NEW YORK (GenomeWeb News) – PrimeraDx said on Wednesday that is has received ISO 13485:2003 certification.
The certification is used to create a standardized quality system for designing and manufacturing medical devices. BSI Group America performed the certification according to ISO 13485:2003 requirements and focused on the Mansfield, Mass.-based molecular diagnostic firm's design, manufacturing, and distribution operations.
Privately held PrimeraDx has developed a technology called scalable target amplification routine, or STAR, which integrates standard endpoint PCR with capillary electrophoresis to simultaneously quantitatively measure multiple target nucleic acids. It also has developed an instrument platform called ICEPlex for running STAR-based assays.
Last year, the firm decided to offer its technology as an open platform for labs that want to develop their own molecular tests, according to GenomeWeb Daily News sister publication PCR Insider.