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agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.

A phylogenetic analysis indicates two venomous Australian spiders are more closely related than thought, the International Business Times reports.

Technology Review reports that 2017 was the year of consumer genetic testing and that it could spur new analysis companies.

In Science this week: CRISPR-based approach for recording cellular events, and more.

A new company says it will analyze customers' genes to find them a suitable date, though Smithsonian magazine says the science behind it might be shaky.