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The McKinsey report "Personalized medicine - the path forward" states that laboratory-developed diagnostics tests (LDTs) are somehow immune to patent challenges.

Quote: "Dx [diagnostics] companies with approved tests cannot protect their IP under the current regulatory system and CLIA governance. Lab service providers can provide substitutes to the FDA-approved Dx tests without fear of patent challenges..." (p. 33 of http://www.mckinsey.com/~/media/mckinsey/dotcom/client_service/Pharma%20and%20Medical%20Products/PMP%20NEW/PDFs/McKinsey%20on%20Personalized%20Medicine%20March%202013.ashx)

Can anyone explain to me whether this is true, and why?

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Welcome to ask patents -- please check our help pages for what kind of questions and how to ask -- patents.stackexchange.com/help –  Soren Aug 21 '14 at 17:14

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