These are tests that have not yet been approved by the FDA for general use.
Quote:
The FDA has taken a hands-off approach to LDTs because they once were considered simple and posed little risk to patients. But as technology has advanced, so have LDTs; some are now quite costly and controversial.
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This appears to be an attempt to get around the bureaucratic-controlled FDA which moves at about the speed of a snail.
Read more @
http://www.militarytimes.com/article...TS06/307150070