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LUNGSEQ Panel
Test Code36915
CPT Codes
81445
Preferred Specimen
Paraffin-embedded tissue accompanied by a circled H&E slide indicating the area to be examined collected in a sterile biohazard plastic bag or
10 formalin-fixed paraffin-embedded tissue slides and H&E slide collected in a slide holder
10 formalin-fixed paraffin-embedded tissue slides and H&E slide collected in a slide holder
Instructions
Specimen to be tested must contain a minimum of 10% tumor
Transport Temperature
Room temperature
Specimen Stability
Room temperature: Indefinite
Refrigerated: Indefinite
Frozen: Unacceptable
Refrigerated: Indefinite
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Decalcified tissue specimen
Methodology
Next Generation Sequencing
FDA Status
This test was developed and its performance characteristics determined by med fusion. 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
Sets up 2 days a week.
Clinical Significance
This test is intended to be used for the molecular genotyping of tumors from patients with Non-Small-Cell Lung Cancer in order to help prioritize treatment.