Lymph node status is one of the most important prognostic factors in many cancers and a key criterion for surgical and therapeutic decisions. Great importance is therefore attached to the reliable and accurate analysis of the lymph node tissue for detection of metastases.
OSNA® – One Step Nucleic Acid Amplification – is a highly automated molecular assay. The reaction procedure is based on specific isothermal technology to amplify nucleic acid (RT-LAMP) and allows the detection of Cytokeratin 19 (CK19) mRNA expression. CK19 is an epithelial cell marker and is not normally present in lymph node tissue. The expression rate of CK19 mRNA correlates with the size of the metastatic foci. The benefits of using OSNA® include:
- Prompt availability of results
- Automated and standardised test procedure
- High levels of sensitivity and specificity
- The entire lymph node can be analysed
- Simple test performance even without molecular biological expertise
OSNA® is CE-certified and complies with the requirements of Directive 98/79/EC for in-vitro diagnostic medical devices and is thus approved for use in diagnostics.