DX PLATFORMS VALIDATION
Molecular companion diagnostics tests provide essential information that enables doctors to identify those patients that are most likely to benefit from a treatment. Such tools also allow doctors to monitor response, detect resistance to therapy and switch treatment when necessary, increasing drug efficacy and subsequently, the life expectancy of the patient.
Companion diagnostics must be highly accurate in order to ensure that decisions based on generated results are optimal. Under this context, Pangaea Lab has been selected as external laboratory for the validation of different molecular diagnostic tests.
- Providing services to RMS (Roche Molecular Systems) for the validation of the COBAS EGFR kit, which led to the FDA approval of this technology as “companion kit” for Tarceva (erlotinib) in EGFR+ lung cancer patients (2013)
- Validation of efficacy prior commercialization of different diagnostic kits: