Do you follow Good Lab Procedures? Are your assays validated per FDA guidance?

by | Jun 15, 2020

Yes, we follow Good Laboratory Practices. All of our assays are validated. In particular for plasma/serum total and free (i.e., unbound) concentrations of EPA, DHA, DPA and ARA have been validated per the Guidance for Industry: Bioanalytical Method Evaluation (FDA; May, 2001). These assays (and our red blood cell fatty acid assay) have been and are currently being used in new drug development studies with pharmaceutical sponsors.

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These statements have not been evaluated by the Food and Drug Administration. This test is not intended to diagnose, treat, cure, prevent or mitigate any disease. This site does not offer medical advice, and nothing contained herein is intended to establish a doctor/patient relationship. OmegaQuant, LLC is regulated under the Clinical Laboratory improvement Amendments of 1988 (CLIA) and is qualified to perform high complexity clinical testing. The performance characteristics of this test were determined by OmegaQuant, LLC. It has not been cleared or approved by the U.S. Food and Drug Administration.