It is critical for companion diagnostic device makers to validate their assays under GLP or GMP for regulatory submissions. Avance Biosciences offers a series of “Gold Standard” methods that are often required by regulatory agencies for diagnostic test validation or assay validation.
Sanger sequencing is utilized as the “Gold Standard” to validate nucleic acid based diagnostic tools/devices for Premarket Approval (PMA) or 510K clearances. Avance Biosciences’ DNA Sequencing services are performed in compliance with cGMP and GLP enacted by the US, European, Japanese, and other international regulatory agencies.
Avance Bioscience team has more than two decades of experience supporting validation of diagnostic tests. Our team successfully helped many pharmaceutical and diagnostic companies to validate their assays based on ICH guidelines.