Article | July 12, 2018

Companion Diagnostic Development: Current Trends And Recommendations

Source: Q2 Solutions
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By Patrice Hugo, Ph.D., Chief Scientific Officer, Q2 Solutions and Richard Heichemer, M.S., M.B.A., Scientific Advisor Companion Diagnostics, Q2 Solutions

Companion Diagnostic Development: Current Trends And Recommendations

In today’s market, there is tremendous downward pressure for reimbursement. We’ve seen a long-term shift in the laboratory business model from using complex regional laboratories to physician office labs and point of care testing.

We have also seen a focus in the market toward smaller populations to be treated with specific drugs, not only for orphan indications or rare diseases, but also in major indications like cancer, where targeted drugs are being used to only address patients whose tumor is harboring specific mutation(s).

We’ve also witnessed technical shifts in the laboratory services offered, from routine or safety testing (e.g. chemistry, coagulation, urinalysis, hematology, serology, hormone testing) to highly complex testing, such as 10+ color flow cytometry, molecular pathology and genomics (e.g. Next Generation Sequencing [NGS]).

Examining the trends in personalized medicine sheds light on ways to create successful partnerships between sponsors, laboratories, and manufacturers of in-vitro diagnostic products (IVDs) to develop more efficiently stand-alone diagnostics, companion diagnostics (CDx), and complementary diagnostics. This is particularly relevant in light of the paradigm shift on the horizon for developing and ensuring reimbursement of such personalized medicine solutions with new technologies. Download this article to learn six strategies for success when developing your companion diagnostic.