Oncoplex Prostate, Circulating Tumor DNA

General Information

Lab Name

Oncoplex Prostate, Circulating Tumor DNA

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)

OPXCTP must be ordered in conjunction with Tumor Test Comparator Sample [OPCOMP] (OncoPlex Comparator) and should be submitted at the time of placing the Molecular Profiling for Genitourinary testing.

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).

Collection

Acceptable Specimen: Also acceptable 1 Streck Cell-Free DNA BCT® tube (mottled black and tan).

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 )

Processing

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

Storage stability:

  • Streck Cell-Free DNA BCT® tube: Ambient, 5 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
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

Frequency

Results in 3 weeks.

Available STAT?

No

Billing & Coding

CPT codes

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

LOINC

51967-8

Interfaced Order Code

UOW6346