The Promise and Challenge of Molecular Diagnostics

November 5, 2014
The Promise and Challenge of Molecular Diagnostics
Figure 1. Potential for variability in molecular diagnostics workflow

Jonathan Frampton, Ph.D.

Companion diagnostics are bridging the gap between molecular diagnostics and therapeutics, helping to ensure that the right drug is provided to the right patient at the right time. Personalized medicine, with the aid of molecular diagnostics, is providing the exciting possibility of the delivery of cost-effective tailored therapies, based on an individual patient’s genetic code. This is particularly true in the case of cancer.

When applied correctly, companion diagnostics can help identify not only patients who are most likely to benefit from a particular therapeutic product, but also those likely to be at increased risk for serious side-effects as a result of treatment. Accurate diagnostics can also monitor response to treatment with a particular therapeutic product, to achieve improved safety.

As of October 2014, there were 19 FDA-authorized companion tests being used to support decisions on the particular therapy that a patient receives.

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