Oncoplex Prostate, Circulating Tumor DNA

General Information

Lab Name

Lab Code

OPXCTP

Epic Name

Oncoplex Prostate, Circulating Tumor DNA

Description

UW-OncoPlex™ CT is a multiplexed gene sequencing panel that detects mutations in plasma cell free DNA in >350 cancer-related genes (listed in the methods below). The panel includes genes related to cancer treatment, prognosis, and diagnosis. The test uses next-generation "deep" sequencing to detect most classes of mutations, including single nucleotide variants, small insertions and deletions (indels), gene amplifications, and selected gene-fusions.

This test is currently only available for patients with metastatic prostate cancer meeting the following criteria:

1) PSA>10 OR

2) Variant histology (small cell or similar)

Synonyms

ABCA10, ABCA12, ABCC9, ABL1, ABL2, ABRAXAS1 (FAM175A), ACTB, ACTG1, ACVR1, AIP, AKAP9, AKT1, AKT2, AKT3, ALK, AMER1, 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, BUB1B, C19MC, CALR, CARD11, CBL, CBLB, CBLC, CCL2, CCND1, CCND2, CCNE1, CCR4, CD19, CD22, CD274, CD33, CD74, CD79B, CDC25A, CDC27, CDC73, 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, CYSLTR2, DAXX, DDR2, DDX41, DEPDC5, DICER1, DIS3L2, DKC1, DNAJB1, DNMT3A, DOCK7, EBF1, EED, EGFR, EGLN1, EIF3E, EIF6, ELANE, ELF1, ELOC, ELP1, EML4, ENG, ENPP3, EP300, EPAS1, EPCAM, EPHA3, EPHA5, EPHB2, EPHB4, EPHB6, EPO, EPOR, ERBB2, ERBB3, ERBB4, ERCC2, ERCC6L2, ERG, ESR1, ESR2, ETNK1, ETV6, EXT1, EXT2, 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, HSD3B1, HSPH1, ID3, IDH1, IDH2, IGF1R, IKZF1, IKZF2, IL7R, INO80, IRF8, JAK1, JAK2, JAK3, KAT6B, KCNJ8, KDM2B, KDM3B, KDM6A, KDR, KEAP1, KIF1B, KIF5B, KIT, KLF4, KMT2A, KMT2C, KMT2D, KRAS, KTN1, LYST, LZTR1, MAP2K1, MAP2K2, MAP2K4, MAP3K8, MAP7, MAPK1, MAX, MBD4, MC1R, MCL1, MDM2, MDM4, MECOM, 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, NKX2-1, NOP53 (GLTSCR2), NOTCH1, NOTCH2, NOTCH3, NOTCH4, NPM1, NPRL2, NPRL3, NR4A3, NRAS, NRG1, NRP1, NSD1, NT5C2, NTHL1, NTRK1, NTRK2, NTRK3, NUDT15, NYNRIN, OFD1, paired tumor panel, PAK1, PALB2, PARP1, PAX5, PBRM1, PDCD1LG2, PDGFB, PDGFRA, PDGFRB, PHF6, PHOX2B, PIGA, PIK3CA, PIK3CB, PIK3R1, PIK3R2, PLCB4, PLCG2, PLK1, PLK2, PLK3, PLK4, PML, PMS2, POLD1, POLE, POLQ, POLR2A, POT1, PPM1D, PPP1CB, precision medicine panel, precision oncology panel, PREX2, PRKAR1A, PRPF40B, PRPF8, PRPS1, PTCH1, PTEN, PTPN11, PTPRD, QKI, RAC1, RAD21, RAD50, RAD51B, RAD51C, RAD51D, RAD54L, RAF1, RARA, RASA1, RASA2, RB1, RECQL, RECQL4, RELA, REST, RET, RHEB, RHOA, RICTOR, RINT1, RIT1, RNF43, ROR1, ROS1, RPL10, RPL31, RPS14, RPS15, RPS19, RPS20, RPTOR, RRAS, RRAS2, RRM1, RRM2, RSPO2, RSPO3, RTEL1, RUNX1, SAMD9, SAMD9L, SBDS, SDHA, SDHAF2, SDHB, SDHC, SDHD, SETBP1, SETD2, SF1, SF3B1, SH2B3, SHH, SHOC2, 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, TFEB, TFG, TGFBR2, TINF2, TLX1, TMEM127, TMPRSS2, TNFAIP3, TNFRSF14, total mutation burden, TP53, TP53BP1, TP73, TRAF7, TRIM28, TRIM37, TRRAP, TSC1, TSC2, TTYH1, tumor panel, TYK2, TYMS, U2AF1, U2AF2, UBA1, UBR5, UBTF, USP7, USP9X, VHL, WRN, WT1, XPO1, XRCC2, YAP1, ZBTB16, ZBTB7A, ZFTA (c11orf95), ZRSR2

