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Optimizing Gene Therapy: The Importance Of Companion Diagnostics

As the US Food and Drug Administration now requires companion assays for certain gene therapy products, companies should be aware of the intricacies of developing an accurate test. 

Gene therapy

Gene therapy offers the possibility of new cures, particularly for rare diseases with a genetic basis. As such, it has sparked great interest among researchers, health care providers and patients alike. However, the ideal methods and solutions to unlock the full potential of gene therapies are still being developed.

In recent years, the US Food and Drug Administration has required gene therapy companies to develop tests to screen patients...

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