The test in development will be used to facilitate recruitment of target patient populations and for broad genetic characterization of all trial enrollees which helps to identify those patients most likely to respond to Celgene drug candidates.
Foundation Medicine’s genomic test uses next-generation sequencing (NGS) to analyze routine clinical specimens (i.e., small amounts of paraffin-embedded tumor) for molecular alterations in more than 200 cancer-related genes.
The test will be optimized for clinical-grade analysis of tumor tissues, overcoming multiple complexities (such as purity, ploidy and clonality) inherent to tumor genomes.
Test results will be reported through a secure, interactive website linking genomic data to a structured knowledgebase of relevant, publicly available scientific and medical information.
Patients whose cancers have specific genetic alterations are often very difficult to recruit for clinical trials, so the company also aims to provide information on relevant clinical trials through its website.
The company is working to translate this capability into clinically relevant tests for pathologists and oncologists and expects to obtain CLIA certification as it works to build its cancer diagnostic testing platforms.
Celgen translational medicine head Raj Chopra said the information that Foundation Medicine provides has the potential to make the drug development process which enable them to identify sub-groups of patients in clinical trials who may benefit from their therapies and improve overall outcomes.
