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agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.

The Chan Zuckerberg Initiative is investing in Cold Spring Harbor Laboratory's BioRxiv.

A study appearing in PLOS One finds that shortened consent forms don't affect clinical trial participants' understanding of the study.

The National Security Agency monitored signal intelligence for signs of "nefarious" genetic engineering projects, Gizmodo reports.

In Nature this week: barley genome sequenced, method for genotyping and phasing short tandem repeats, and more.