A Quantitative Assessment of Factors Affecting the Technological Development and Adoption of Companion Diagnostics

Abstract

Rapid innovation in (epi)genetics and biomarker sciences is driving a new drug development and product development pathway, with the personalized medicine era dominated by biologic therapeutics and companion diagnostics. Companion diagnostics (CDx) are tests and assays that detect biomarkers and specific mutations to elucidate disease pathways, stratify patient populations, and target drug therapies. CDx can substantially influence the development and regulatory approval for certain high-risk biologics. However, despite the increasingly important role of companion diagnostics in the realization of personalized medicine, in the USA, there are only 23 Food and Drug Administration (FDA) approved companion diagnostics on the market for 11 unique indications. Personalized medicines have great potential, yet their use is currently constrained. A major factor for this may lie in the increased complexity of the companion diagnostic and corresponding therapeutic development and adoption pathways. Understanding the market dynamics of companion diagnostic/therapeutic (CDx/Rx) pairs is important to further development and adoption of personalized medicine. Therefore, data collected on a variety of factors may highlight incentives or disincentives driving the development of companion diagnostics. Statistical analysis for 36 hypotheses resulted in two significant relationships and 34 non-significant relationships. The sensitivity of the companion diagnostic was the only factor that significantly correlated with the price of the companion diagnostic. This result indicates that while there is regulatory pressure for the diagnostic and pharmaceutical industry to collaborate and co-develop companion diagnostics for the approval of personalized therapeutics, there seems to be a lack of parallel economic collaboration to incentivize development of companion diagnostics.

Keywords: clinical adoption; combinational therapy; companion diagnostic; healthcare risk management; healthcare translation; personalized medicine; risk:benefit appraisal; stratified medicine.

FIGURE 1

Companion diagnostic development and regulation concomitant with drug therapy development and regulation. The relationship between a companion diagnostic and therapeutic is unique and economic effects of co-development have yet to be fully realized.

FIGURE 2

Graphical representation of methodology. Analysis proceeded in a stepwise fashion.

FIGURE 3

Significant relationships and non-significant relationships for CDx price. (A) There is a significant relationship between CDx price and the duration of drug treatment (R² = 0.347, p = 0.026) and a significant relationship (B) between CDx price and CDx sensitivity (R² = 0.507, p = 0.004). (C) There is a non-significant relationship between CDx price and revenue of drug (R² = 0.171, p = 0.140) and the total patient population (R² = 0.105, p = 0.256).

FIGURE 4

Number of companion diagnostics approved per year increases. Gray scatterplot shows the individual year of approval for each CDx in this study. Black bar histogram shows the total number of companion diagnostics approved per year in this study.

FIGURE 5

Price ranges of companion diagnostics are wide. Lower boundary determined by Medicare reimbursement for the CPT code most closely associated with test. Upper boundary determined typically by list price of company, obtained from a multiple of sources, such as published literature and personal communication.

FIGURE 6

Surface map for Herceptin CDx shows CDx have an expanding range of prices and greater sensitivity as time goes on. Z axis is specificity of diagnostic and contour represents the price of the diagnostic in relation to its specificity during the year that it was approved. The more specific and expensive, the further back and elevated the peak.