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Assay validation and testing

Biomarkers have a central role in patient management.

Geneuity provides numerous tools to detect and characterize biomarkers. Characteristics of a good biomarker assay include target method and analyte performance, specifically sensitivity / prediction, specificity, accuracy, and precision. However, choosing the right biomarker for a clinical study also requires an in-depth knowledge of the disease process that can only be provided by experienced, board certified pathologists and scientists. These specialists provide specimen suitability, clinical utility, interpretation of results, and integration of all pathology data.

Biomarkers support screening, diagnosis, risk stratification, treatment selection, and clinical course monitoring. Geneuity’s capabilities in biomarker assay validation and testing, supported by more than a decade of clinical laboratory experience in personalized medicine, brings a broad mix of technologies, platforms, and capabilities to support drug development.

IHC Markers

Cytokeratins, Epithelial

AE1/AE3, CK5/6, CK7, CK8, 35BH11, CK8/18, CK19, CK20, CAM 5.2, HMW 34BE12, BER EP4, CEA, CDX2, D2-40, GCDFP 15, HEP-Par-1, , Galectin 3, Inhibin, RCC, thyroglobulin, TTF-1, , PLAP

CD Markers

CD1a, CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD15, CD20, CD23, CD30, CD31, CD33, CD34, CD42b, CD43, CD45, CD45 RO, CD56, CD57, CD61, CD68, CD79a, CD99, CD103, CD117, CD138, CD163

Proliferation & prognostics markers

HER2/neu, MLH1/MSH2/MSH6/PMS2, P53, cathepsin D, KI67, WT1, AKT

Other IHC/CISH markers available and custom on request- see menu list

Flow Cytometry Markers

Lymphoid markers

CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD19, CD20, CD23, CD38, CD45, CD56, CD57, sIgkappa, sIglambda, and FMC7

Lymphocyte profile and absolute counts

CD4, CD8, CD3, CD45, CD19, CD56

Myeloid Markers

CD11b, CD13, CD14, CD16, CD33, CD34, CD45, CD117, and HLADR

NK cell markers

CD16, CD56, CD57

Plasma cell markers

CD38, CD45, CD56, CD138, cIg kappa, cIg lambda

Specialty markers

Ber-EP4 Epithelial antigen, CD25, CD30, CD41, CD42b, CD52, CD61, CD10, CD117, EMA Epithelial membrane antigen, Glycophoryin-A, HLA-B27, Nuclear TdT, Intracellular cytokeratin, myeloperoxiodase, CD3, CD79a, CD55, CD59, Ki-1, ZAP-70

Other flow markers on request

Molecular Biomarkers

ABL Kinase Gene Mutation

B‐Cell IgH, IgK; T‐Cell Receptor Gamma Gene Rearrangements

IgVH Mutation Analysis by Sequencing

BCL2 t(14;18) Gene Rearrangement

BCR/ABL,  PML/RARA qPCR

BRAF,  KRAS Mutation

Cystic Fibrosis Mutations by Luminex xTAG 39 Mutation Panel, illumina CF 139 MiSeqDx Panel, illumina CF Clinical Sequencing Panel

P EGFR Exon 18-21

FLT3 Mutation Analysis

GIST mutation

Herpes Simplex Virus Type 1 and 2

Human Papillomavirus Genotyping

JAK2 V617F, JAK2 Exon 12 Mutation Analysis

KIT Mutations, KIT (D816V) mutation

Chlamydia trachomatis, HPV high risk, neisseria gonorrheae, trichomonas vaginalis Aptima Combo2

