Companion diagnostics (CDx) hold the promise to make drug therapies safer and more effective. At the same time, breaking the conventional trial-and-error cycle for prescription medications makes health care more cost-efficient by allowing health care providers to give the right drug to the right patient. Pharmaceutical companies increasingly understand that incorporating a CDx strategy into drug development programs at early stages may expedite trials and, ultimately, the drug approval process. Utilization of CDx at a time when the health care market is increasingly focused on achieving improved outcomes and cost efficiencies in turn further drives continued interest in CDx test development. To date, CDx development has been achieved largely through partnerships between pharmaceutical and diagnostics companies. Big name diagnostic companies such as Abbott Molecular, Qiagen, and Foundation Medicine are deeply invested in these partnerships. Currently, 155 pharmacogenomic biomarkers are included in Food and Drug Administration-approved drug labels. The pharmaceutical industry is invested in a more customized drug development model. The Personalized Medicine Coalition estimates that 30 percent of all treatments in late clinical development rely on biomarker data, as do 50 percent of all treatments in early clinical development and 60 percent of all treatments in preclinical development. ‘“If we […]