July 20, 2015
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 for the Clinical Laboratory Improvement Amendments of 1988).
July 6, 2015
Theranos, the 12-year-old Palo Alto-based company working on a smaller, cheaper, alternative to common lab blood tests, has received its first voluntary FDA 510(k) clearance, for its herpes simplex 1 virus IgG (HSV IgG) test.
Using a (still largely secretive) lab-on-a-chip technology, Theranos is able to run multiple blood tests on just a few drops of blood, whereas traditional labs need to draw...