Five to ten µM sections of tumor-containing tissue placed in a sterile container (>10% tumor content).
If tumor enrichment is required (tissue containing <10% tumor), tissue sections are placed on slides for macrodissection.
One accompanying H&E slide cut after all sections for extraction have been cut.
Unacceptable Conditions
Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives. Tissue containing no tumor.
Storage/Transport Temperature
Room temperature. Ship in cooled container during summer months.
Aid in therapeutic decisions for lung cancer. The test detects single nucleotide changes and small insertions and deletions.
Methodology
Next generation sequencing (NGS) was performed on the Illumina MiSeq platform to identify alterations within the following gene regions based on Genbank accession numbers, version hg19 (GrCH37): BRAF (NM_004333), exon 15; EGFR (NM_005228), exons 18 - 21; ERBB2 (NM_004448), exon 20; KRAS (NM_033360), exons 2 – 4. This NGS method detects single nucleotide changes as well as small insertions and deletions. This assay does not detect chromosomal rearrangements or gene amplifications, and it does not differentiate somatic versus germline mutations. The limit of detection is 5% mutant allele frequency with a minimum coverage of 500 fold. This test was developed and performed and its performance characteristics determined by the BayCare Molecular Laboratory located at 5455 W Waters Ave, Suite 208, Tampa FL 33634. It has not been cleared or approved by the U.S. Food and Drug Administration. 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 or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.
Reported
TAT: 10 - 14 days
Synonyms
Solid Tumor Next Gen sequencing
Reference Interval
No mutations detected
Interpretive Data
See interpretation section of the report.
CPT Codes
81210, 81235, 81275, 81276, 81479
Collection
Patient Preparation
No special patient preparation is necessary
Collect
Five to ten µM sections of tumor-containing tissue placed in a sterile container (>10% tumor content).
If tumor enrichment is required (tissue containing <10% tumor), tissue sections are placed on slides for macrodissection.
One accompanying H&E slide cut after all sections for extraction have been cut.
Unacceptable Conditions
Specimens fixed/processed in alternative fixatives (alcohol, Prefer) or heavy metal fixatives. Tissue containing no tumor.
Storage/Transport Temperature
Room temperature. Ship in cooled container during summer months.
Aid in therapeutic decisions for lung cancer. The test detects single nucleotide changes and small insertions and deletions.
Methodology
Next generation sequencing (NGS) was performed on the Illumina MiSeq platform to identify alterations within the following gene regions based on Genbank accession numbers, version hg19 (GrCH37): BRAF (NM_004333), exon 15; EGFR (NM_005228), exons 18 - 21; ERBB2 (NM_004448), exon 20; KRAS (NM_033360), exons 2 – 4. This NGS method detects single nucleotide changes as well as small insertions and deletions. This assay does not detect chromosomal rearrangements or gene amplifications, and it does not differentiate somatic versus germline mutations. The limit of detection is 5% mutant allele frequency with a minimum coverage of 500 fold. This test was developed and performed and its performance characteristics determined by the BayCare Molecular Laboratory located at 5455 W Waters Ave, Suite 208, Tampa FL 33634. It has not been cleared or approved by the U.S. Food and Drug Administration. 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 or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.
