Whether another company can develop a test for fibrin degradation products has nothing to do with the FDA. The Chinese test is not FDA approved and is supposedly only sold for research.
The test that Gartner proposes to sell will also not be FDA approved. He is using the "home brew" rule where they make their own reagents.
From the statement by Gartner at the bio conference, the test will use a computer algorithm to analyze the results. In the past, the FDA has forced labs selling home brew tests to cease when they contain a computer algorithm. Algorithms are not covered in the home brew rules so if the FDA steps in, they will shut him down.
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