The sequencing of the human genome and the development of low cost microarrays have led to a proliferation of tests of gene expression in many cancers, many of which tests are designed to predict recurrence and guide treatment. Other assays guide the selection of chemotherapeutic regimens. Medicare and private payer reimbursement of these tests depends on providing evidence of 3 types of validity: analytic validity, clinical validity, and clinical utility. PHAR, LLC has a proven track record of developing methodologically sound evidence of clinical utility for a variety of genomic tests, as well as extensive experience in developing tools to communicate these results with managed care payers.
Services relevant to the genomics industry include:
- Prospective studies of the impact of genomic testing on treatment
- Medical record review studies comparing pre- and post-testing recommendations
- Comparisons of assay-based recommendations to national guidelines
- Systematic literature reviews of clinical utility studies
- Interactive budget impact models of the cost of genomic tests
- Cost-effectiveness models of genomic testing compared to usual care