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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.

Consulting company McKinsey says diagnostics companies will have to combine genomic data analysis, electronic medical records, effective reimbursement strategies, and regulatory compliance in order to win.

A new report has found that researchers in Africa are still heavily dependent on funding from organizations in the US, Europe, and China, Nature News says.

An article in The Atlantic argues that the progress being made in science isn't keeping pace with the money and time being spent on research.

In Science this week: a CRISPR screen identifies sideroflexin 1 as a requisite component of one-carbon metabolism, and more.