Validated Assays are tested using gDNA from 45 individuals from four ethnicities. The minor allele frequency for each population is available and is shown to be >5% in at least one population.
Functionally Tested Assays meet minimum functionality criteria in testing of 20 gDNA samples, from three ethnic populations and both genders, before shipment upon first order. Minor allele frequency is not calculated.
TaqMan® Drug Metabolism Assays are tested using gDNA from 45 individuals from four ethnicities. The minor allele frequency for each population is available, but rare and mutant alleles may not be present in the test DNA.
Qualified Assays are pre-tested using cell line and tissue gDNAs and/or synthetic templates to meet specific functionality requirements.