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Dx Focus: PrimeraDx Gets Medical Device Manufacturing Certification

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PrimeraDx said this week that it has received certification for ISO 13485:2003, an International Organization for Standardization medical device quality management standard.

BSI Group America performed the review according to ISO 13485:2003 requirements, and focused on PrimeraDx’s design, manufacturing, and distribution of multiplex instrumentation and assays for molecular diagnostics.

Based in Mansfield, Mass., PrimeraDx has developed a technology called scalable target amplification routine, or STAR, which integrates standard endpoint PCR with capillary electrophoresis to simultaneously and quantitatively measure multiple target nucleic acids.

The company has also developed an integrated, benchtop instrument platform called ICEPlex to run STAR-based assays on up to 96 samples simultaneously, including controls, and report on up to 60 targets in each sample in less than four hours (PCR Insider, 7/14/2011).

PrimeraDx currently offers ICEPlex as an open platform to laboratories wishing to develop their own molecular diagnostic tests.

"Achieving ISO 13485:2003 certification is an important milestone and distinguishing differentiator for PrimeraDx. It demonstrates to our customers, collaborators, and companion diagnostic partners that we are dedicated to quality at every level of the organization,” CEO and President Matt McManus said in a statement.

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