Theranos secures FDA waiver to take its blood tests out of the lab

Palo Alto-based novel blood test company Theranos was granted a waiver from the FDA allowing the company to offer its first FDA-cleared blood test, its herpes simplex 1 virus IgG (HSV IgG) test, outside of a lab setting. According to the company, it’s the first HSV test to receive the waiver, called a CLIA waiver (CLIA stands […]

Source: mobihealthnews - July 20, 2015 Category: Information Technology Authors: Jonah Comstock Tags: Government/Regulation blood tests CLIA waiver herpes HSV mobile lab tests Theranos Source Type: news