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agency has formalized the "progressive" biomarker qualification process described in the paper and will be releasing a draft guidance detailing the formal steps of the process this July.

When Vectibix received approval from the US Food and Drug Administration in 2006, "Amgen already knew the response rate was low," according to an Amgen official. The company began collecting patient tissue samples from mid-2005 to early 2007, knowing it would "need those samples for a biomarker analysis."

The nonprofit Biden Cancer Initiative is suspending its operations, according to the Associated Press.

Researchers examine how white nationalists handle personal genetic ancestry results that conflict with their racist worldview, the New York Times reports.

NPR speaks with research participants before and after they learn their APOE E4 status, which affects their risk of developing Alzheimer's disease.

In PLOS this week: genetic characterization of Toxoplasma gondii strains, Crimean-Congo Hemorrhagic Fever Virus uncovered in Sudan, and more.