Wednesday, February 17, 2021 2:31:43 PM
Diagnostic test doesn't seem to need FDA approval since it's not a medical device:
https://www.ndx-discern.com/discern/
"Disclaimer: This test was developed and its performance characteristics were determined by the Rockefeller Neuroscience Institute and SYNAPS Dx. It has not been cleared or approved by the US Food and Drug Administration. The FDA does not require this test to go through premarket FDA review. It should not be regarded as investigational or for research. This test should be interpreted in context with other clinical findings. The SYNAPS Dx’s laboratory is certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. Although these tests are highly accurate, rare diagnostic errors may occur. Possible diagnostic errors include sample mix-up, erroneous specimen identification, technical errors and clerical errors. The report from SYNAPS Dx does not represent medical advice. Any questions, suggestions, or concerns regarding interpretation of results should be forwarded to a physician skilled in interpretation of the relevant medical literature."
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