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US FDA Clears Theranos' Finger Stick and Venous Blood Test System
2 July 2015 - - US-based diagnostics company Theranos, Inc. has received the US Food and Drug Administration's clearance of its test system and test for herpes simplex 1 virus IgG, the company said on Thursday. The FDA's decision provides independent validation of Theranos' patented finger stick and venous blood testing technology and the Theranos System upon which the HSV-1 IgG test is run, as well as the approach that the company has supported for FDA review of laboratory developed tests. The FDA decision involved extensive review of the Theranos System, a highly-automated platform designed to mitigate the human error traditionally associated with the manual processing of samples. According to the company, the FDA clearance includes the use of Theranos' Nanotainer Tubes for tests run by this method, which allow samples to be collected from a few drops of blood from a prick of a patient's finger. The Theranos System, including Theranos' device, analytical software, and Nanotainer Tubes, has been fully validated and cleared for use with this test method. FDA's review process for 510(k) notifications is widely recognized as one of the most rigorous regulatory hurdles in the world for evaluation of the performance, accuracy, and intended use of diagnostic tests. Today's announcement demonstrates that Theranos has met that standard and is an important step in Theranos' HSV-1 studies included matrix comparison studies across sixty-nine Theranos devices. Use of such a large number of devices in the studies is unusual, as such studies are often run on a single or small number of devices.
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