprehensive genomic profiling panel is intended to help oncologists deliver precision medicine by providing personalized genomic analysis of a patient's tumor. This comprehensive panel offers the opportunity for a broader scope of genomic information compared to single gene tests or smaller panels. For example, it may be useful for patients with limited or ill-defined treatment options and for those considering clinical trials. The test is designed to detect single nucleotide variants (SNVs) and small insertions/deletions, as well as whole-gene copy number alterations and translocations in a select group of genes. Microsatellite instability (MSI) and tumor mutation burden (TMB) are also evaluated.
The 523-gene comprehensive genomic profiling panel is intended to help oncologists deliver precision medicine by providing personalized genomic analysis of a patient's tumor. This comprehensive panel offers the opportunity for a broader scope of genomic information compared to single gene tests or smaller panels. For example, it may be useful for patients with limited or ill-defined treatment options and for those considering clinical trials. The test is designed to detect single nucleotide variants (SNVs) and small insertions/deletions, as well as whole-gene copy number alterations and translocations in a select group of genes. Microsatellite instability (MSI) and tumor mutation burden (TMB) are also evaluated.
