Theranos Wins FDA Nod for Herpes Finger Stick Test
Theranos has gained FDA 510(k) clearance for its herpes simplex 1 virus IgG test system, the Palo Alto, Calif., devicemaker said last week.
The test uses finger stick and venous blood testing technology, the company says.
Unlike conventional tests which are cleared just for venous samples, the system can be used for venous, venous plasma, capillary plasma and capillary whole blood samples, the devicemaker claims.
This is the company’s first FDA clearance. — Jason Scott