PrimeraDx Gets FDA Clearance for System, C. Difficile Assay | GenomeWeb

NEW YORK (GenomeWeb News) – PrimeraDx said that it has received US Food and Drug Administration 510(k) clearance for its ICEPlex System and ICEPlex C. difficile Assay Kit.

The ICEPlex System is a quantitative multiplex PCR system and can run panels of such diverse analytes as mRNAs, microRNAs, and genomic loci. The platform runs an assay technology called scalable target amplification routine, or STAR, which integrates standard endpoint PCR with capillary electrophoresis to simultaneously quantitatively measure multiple target nucleic acids.

Get the full story

This story is free
for registered users

Registering provides access to this and other free content.

Register now.

Already have an account?
Login Now.

In Science this week: ancient Ethiopian genome indicates greater Eurasian backflow into Africa, sequencing to diagnose cutaneous T cell lymphoma, and more.

The US House of Representatives science committee has passed a bill to require NSF to ensure it only funds projects that are in the national interest.

DuPont teams with genome editing firm Caribou Biosciences for agricultural applications of the technology.

A blogger reviews her experience learning about her gut microbiome by shipping a sample to uBiome.