LabCorp, in turn, is contracted to use the Illumina HumanOmniExpress-24 format chip for actual genotyping. These results are then electronically transmitted back to 23andMe where (based on the barcode) they are then matched to the consumer account created during the sign-up process. As the FDA pointed out in the letter, the risk that these tests can produce either a false positive or a false negative is the primary concern of the FDA and its approval process. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.