Tell the FDA to Stop Harassing LDT Innovators!

For the past few weeks, the laboratory-developed testing (LDT) startup company Theranos has been under close FDA scrutiny for its various testing technologies, and it recently was the subject of an FDA inspection. The FDA also told Theranos that it would have to resubmit data for a number of proprietary blood tests they are seeking approval for—that the previously submitted data was insufficient to determine the tests’ accuracy. 

Although the FDA does not have the authority to regulate laboratory-developed testing, Theranos has agreed to comply with all of the FDA’s requests, but the mainstream media’s mudslinging  has caused famous people like Henry Kissinger and George Schultz to leave Theranos’s board.

Tell the FDA to stop harassing Theranos, as well as the personal genetic testing company 23andMe, and other innovators in the LDT field.

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  • Stephen Ostroff

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Stop Harassing LDT Innovators

Dear [Decision Maker],

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