Laboratory Test Guide

UW OncoPlex Single Gene

General Information

Lab Name

UW OncoPlex Single Gene

Lab Code

OPG

Epic Name

Order using "UW Genetics and Solid Tumor Test Request"


See tip sheet for more information (internal link).

Description

UW-OncoPlex™ Single Gene (OPG) is intended to test a single gene selected from the UW-OncoPlex™ Panel. See below for the list of offered genes. Complete sequencing of all coding exons is available for most, but not all genes.

Please note that UW-OncoPlex Single Gene (OPG) is intended for solid tumors. For testing related to hematologic malignancies, please order Heme Single Gene by NGS [HCAPSG]. Consultation with a Director can be requested to determine the appropriate testing. Please contact the laboratory at 206-598-6429 for further questions.

This test is designed to detect somatic mutations in cancer and is not designed to detect germline (heritable) mutations.

This test can be used for extended RAS testing (KRAS exon 2, 3, 4 and NRAS exons 2, 3, 4 complete sequencing).

For information on the complete UW-OncoPlex™ Panel, see UW OncoPlex Cancer Gene Panel [OPX].

References

  • Metzker ML. Sequencing technologies - the next generation. Nat Rev Genet 2010, 11:31-46. 19997069
  • Pritchard CC, et al. Validation and implementation of targeted capture and sequencing for the detection of actionable mutation, copy number variation, and gene rearrangement in clinical cancer specimens. J Mol Diagn 2014, 16:56-67. 24189654
  • Salipante SJ, Scroggins SM, Hampel HL, Turner EH, and Pritchard CC. Microsatellite instability detection by next generation sequencing. Clin Chem 2014, 60:1192-9. 24987110
  • Kuo AJ, et al. Validation and implementation of a modular targeted capture assay for the detection of clinically significant molecular oncology alterations. Pract Lab Med. 2020 Feb 3;19:e00153. PMID: 32123717
  • Perrone ME, et al. Validating cell-free DNA from supernatant for molecular diagnostics on cytology specimens. Cancer Cytopathol. 2021 Dec;129(12):956-965. PMID: 34265180

