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image: Theranos in Hot Water with CMS

Theranos in Hot Water with CMS

By | January 29, 2016

The blood-testing company must respond to the US Centers for Medicare and Medicaid Services’ allegations of substandard conditions at one of its labs.

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image: Diagnostics Group Refutes FDA’s Concerns

Diagnostics Group Refutes FDA’s Concerns

By | December 17, 2015

The Association for Molecular Pathology finds fault in the agency’s report on safety issues associated with certain lab tests.

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image: FDA: Lab Tests Can Cause Harm

FDA: Lab Tests Can Cause Harm

By | November 17, 2015

The US Food and Drug Administration cites cases in which laboratory-developed tests “may have caused or have caused actual harm to patients.”

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image: FDA Gets Into the Lab Test Game

FDA Gets Into the Lab Test Game

By | August 4, 2014

So-called laboratory-developed tests will eventually face regulations similar to those that currently govern diagnostic tests or kits that are sold to hospitals.

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