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Theranos Isn’t the Only Diagnostics Company Exploiting Regulatory Loopholes

Avoiding pre-market verification is downright easy.

Thirteen of Clubs / Flickr / CC

Theranos isn’t alone in avoiding regulation using an easily exploited loophole — in fact, it’s just one among many.

Pathway Genomics, Admera Health and Strand Life Sciences are diagnostics companies that offer cancer tests that impact people’s health care decisions. None of these companies has published data about its tests in peer-reviewed journals. Nor were any of these companies required to show regulators that their tests worked before they started marketing them to patients and physicians. That’s because each of these companies has been making use of what’s known as the “laboratory developed test” loophole — which makes avoiding pre-market verification downright easy.

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