Abstract
Companion diagnostics are tests which are used to guide targeted therapies. They represent the application of knowledge of unique sensitivities of hosts or diseases. The FDA approved the first companion diagnostic-related drug, trastuzumab (Herceptin), in 1998. Trastuzumab is specifically effective in human epidermal growth factor receptor 2 (HER2) positive cancers, which are associated with poor outcomes with conventional cytotoxic therapy. Since trastuzumab, many other companion diagnostics have been brought to market. There are both health and economical advantages to developing companion diagnostics. With personalized therapy, patients will experience fewer and less severe side effects, and patients are more likely to have positive outcomes. Companies seeking to approve companion diagnostics will be able to recruit fewer participants for efficacy trials, leading to decreased development costs. Challenges to the future of companion diagnostics include preventing off-label usage of drugs. Additionally, the likely expensive cost of companion diagnostics, as in the example of ivacaftor (Kalydeco), will raise questions on how these drugs will be paid for.
Highlights
Companion diagnostics are tests which are used to guide targeted therapies
An emphasis on personalized therapy tailored to patients based on diagnostic testing ensures maximum effectiveness
Research on companion diagnostics was first launched with Food and Drug Administration (FDA) approval of the first companion diagnostic related treatment, trastuzumab (Herceptin), in 1998.1 By interfering with the human epidermal growth factor 2 (HER2) receptor, overexpressed in around a third of breast cancers, human epidermal growth factor receptor 2 (HER2)-positive patients went from having some of the worst outcomes to more favorable ones
Summary
Trastuzumab is effective in human epidermal growth factor receptor 2 (HER2) positive cancers, which are associated with poor outcomes with conventional cytotoxic therapy. An emphasis on personalized therapy tailored to patients based on diagnostic testing ensures maximum effectiveness Nowhere is this trend more evident than in the rapidly evolving field of oncology, where pairings between drugs and corresponding diagnostic tests allows physicians to determine clinical utility. Research on companion diagnostics was first launched with FDA approval of the first companion diagnostic related treatment, trastuzumab (Herceptin), in 1998.1 By interfering with the human epidermal growth factor 2 (HER2) receptor, overexpressed in around a third of breast cancers, HER2-positive patients went from having some of the worst outcomes to more favorable ones. A study of 199 compounds developed for the treatment of NSCLC found that only 11% passed the entire regulatory process, but drugs that used biomarkers to guide their administration had a 62% regulatory approval success rate.[5]
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