Yes, GENEWIZ is licensed by CMS (Centers for Medicare and Medicaid Services) under the Clinical Laboratory Improvement Amendments of 1998 as qualified to perform high complexity clinical laboratory testing. GENEWIZ holds clinical lab licenses from the states of NJ, PA, CA, RI and MD.
CLIA Sanger sequencing is performed in the CLIA-certified/CAP-accredited laboratory using CLIA-qualified personnel and equipment. Sample and reagent tracking for each order with a review of the final documentation by our Quality Assurance team and our laboratory director is also provided.
You will receive the original sequencing results in a chromatogram (.ab1 files), the sequence files (.seq files), and the quality files (.phd files) along with a quality report which contains the quality score and contiguous read length per trace. For an additional fee, you can request a lab director signed report which will indicate that the order was processed within a CLIA-compliant workflow.