Enable Biosciences operates a high-complexity CLIA-certified clinical laboratory in South San Francisco.
|CA State ID:||CDF-00354427|
|Lab Director:||Lynette Sawyer, DPH|
Enable Biosciences Inc. uses Antibody Detection by Agglutination PCR (ADAP), a proprietary and highly validated immunoassay technology. Each sample is analyzed for three antibodies (GAD65, IA2, and INS) at our lab in South San Francisco using a custom Enable-Hamilton Assay-Ready workstation and a Bio-Rad CFX Quantitative PCR analyzer. This original screen is set at three standard deviations above the average as determined through the analysis of healthy negative controls. The lab and methodology are certified under the Clinical Laboratory Improvement Amendment (CLIA). The test has not been reviewed by the Federal Food and Drug Administration (FDA). The FDA does not require the test to undergo premarket review.
For more information including the LDT Validation study and IASP 2018 and 2020 results for this testing service, please visit www.enablebiosciences.com
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