Biomarker Assay and Validation

Biomarker Assay Development and Biomarker Validation for Pharmaceutical Companies

   
2009, Október 12. 10:50

We validate biomarkers, develop diagnostic assays on clinical tissue samples (fresh tissue, formalin fixed paraffin embeded tissue, cytology smears) and provide central molecular diagnostic services for biomarker trials. We have already validated assays for Roche Applied Sciences and tested clinical samples for Roche (Pharma), AstraZeneca, Merck and Amgen.

 

Reference:


KPS has performed EGFR and KRAS gene mutation testing in non-small cell lung cancer patients in early-access and post-marketing biomarker clinical trials of erlotinib (Roche) and gefitinib (AstraZeneca). In this study, we were among the first to show that the predictive value of EGFR activating mutations are independent from copy number gain and immunohystochemistry. Further, our result molecular diagnostic test reached the 100% clinical predictive value .
 

KPS served as a reference laboratory of a KRAS mutation testing validation trial in colon cancer for Amgen, and a similar project is underway in lung cancer to validate EGFR mutation testing for AstraZeneca.


KPS has been an continous partner of Roche Applied Sciences in new assay development and validation. For example, amplification of mRNA.

 

Pinter F, Kopper L, Schwab R, Petak I: Epidermal growth factor receptor (EGFR) high gene copy number and activating mutations in lung adenocarcinomas are not consistently accompanied by positivity for EGFR protein by standard immunohistochemistry.J Mol Diagn. 2008 Mar;10(2):160-8.

Jori B, Pinter F, Lorincz A, Micsik T, Petak I: Light Cycler® RNA Pre-Amplification Kit is a Highly Effective Tool of Gene Expression Studies in Scarce and Fragmented RNA Samples, Roche Biochemica No. 4 2008



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