OPTIMIZED FOR FFPE AND OTHER CLINICALLY RELEVANT TISSUES

A key challenge in the development of gene expression-based assays and companion diagnostics is performing global gene expression profiling on formalin-fixed, paraffin-embedded (FFPE) clinical specimens and translating the resulting predictive signatures to clinical assays. Throughout the development process for the OncoScore Breast assay, we have leveraged AltheaDx's years of proven experience in developing, optimizing and validating real-time qPCR assays for FFPE samples to ensure quality data from sample types that are most practical for clinical research.

FAST-TRACK COMPANION DX DEVELOPMENT PATH

The current regulatory environment virtually mandates that the CDx test be locked down at the start of clinical trials. The OncoScore one test / many endpoint strategy can help to streamline this process with a common starting GMP/ISO reagent platform for multiple drugs; only the algorithm would need to be modified for each new therapy. The resultant OncoScore test can then be integrated with multiple manufacturing partners for IVD manufacturing, global launch and distribution.