FusionPlex® Pan-Heme Panel [UWMC Clinical Genomics Laboratory]

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General Information

Lab Name
Lab Code
1066
Description

Hematologic malignancies (e.g. leukemias, lymphomas, myelomas, plasma cell neoplasms) frequently have chromosome rearrangements and gene fusions that are important in establishing a diagnosis, predicting prognosis, and guiding therapy choices. The FusionPlex® Pan-Heme Panel is based on next generation sequencing of RNA (cDNA) from bone marrow, leukemic blood, or lymph node tissue to detect somatic oncogenic gene fusions involving any of 72 genes associated with hematological malignancies, without prior knowledge of the fusion partners or the breakpoints of the translocations. This test can also be ordered for a single gene or a subset of 2-10 genes, chosen by the ordering clinician based on clinical and pathological findings. Testing is performed by UWMC - Montlake DLMP Clinical Genomics Laboratory.

Epic Ordering:

  • Test Name: FusionPlex
  • Order Code: LABFUSIONPLEX
  • For orders submitted electronically via Epic, a separate requisition form is not required.
Forms & Requisitions

Outside Providers: CGL Neoplasia Test Request Form

Synonyms
Archer, LABFUSIONPLEX
Components

Interpretation

Method

Total nucleic acid (TNA) is extracted from the sample using standard procedures. First- and second-strand complementary DNA (cDNA) synthesis is performed. A library of DNA fragments is constructed for targeted capture of cDNA from fusion genes using custom designed FusionPlex® Pan-Heme panel and reagent kit (ArcherDX, Boulder, CO). The library is quantitated using quantitative PCR and normalized for next generation sequencing. Paired-end sequencing of the enriched library is performed using Mid Output v2 (Illumina) chemistry on a NextSeq sequencer according to the manufacturer’s recommended protocol (Illumina, Inc. San Diego, CA). FASTQ files with base call and quality information of minimum 4.5 million paired-end sequence reads are processed using Archer Analysis software to annotate gene fusions and variants found within these genes. Human Genome build GRCh37 (hg19) is used. Additional details about this assay are available.

Reference Range
Interferences and Limitations

The FusionPlex® Pan-Heme Panel is used in this test for the sole purpose of identifying gene fusions with both known and unknown fusion partners of cancer-associated gene targets. Not all exons are targeted for each gene transcript in the panel. This assay does not detect gene fusions located outside the targeted gene regions or rearrangements and genomic juxtapositions without producing fusion transcripts. This test also has limited ability to detect low-level tumor content (<10%). The failure to detect an alteration at any locus does not exclude the diagnosis of any of the disorders represented on the targeted panel.

Ordering & Collection

Specimen Type
Bone Core, Bone Marrow, Extracted RNA, Fresh or Frozen Lymph Node, Leukemic Blood, methanol/acetic acid fixed cells, Lymph Node in FFPE
Collection

Leukemic Blood:

  • 1-3 mL in EDTA (lavender top vacutainer). Keep at room temperature.

Bone Marrow:

  • 1-3 mL in EDTA (lavender top vacutainer). Keep at room temperature.

Extracted RNA:

  • 1 microgram (minimum), suspended in water. Store at -20°C. Ship on minimum of 10 lb of dry ice in insulated container by overnight courier. We can only accept RNA isolated in a CLIA-certified laboratory or a laboratory meeting equivalent requirements as determined by the College of American Pathologists and/or the Centers for Medicare and Medicaid Services.

Fresh Frozen Lymph Node:

  • 50-150 mg (0.15-2.0 cm3) fresh tissue snap-frozen. Store at -20°C. Ship on minimum of 10 lb of dry ice in insulated container by overnight courier.

Lymph Node in FFPE:

  • If the specimen is <80% tumor, send 10 unstained section slides at 10 microns each for macro-dissection. Include an H&E slide/image with the tumor portion marked and a copy of corresponding surgical pathology report. Mail slides in a a protected mailing container at room temperature and protect from excessive heat.
  • If the specimen is >80% tumor, send 10 curls at 10 microns each. Put 5 curls in each of two 1.5 mL or 2 mL tubes. Include a copy of corresponding surgical pathology report. Mail at room temperature and protect from excessive heat.

Bone Core: Contact the lab (206-616-4062)

Forms & Requisitions

Outside Providers: CGL Neoplasia Test Request Form

Handling Instructions

Outside Laboratories:

  • Sample collection kits are available upon request. Kits include a biohazard bag with absorbent material, a test requisition, and FedEx shipping materials. Contact the lab at 206.616.4062 to request a kit.
  • A completed request form must accompany all orders.
  • Samples are accepted Monday-Friday.
  • Ship sample to:
    • Clinical Genomics Laboratory
    • University of Washington Health Sciences Building
    • Room H-561
    • 1959 NE Pacific St
    • Seattle, WA 98195
Quantity
Requested: Varies; refer to Collection information.
Minimum: Varies; refer to Collection information.

Processing

Receiving Instructions

Hold samples at room temperature. If sample was frozen when received, keep frozen until pick up.

  • Call UWMC - Montlake DLMP Cytogenetics and Genomics Laboratory at 206.598.4489 for pick up. Cytogenetics is staffed on weekends to accept samples.
  • If no answer or after hours, call 206.598.4488 to leave message.
Misc Sendout

Performance

Lab Department
Frequency
Performed every other week. TAT: 2-3 weeks if insurance pre-authorization is approved.
Available STAT?
Yes
Performing Location(s)
Pathology Clinical Genomics Laboratory
206-598-8684
Other Locations/Notes

Clinical Genomics Laboratory
University of Washington Health Sciences Building
Room H-561
1959 NE Pacific St
Seattle, WA 98195

Ph: (206) 616-4062

Billing & Coding

Billing Comments

CPT code: 81455 (full panel)

CPT code: 81479 (single gene, 2-10 genes)

Prior Insurance Authorization: Contact gpab@uw.edu for details