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"FDA is concerned about the public health consequences of inaccurate results from the PGS device - the main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work," said Alberto Gutierrez, director of the FDA's centre for devices and radiological health, in a letter to the company.

"Patients relying on such tests may begin to self-manage their treatment through dose changes or even abandon certain therapies depending on the outcome of the assessment," he added.

http://www.bbc.co.uk/news/technology-25100878




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