Synonyms

ABCA10, ABCA12, ABCC9, ABL1, ABL2, ABRAXAS1 (FAM175A), ACVR1, AKAP9, AKT1, AKT2, AKT3, ALK, ANGPTL1, ANKRD26, APC, AR, ARAF, ARID1A, ARID1B, ASPH, ASXL1, ASXL2, ATM, ATR, ATRX, AURKA, AURKB, AXIN2, AXL, BABAM1, BAK1, BAP1, BARD1, BCL2, BCL2L11, BCOR, BCORL1, BCR, BICRA (GLTSCR1), BIRC3, BLM, BMPR1A, BRAF, BRCA1, BRCA1&2 Sequencing, BRCA2, BRIP1, BRWD3, BTK, C19MC, CALR, CARD11, CBL, CBLB, CBLC, CCL2, CCND1, CCND2, CCNE1, CD19, CD274, CD33, CD74, CD79B, CDC25A, CDC27, CDH1, CDK12, CDK4, CDK6, CDK8, CDK9, CDKN1A, CDKN1B, CDKN1C, CDKN2A, CDKN2B, CEBPA, CHD1, CHD3, CHD4, CHD8, CHEK1, CHEK2, COG5, CRADD, CREBBP, CRLF2, CRX, CRYBG1, CSF1R, CSF3R, CTCF, CTNNA1, CTNNB1, CUX1, CXCR4, DAXX, DDR2, DDX41, DEPDC5, DICER1, DIS3L2, DNAJB1, DNMT3A, DOCK7, EBF1, EED, EGFR, EGLN1, EIF3E, ELF1, ELP1, EML4, ENG, ENPP3, EP300, EPAS1, EPCAM, EPHA3, EPHA5, EPHB2, EPHB6, EPO, EPOR, ERBB2, ERBB3, ERBB4, ERCC2, ERG, ESR1, ESR2, ETNK1, ETV6, EZH2, FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCL, FANCM, FBXW7, FGFR1, FGFR2, FGFR3, FGFR4, FH, FKBP1A, FLCN, FLT1, FLT3, FLT4, FOLR1, FOXA1, FOXL2, FOXR2, FUBP1, GAB2, GALNT12, GATA1, GATA2, GATA3, GEN1, GFAP, GLI1, GLI2, GLI3, GNA11, GNAQ, GNAS, GNB1, GPC3, GREM1, GRIN2A, GRM3, Gynecological Oncology Pathway, GYNPTH, H3-3A, H3-3B, H3C2 (HIST1H3B), H3C3, HDAC4, HDAC9, HEPACAM, HIF1A, HNF1A, HNRNPU, HOOK3, HOXB13, HRAS, HSPH1, ID3, IDH1, IDH2, IGF1R, IKZF1, IL7R, JAK1, JAK2, JAK3, KCNJ8, KDM2B, KDM6A, KDR, KIF1B, KIF5B, KIT, KLF4, KMT2A, KMT2C, KMT2D, KRAS, KTN1, LYST, LZTR1, MAP2K1, MAP2K2, MAP2K4, MAP7, MAPK1, MAX, MBD4, MC1R, MCL1, MDM2, MDM4, MED12, MEGF6, MEN1, MET, microsatellite instability, MIOS, MITF, MLH1, MLH3, MN1, MPL, MRE11, MSH2, MSH3, MSH6, MSLN, MTAP, MTOR, multigene panel, MUTYH, MYB, MYC, MYCL, MYCN, MYD88, MYOD1, NAB2, NAT2, NBN, next-generation sequencing, NF1, NF2, NKX21, NOP53 (GLTSCR2), NOTCH1, NOTCH2, NOTCH3, NOTCH4, NPM1, NPRL2, NPRL3, NR4A3, NRAS, NRG1, NRP1, NSD1, NT5C2, NTHL1, NTRK1, NTRK2, NTRK3, NUDT15, OFD1, paired tumor panel, PAK1, PALB2, PARP1, PAX5, PBRM1, PDCD1LG2, PDGFB, PDGFRA, PDGFRB, PHF6, PHOX2B, PIGA, PIK3CA, PIK3CB, PIK3R1, PIK3R2, PLCG2, PLK1, PLK2, PLK3, PLK4, PML, PMS2, POLD1, POLE, POT1, PPM1D, PPP1CB, precision medicine panel, precision oncology panel, PRKAR1A, PRPF40B, PRPF8, PRPS1, PTCH1, PTEN, PTPN11, PTPRD, QKI, RAC1, RAD21, RAD50, RAD51B, RAD51C, RAD51D, RAD54L, RAF1, RARA, RASA1, RB1, RECQL, RELA, RET, RHEB, RHOA, RICTOR, RINT1, RIT1, RNF43, ROR1, ROS1, RPL10, RPL31, RPS14, RPS15, RPS20, RPTOR, RRM1, RRM2, RSPO2, RSPO3, RUNX1, SAMD9, SAMD9L, SDHA, SDHAF2, SDHB, SDHC, SDHD, SETBP1, SETD2, SF1, SF3B1, SH2B3, SHH, SIGLEC10, SLC25A13, SLX4, SMAD2, SMAD3, SMAD4, SMARCA4, SMARCB1, SMARCE1, SMC1A, SMC3, SMO, SNAPC3, somatic panel, SOS1, SOS2, SPOP, SPRED1, SPRY4, SRC, SRP72, SRSF2, STAG2, STAT3, STAT5B, STAT6, STK11, STRADA, SUFU, SUZ12, TACC3, TACSTD2, TAFA2 (FAM19A2), TCF3, TERC, TERT, TET1, TET2, TET3, TFE3, TFG, TGFBR2, TLX1, TMEM127, TMPRSS2, TNFAIP3, TNFRSF14, total mutation burden, TP53, TP53BP1, TP73, TRAF7, TRRAP, TSC1, TSC2, TTYH1, tumor panel, TYMS, U2AF1, U2AF2, UBA1, UBR5, USP7, VHL, WRN, WT1, XPO1, XRCC2, YAP1, ZBTB16, ZFTA (C11orf95), ZRSR2

Components

Code Name
OPGGS OncoPlex Single Gene Sequenced Gene
OPGRE OncoPlex Single Gene Result
OPGIN OncoPlex Single Gene Interpretation
OPGCH OncoPlex Single Gene Clinical Information
OPGMT OncoPlex Single Gene Method

Interpretation

Method

Next-generation sequencing.

Genes listed above are sequenced on an Illumina instrument to detect single nucleotide variants, small insertions and deletions, gene amplifications, and selected translocations.

Reference Range

See individual components

Ref. Range Notes

No mutations detected

Guidelines

Ordering & Collection

Specimen Type

Tumor Tissue, Purified DNA, Bone Marrow, Peripheral Blood, accompanied by a PATHOLOGY REPORT for the tested tissue.

Collection

Requirements for Specimen Selection

  • To ensure clinically relevant results, the most recent and/or metastatic sample is preferred to older specimens, provided sufficient tumor is present (see point 2).
  • To ensure detection of all types of mutations there should be at least 10% tumor cells in the tissue area processed for DNA for mutation detection and 20% tumor cells for microsatellite instability evaluation. If there is more than one tissue block, please provide the block that has the greatest percentage of neoplastic nuclei.
  • Tissue samples and pathology reports will be reviewed by directors upon receipt for acceptability prior to testing. Director consultation for tissue selection is available if needed (contact Genetics lab).

