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agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.

CNBC reports that Amazon invested in the startup Grail as it sees an opportunity for its cloud computing company in genomics.

Researchers are working on re-making the yeast genome from scratch, according to the Associated Press.

Lawrence Krauss writes at Slate that science is needed for good public policy and should not be ignored.

In Cell this week: functional profiling of Plasmodium genome, a self-inactivating rabies virus, and more.