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Tag Archives: Theranos—

Theranos, Holmes sanctioned by CMS

July 8, 2016—Theranos has received notice from the Centers for Medicare & Medicaid Services regarding the imposition of sanctions arising from the 2015 survey of its Newark, Calif., laboratory. The sanctions, which do not immediately take effect, include: Revocation of the laboratory’s CLIA certificate which, as dictated by the regulations, includes a prohibition on owners and operators of the lab ...

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Theranos lands CLIA waiver for HSV-1 test

July 17, 2015—Theranos announced that its test and its test system for the herpes simplex 1 virus IgG has received a Clinical Laboratory Improvement Amendments waiver from the FDA, permitting its use outside traditional, CLIA-certified clinical laboratories. The waiver comes on the heels of the agency’s granting 510(k) clearance to Theranos’ HSV-1 test and system. Theranos said the decision represents ...

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FDA clears Theranos’ fingerstick HSV-1 test

July 8, 2015—Theranos has received the FDA’s clearance of its test system and test for herpes simplex 1 virus IgG. The company said the FDA’s decision provides independent validation of its patented fingerstick and venous blood-testing technology and the system upon which the HSV-1 IgG test is run, as well as the approach that the company has supported for FDA ...

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