Pioneering the clinical application of PCR in a GLP setting.
AltheaDx has been a leading provider of PCR-based services since 1998. Co-founded by Drs. Magda Marquet and Francois Ferré, one of the early pioneers in PCR, the company was an early adopter of TaqMan real-time PCR, providing some of the earliest 3rd party data demonstrating its quantitative capabilities. AltheaDx became the first company to use real-time PCR to provide GLP clinical data, specifically for the quantification of gene therapy vectors and their expressed transcripts in tissue.
EXPRESS PATHWAY BIOMARKER AND COMPANION DIAGNOSTIC
Beginning in 2006, AltheaDx launched the Express Pathway biomarker and companion diagnostic development process to fast-track the clinical utilization and commercialization of biomarkers. This turnkey process begins with initial Signature Discovery (e.g., microarray global profiling) which includes acquisition of characterized clinical samples for development and validation of Translational Biomarkers (e.g., PCR testing of targeted gene sets) that are further validated with additional clinical sample acquisition and testing under GLP or CLIA. These biomarker tests are used to increase efficiency and overall success rate of therapeutics in clinical trials and disease monitoring applications. Within the past 18 months, AltheaDx has reached key development agreements for 6 companion diagnostic programs,
4 of which are centered on the XP-PCR technology.
MULTIVARIATE INDEX ASSAYS (IVDMIA)
Additionally, AltheaDx has spent considerable amount of time and resources understanding the regulatory space around multivariate index assays (IVDMIA). The company has developed and validated three diagnostics in pediatric and prostate cancers, and is actively pursuing partnerships to attain FDA clearance. AltheaDx has been involved with FDA on several pre-IDE meetings, and several of these tests are on track for FDA submission in 2012. AltheaDx is the partner of choice for several companion diagnostics currently being used in clinical trials for new cancer therapies.
