Table 4.

Factors to consider when selecting a reference laboratory for pharmacogenetic testing32

Factor	Questions to consider
Laboratory certification	Can results be used clinically? In the U.S., this requires that the laboratory be College of American Pathologists (CAP) accredited and Clinical Laboratory Improvement Amendments (CLIA) certified.
Alleles tested	Does the laboratory test for the minimum set of alleles (i.e. Tier 1 alleles) recommended by the Association for Molecular Pathology (AMP) Pharmacogenomic Working Group? If no AMP recommendations are available for the gene of interest, are the alleles described in CPIC guidelines included? Are there other alleles that affect drug response and occur at an appreciable frequency across ancestry groups? What alleles are other sites testing for clinically?
Financial factors	Is any financial assistance with the cost of testing available for patients from the company?
Sample collection	What kind of sample is required (e.g. blood, buccal cell, saliva)? Is the sample type feasible to collect at your site (e.g. is phlebotomy easily accessible for patients if blood is required)? Does the company provide sample collection materials or do they need to be supplied internally?
Test turnaround time	Will the time needed to get test results returned fit the clinical workflow (e.g. will results be available in time to inform prescribing decisions)?
Return of results	Can results be integrated into the electronic health record as discrete data to allow for automated clinical decision support? If results are returned as Portable Document Format (PDF) reports, how will these be stored in the electronic health record so that they are accessible to clinicians?
Interpretation of results	Does the laboratory provide any interpretation of the results (e.g. assign phenotype based on genotype results)? If so, are interpretations consistent with CPIC guidelines?