Components

Code	Name
OPPPRE	Oncoplex Prostate, ctDNA, Result
OPPIN	Oncoplex Prostate, ctDNA, Interpretation
OPPCI	Oncoplex Prostate, ctDNA, Clinical Information
OPPMT	Oncoplex Prostate, ctDNA, Method
OPPGS	Oncoplex Prostate, ctDNA, Genes Sequenced
OPPCDI	Oncoplex Prostate, ctDNA, Director

Interpretation

Method: Next-generation sequencing.

For OPXCT:

Gene Fusions and Rearrangements Detected*** (assay version 9)

ALK, BRAF, C11orf95, CD74, DNAJB1, EGFR, EIF3E::RSPO2, EML4, FGFR1, FGFR2, FGFR3, KMT2A, MET, NTRK1, NTRK2, ETV6::NTRK3, RAF1, RET, ROS1, RSPO3, TMPRSS2 (select fusions only), YAP1

***Some fusions involving the genes listed above are not detectable by this method

Microsatellite Instability and Tumor Mutation Burden Analysis

Microsatellite instability (MSI) status and TMB number is reported in selected cases with adequate tumor content. MSI is detected using methods described in Salipante et al. 2014. TMB-HIGH = >10 mutations/Mb and TMB is reported as the number of coding somatic variants per megabase of the OPX coding region (1,205 kilobases).
Reference Range: See individual components

Ordering & Collection

Specimen Type: 20 mL whole blood in two (2) Streck Cell-Free DNA BCT® tubes (mottled black and tan) AND one lavender EDTA top or yellow ACD or blue sodium citrate tube.
Collection: Acceptable Specimen: Also acceptable 1 Streck Cell-Free DNA BCT® tube (mottled black and tan) AND 1 lavender EDTA/yellow ACD/blue sodium citrate top tube for short draws

Note: Submitting only one Streck Cell-Free DNA BCT® tube (mottled black and tan) and one lavender tube constitutes a short draw. As a result, any required repeat or additional testing may not be possible and could lead to test cancellation.
Quantity: Requested: Entire sample. Requested: 20 mL whole blood
Minimum: Minimum: 7 mL whole blood (1 streck tube AND 1 lavender EDTA/yellow ACD/blue sodium citrate top tube

Processing

Receiving Instructions

Do not send samples via pneumatic tube system. Samples collected in Streck tubes must be walked to the laboratory.

Stability:

Streck Cell-Free DNA BCT® tube: Ambient, 5 days
Lavender top tube: Refrigerated

Misc Sendout

Performance

Lab Department

Genetics(GEN)

Frequency

Results in 3 weeks.

Available STAT?

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 Candace Myers, PhD Colin Pritchard, MD, PhD Vera Paulson, MD, PhD Eric Konnick, MD, MS He Fang, PhD Ghayda Mirza, MD Kristyn Galbraith, MD Annie Garcia, MD Karen Chisholm, MD, PhD

Billing & Coding

LOINC: 51967-8
Interfaced Order Code: UOW6346
Billing Comments: For additional test/billing information, see following page: Oncoplex Prostate, Circulating Tumor DNA Billing.

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

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

Email: gpab@uw.edu or call 1-855-320-4869 for more information.

Genetics Preauthorization Form