Close Menu

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.

US tax agency says 23andMe's genetic health test can be claimed as a medical expense for tax purposes, the Wall Street Journal reports.

The Guardian reports that some UK physicians are calling for increased regulation of direct-to-consumer genetic tests.

Two Democratic lawmakers argue at USA Today that independent science is under attack by the Trump Administration.

In PLOS this week: networks of genes co-expressed in depression, role of minichromosome maintenance genes in lung adenocarcinoma, and more.