STAR | GenomeWeb

STAR

PrimeraDx, a Mansfield, Mass.-based molecular diagnostics firm, is on track to submit its highly multiplexed PCR-based testing system and associated assay for Clostridium difficile to the US Food and Drug Administration this quarter, CEO Matt McManus said recently.

PrimeraDx said this week that its ICEPlex quantitative multiplex PCR system and accompanying Clostridium difficile detection assay have received CE marking.

Molecular diagnostics developer PrimeraDx is making headway in its efforts to reach out to pharmaceutical companies to spur adoption of its highly multiplexed, quantitative PCR-based DNA testing platform for companion diagnostic development, according to a company official.

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

Thus far, the company has inked collaborative agreements with laboratories at the MD Anderson Cancer Center and Dartmouth Medical College to develop various multi-marker oncology assays; and is pursuing partnerships with pharmaceutical companies to explore using the platform in companion diagnostic development.

Harold Varmus, a former NIH director, says that proposed reductions to the agency's budget are worrisome.

The Genome 10K project is to sequence about 10,000 vertebrate genomes, including ones of endangered species, Digital Trends reports.

The new Coalition to Save NIH Funding aims to educate lawmakers and the public on the significance of biomedical research.

In PLOS this week: analysis of viral sequences from human blood samples, gut microbiomes of heart failure patients, and more.