Specimen Types

Tissue samples

Send one of the following:

  1. Slides: 1 slide at 4-micron thickness stained with hematoxylin-and-eosin (H&E) AND 10 unstained, non-baked slides at 10-micron thickness (a minimum of 5 unstained slides is acceptable). Unstained slides can be on charged or uncharged slides.
  2. Tissue Blocks: Provide complete formalin-fixed tissue block containing tumor tissue. Tissue block will be returned at completion of testing.
  3. Fresh/frozen tissue: 5 microgram tissue in cell culture medium or frozen tissue stored at -20C. Tumor percentage will not be determined prior to sequencing studies.

NOTE: In order to ensure that enough DNA is obtained, the minimum acceptable tissue area is 10 square millimeters when ten 10-micron slides are supplied (1 cubic millimeter of tissue).

Purified DNA

5 micrograms ANDa reference hematoxylin-and-eosin (H&E) stained slide and pathology report required.

Bone Marrow

1 to 2 mL Bone Marrow in LAVENDER TOP (EDTA) tube

Blood

6 mL blood in LAVENDER TOP (EDTA) tube.

Alternative specimens may be acceptable with approval (contact: 206-598-1149).

For ADD-ON after prior testing, contact Genetics lab.

Unacceptable samples

We cannot accept decalcified samples or tissue samples treated with fixatives other than formalin.

Quantity:

Requested:

  • Tissue: 10 unstained slides (10-micron thickness) plus one H&E-stained slide.
  • Extracted DNA: 5 microgram Bone Marrow: 2 mL
  • Blood: 6 mL

Minimum:

  • Tissue: 5 unstained slides (10-micron thickness) plus one H&E-stained slide.
  • Extracted DNA: 100-250 nanograms Bone Marrow: 1 mL
  • Blood: 3 mL

Forms & Requisitions

Requisition Form and Ordering Instructions

1. Fill out a Genetics Requisition Form

Providers with access to the UW implementation of Epic (i.e., FHCC, HMC, SCCA, UWMC, UWNW) may order this test using the order "UW Genetics and Solid Tumor Test Request." See tip sheet for more information (internal link).

2. Check "UW-OncoPlex™ Cancer Single Gene"

3. Please indicate the gene(s) requested in clinical history space provided.

Genetics Preauthorization Form (preauthorization is only done for providers who are external to the UW system).

Handling Instructions

Attach a copy of the pathology report for the tumor sample being submitted. Include the flow cytometry report for leukemia (e.g., AML) samples.

Quantity

requested: Amounts as noted above
minimum: Amounts as noted above

Processing

Tissue: Hold slides or tissue blocks at room temperature. Outside Laboratory: Ship at room temperature. Stability: unstained slides or tissue blocks stable at room temperature for at least 2 years.

Purified DNA: Refrigerate DNA specimens. Frozen is acceptable.

Blood or Bone Marrow: Refrigerate whole blood and/or bone marrow Unacceptable Conditions: Frozen or clotted specimens

Stability (collection to initiation of testing): Ambient: 2 days; Refrigerated: 7 days

Performance

LIS Dept Code

Genetics (GEN)

Performing Location(s)

UW-MT Genetics

Attention: Genetics Lab
Clinical lab, Room NW220
University of Washington Medical Center
1959 NE Pacific Street
Seattle, WA 98195

Tel: 206-598–6429 M–F (7:30 AM–4:00 PM)
Fax: 206-616-4584
Lab email: cgateam@uw.edu

Tel (EXOME only): 206-543-0459

Faculty
Jillian Buchan, PhD, FACMG
Runjun Kumar, MD, PhD
Regina Kwon, MD, MPH
Christina Lockwood, PhD, DABCC, DABMGG
Abbye McEwen, MD, PhD
Colin Pritchard, MD, PhD
Vera Paulson, MD, PhD
Eric Konnick, MD, MS
He Fang, PhD

Frequency

Typical Turnaround: 3 weeks *Turn around times may vary based on factors such as tissue acquisition and insurance preauthorization.

Available STAT?

No

Billing & Coding

CPT codes

Billing Comments

For additional test/billing information, see following pages:

For pricing information, contact Client Support Services 206-520-4600 or 800-713-5198.

Billing and Insurance Pre-Authorization

We offer insurance pre-authorization services (preauthorization is only done for providers who are external to the UW system).

Email: gpabuw.edu or call 1-855-320-4869 for more information.

Genetics Preauthorization Form

LOINC

51967-8

Interfaced Order Code

UOW5315