CENBIMO S.L

INTRODUCTION

c-erbB2 is denominated as such as it corresponds to the human homologue of a viral gene that causes leukemia erythroblastosis in birds. This gene was isolated in a neuroblastoma/glioblastoma rat cell colony and for this reason it is also known as HER2-NEU.

This gene codes for a tyrosine kinase receptor situated in the cytoplasmic membrane and for whom the ligand is still unknown .

This protein belongs to a family of receptors whose principle member is EGFr (epidermal growth factor receptor) also known as c-erbB1. This family is made up of four members (c-erbB1, c-erbB2, c-erbB3 and c-erbB4) that share great internal homology. Due to this homology antibodies targeted against this family of proteins can cross react with other members.

It is clinically shown that between 15 and 30% of breast cancers over express the c-erbB2 protein. This over expression implies a worse prognosis for these tumors meaning that they are more aggressive and resistant to Taxol.

As there are therapeutic monoclonal antibodies against this protein is it vital to know if a concrete tumoral case over expresses the c-erbB2 protein or not.

Until now the methods of detection have been based on immunohistochemistry with antibodies targeted against the c-erbB2 protein which generally yield confusing results and the determination of amplification of the gene that codes for thi s product.

Cenbimo has designed a probe for in situ hybridization that detects the transcribed RNA of the c-erbB2 gene.

The detection of messenger RNA for this protein offers multiple advantages as it eliminates the confusing aspects of immunohistochemistry, and on the other hand detects real transcription, as to see genetic amplification by FISH does not guarantee that all amplified genes are transcribing.

Histosonda c-erbB2 consists of 2 fragments of single-stranded DNA with lengths of 672 and 1143 nucleotides that are targeted against expressed sequences of this gene.

The probe incubation period is only 1 hour and as it is a chromogenic hybridisation probe the results can be viewed directly by light microscopy.

INTENDED USE

For use in In Vitro Diagnosis.

Histosonda c-erbB2 is useful for the detection of c-erbB2 RNA and its associated tumors.

WARNINGS AND PRECAUTIONS

Histosonda c-erbB2 has been designed for professional use in In Vitro Diagnosis and must be manipulated by qualified and accordingly trained personnel. In order to obtain the best results, the instructions contained in the manual must be followed. Any change to the indicated temperatures, times or any other step of the process can lead to poor results.

KIT COMPONENTS

The kit includes 20 single test tubes of lyophilized Histosonda c-erbB2.

Histosonda c-erbB2 consists of two segments of single-stranded DNA complementary to expressed RNA, with lengths of 672 and 1143 nucleotides.