PrimeraDx

NEW YORK (GenomeWeb) — As part of its quest to become a catch-all provider of tools and technologies for molecular diagnostic and especially companion diagnostic development, Qiagen has added another molecular analysis platform to its portfolio.

This article has been updated from a previous version as Qiagen clarified an earlier statement regarding its acquisition of PrimeraDx.

PrimeraDx said this week that the US Food and Drug Administration has granted 510(k) clearance for its ICEPlex C. difficile assay kit and ICEPlex molecular diagnostics system.

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.

Privately held molecular diagnostics firm PrimeraDx has been forced to downsize as it undergoes a restructuring and attempts to put together a new round of financing to fund future activities, PCR Insider has learned.

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.

This article has been updated from a previous version to include comments from PrimeraDx.

NEW YORK (GenomeWeb News) – PrimeraDx today announced a deal with Quest Diagnostics to co-develop molecular diagnostic products and services.
The focus of the non-exclusive deal is to support drug developers in the clinical development of targeted therapeutics.

PrimeraDx has been awarded US Patent No. 8,321,140, "Quantification of nucleic acid molecules using multiplex PCR."
Kyle Hart, Vladimir Dancik, Michael Bristol, Patrick Wells, Elizabeth Garcia, Vladimir Slepnev, and John Unger are named as inventors.

NEW YORK (GenomeWeb News) – PrimeraDx has landed a grant from the National Cancer Institute to develop a gene expression profiling assay that can rapidly detect diffuse large B-Cell lymphoma (DLBCL) subgroups, making it easier to diagnose the disease, select treatment options, and predict the lik

Pages

Sometimes genetic tests give inconclusive results and provide little reassurance to patients, the Associated Press reports.

Vox wonders whether gene-editing crops will be viewed similarly as genetically modified organisms of if people will give them a try.

In Science this week: research regulation and reporting requirement reform, and more.

With H3Africa, Charles Rotimi has been working to bolster the representation of African participants and African researchers in genomics, Newsweek reports.