HISTOGENEX NV
DRIE EIKENSTRAAT 661
B-2650 EDEGEM
BELGIUM
TEL: +32-(0)3-2804815
FAX: +32-(0)3-2804861

Pharma Diagnostics is the linkage of immunohistochemical or FISH analysis to patient management

Pharma Diagnostics including molecular profiling is a growing area in clinical trial testing

HistoGeneX focuses on molecular profiling of tumors

Validated Pharma Diagnostic tests at HistoGeneX are: HER-2/Neu, EGFR, c-kit

New test based on microdissection and RT-PCR are under development

FISH ANALYSIS _________________________________

Fluorescence In Situ Hybridization (FISH) has emerged as a powerful clinical tool for detection of the gene copy number

FISH detects gene amplification, gene translocations and deletions on formalin-fixed or frozen embedded tissue samples
FISH analysis of HER-2/Neu in breast carcinoma
CLINICAL TRIAL TESTING _________________________________

HistoGeneX has experience with studies according GLP regulations

FDA-approved HER-2/Neu and EGFR in clincal trials
Robotic staining equipment for immunohistochemistry as used in HER-2/Neu and EGFR validated assays
HER-2 score 3+ in breast carcinoma
EGFR score 3+
in lung carcinoma
Highly qualified and accreditated histopathologist evaluate tissue samples for clinical trials and Pharma Diagnostics

HistoGeneX works with GLP criteria
Accredidated pathologist evaluating
tissue samples
Data entry and data management by qualified persons