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
