PSTC

Led by the Critical Path Institute and Roche's Ventana Medical Systems, the project aims to fill a gap in the current biomarker pipeline, and will hopefully speed the progression of proposed biomarkers through the FDA's qualification pipeline, said a C-Path official.

The decision is the first ever biomarker qualification decision by Japan's PMDA and means that the biomarkers are now qualified at the same level by all of the regulatory agencies comprising the ICH, including FDA and EMEA.

An FDA official said that the agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.

Mice in New York harbor both antibiotic-resistant bacteria and novel viruses, according to a new analysis of their fecal microbiomes.

Human Heredity and Health in Africa Initiative has issued guidelines for genomic research in the region, according to Nature News.

The Associated Press reports that an ethicist predicts that prenatal diagnosis and other advances will lead to more choices being available to prospective parents.

In Genome Biology this week: approach to analyze alternative polyadenylation, algorithm to predict transcriptomic structural variations, and more.