Skip to main content
Premium Trial:

Request an Annual Quote

Dx Focus: PrimeraDx Gets Medical Device Manufacturing Certification


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.

The Scan

Not as High as Hoped

The Associated Press says initial results from a trial of CureVac's SARS-CoV-2 vaccine suggests low effectiveness in preventing COVID-19.

Finding Freshwater DNA

A new research project plans to use eDNA sampling to analyze freshwater rivers across the world, the Guardian reports.

Rise in Payments

Kaiser Health News investigates the rise of payments made by medical device companies to surgeons that could be in violation of anti-kickback laws.

Nature Papers Present Ginkgo Biloba Genome Assembly, Collection of Polygenic Indexes, More

In Nature this week: a nearly complete Ginkgo biloba genome assembly, polygenic indexes for dozens of phenotypes, and more.