UGT1A1, CYP2C9 & VKORC1

Other molecular biomarkers available on request

Cytogenetics and Molecular Cytogenetic Markers

G-band, High resolution karyotype analysis

+3 /+ 7 /+17 / del 9p21 bladder cancer

ALK 2p23 anaplastic large cell lymphoma

AML1/ETO t(8,21) AML

API2/MALT1 t(11;18) MALT lymphoma

ATM deletion 11q22.3 chronic lymphocytic leukemia

(BCL1) IGH/CCND1 t(11;14) mantle cell lymphoma

(BCL2) IGH/BCL2 t(14;18) follicular cell lymphoma

BCL6 3q27 B-cell non-Hodgkin lymphoma

BCR/ABL 9q34 (t9;22) philadelphia chromosome

CBFB t(16;16), inv(16) AML

CEP 7 -7/ del 7q31 AML, MDS

C MYC 8q24 Burkitt lymphoma, B-cell large lymphoma

deletion 13q14.3 B-cell chronic lymphocytic leukemia

deletion 20q12 AML, MDS

EGFR/CEP7 (HER1/erb-B1) breast, lung &colon

EGR1 -5/ del 5q31 AML, MDS

EWSR1 22q12 Ewing sarcoma

FIP1L1-PDGFRA (4q12) hypereosinophilia, mast cell

HER2/neu breast cancer

Hyperdiploidy 5, 9, 15, myeloma

IGH/FGFR3 t(4;14) myeloma

IGH 14q32 non Hodgkin lymphoma, myeloma

IGH/MAF t(14;16) myeloma

IGH/MALT1 t(14;18) MALT lymphoma

IGH/MYC, CEP 8 t(8;14) Burkitt lymphoma

MALT1 18q21 MALT Lymphoma

MLL 11q23 AML

MYB deletion 6 chronic lymphocytic leukemia

N-MYC 2p24.1 neuroblastoma, pediatric

Oligodendroglioma del 1p36/del 19q13 glioma

p53 del 17p13.1 various

PML/RARA t(15;17) acute promyelocytic leukemia

PTEN/CEP10 del 10q23

SYT 18q11.2 Synovial sarcoma

TEL/AML1 ES t(12;21) acute lymphoblastic leukemia

X/Y post sex-mismatch transplant

trisomy 3 myeloma

trisomy 4 pediatric ALL

trisomy 6 ALL

trisomy 7 myeloma

trisomy 8 MDS, MPD

trisomy 9 ALL, AML, MDS

trisomy 10 pediatric ALL

trisomy 12 chronic lymphocytic leukemia

Immunoassay Biomarkers

Cytokine & cell signaling detection

Other Immunoassays available on request

Hematopathology, cytopathology, clinical pathology

Morphology, protein expression, distribution, and localization of biomarkers

Embedding & sectioning

Special stains

Immunohistochemical staining

Chromogenic in situ hybridization

Tissue biomarker assays

Leica ST5020 autostainer, Leica BondMax, Leica embedding stations

Ventana Benchmark XT, Ventana Ultra

Miles TissueTek VIP 2000 tissue processor

Aperio Scanscope XT

Biorepository

Biomarker analysis of individual cells

Immunophenotyping, custom panels, cell proliferation, DNA cell cycle analysis, apoptosis

Sample preparation: peripheral blood, bone marrow, fluids, tissue cell suspensions

Multiparameter analysis

Remote review

Biorepository

Navios, Gallios, FC500, Preplus automation

Gene Expression, Genotyping, and Mutation analysis

Cancer and custom gene panels

Small genome De Novo sequencing

Small RNA sequencing

Deep sequencing

Epigenetics

Genetic variants

Targeted resequencing

Single Nucleotide Polymorphism (SNP)

Point mutation detection

Next Generation and Sanger Sequencing

Quantitative PCR

Qualitative PCR

Fragment Analysis / Genotyping

Transcription Mediated Amplification

Illumina® MiSeqDx

ABI 7900, 7500, 3100, 310,

Qiagen® Rotor-Gene Q

Gen-Probe® TIGRIS® / DTS™ , PANTHER®

Oncology and constitutional

Karyotyping

Fluorescence in situ hybridization (FISH)

Comparative genomic hybridization (CGH)

G-band and High Resolution Ch.

FISH probes

Sample preparation: tumor, tissue, bone marrow, amniotic fluid

Metaphase and Interphase

Remote review

Biorepository of pellets

Metafer 4 Imaging System

Multiplex quantitative microarrays

Enzyme immunoassay

Luminex® 100, Alere Triturus® T4

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