Future outlook, Trend, and Importance of Companion Diagnostics

 


A companion diagnostic (CDx) is a diagnostic test that is used in conjunction with a therapeutic drug to determine its suitability for a specific individual. Companion diagnostics are co-developed with drugs to aid in the selection or exclusion of patient groups for treatment with that specific drug based on biological characteristics that determine responders and non-responders to therapy. Companion diagnostics are based on companion biomarkers, which help predict likely response or severe toxicity in the future.

Popularity of Companion diagnostics

The number of companion diagnostics on the market is rapidly increasing. According to data compiled by the Personalized Medicine Coalition, there were five drug/diagnostic combinations that met the FDA definition of a companion diagnostic in 2006. These were as follows:

         I.            Invader UGT1A1 Molecular Assay and Camptosar (irinotecan)

       II.           Gleevec (imatinib mesylate) and BCR-ABL LDT, as well as DAKO C-KIT PharmDx, are treatments for gastrointestinal stromal tumors (GIST)

     III.           Herceptin (trastuzumab) and DAKO Herceptest are two drugs that are used to treat breast cancer.

    IV.            Purinethol (mercaptopurine) and a thiopurine methyltransferase test developed in the laboratory.

      V.            Tamoxifen (Nolvadex) and a laboratory-developed oestrogen receptor positive test.

Future of Companion diagnostics

The future growth of companion diagnostics will be dependent on a healthy ecosystem. To be healthy, the ecosystem requires a diverse set of players. The major players must include drug developers who continue to develop targeted therapies based on biomarkers, diagnostic firms capable of developing new diagnostic tests, and regulators who are willing to approve drug-diagnostic combination products. The economic incentives for continuing to develop companion diagnostics are strong. With less expensive clinical trials, drug developers can achieve a faster time to market for drugs with significant revenue potential. Based on targeted therapies, regulators see the potential for more directed regulatory submissions with fewer adverse events. Payers see the potential savings from avoiding unnecessary treatments. However, diagnostic firms are the only group for which the companion diagnostics business model is still unknown. This is especially true for diagnostic companies attempting to develop theragnostic.

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