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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 have published data about their 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.
Each of these diagnostic tests are positioned to influence crucial health decisions: a positive test result from Pathway Genomics might encourage someone to seek treatment for a disease that will never develop; results from Admera Health and Strand Life Sciences might make someone favor one cancer treatment over another. But what patients might not know is that every single one of these companies was able to start selling their tests without first proving to regulators...
