"The FDA last year finalized its companion diagnostics guidance, in which the agency reaffirmed its preference for simultaneous development of a drug alongside its companion diagnostic..."

At CDx Harmonization Meeting, Drugmakers Take First Step At Exploring Test Differences

Mar 25, 2015

 

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Turna Ray

"According to the FDA, a drug sponsor must develop a companion diagnostic when the test is essential for the safe and effective use of the drug, or in other words a CDx enables the drugmaker to meet FDA's safe and effective requirement by identifying a best responder population for a drug. The FDA last year finalized its companion diagnostics guidance, in which the agency reaffirmed its preference for simultaneous development of a drug alongside its companion diagnostic, but laid out a few exceptions when other development paradigms might be acceptable.

However, as more companies are advancing drugs with companion tests utilizing a precision medicine strategy, several problems have emerged. When there are multiple FDA-approved companion diagnostics for the same class of drugs, it becomes costly for hospitals to adopt all of them and confusing for doctors to figure out which test to order. Then there is the tissue problem. For certain malignancies, such as lung cancer, it is challenging enough to get sufficient tissue to run standard analyses for diagnoses, but usually not enough tissue material to run multiple, proprietary companion tests in order to figure out which drug in a class to prescribe."