PSTC | GenomeWeb

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agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.

In PNAS this week: genes involved in histone deacetylation in Arabidopsis, effects of pathogenic presenilin-1 mutations, and more.

After a study finds DNA from antibiotic-resistant bacteria in Beijing smog, residents there worry, according to the New York Times.

Canada begins its search for a chief government science advisor, Nature News reports.

A company is using facial recognition tools to identify genetic disorders from pictures, Technology Review reports.