Proteomics is taking the mystery out of treatment effectiveness and creating tight relationships between some drugs and medical devices.
Proteomics is to proteins what genomics is to DNA. Proteomics is the study of proteins that the organism produces, including the differences between proteins in healthy and unhealthy individuals and between diseased and healthy tissues.
Until recently, when the Food and Drug Administration approved a drug, the agency was declaring that the drug was a safe and effective treatment for many patients. However, the agency did not know for whom the drug would be effective. Particularly in cancer treatment, no one understood why a drug helped some patients and was unhelpful or harmful to others.
However, better scientific understanding of how drugs work has led to companion diagnostic devices, defined by the FDA: “An IVD companion diagnostic device is an in vitro diagnostic device that provides information that is essential for the safe and effective use of a corresponding therapeutic product.”
A companion diagnostic device helps to ensure the safety and effectiveness of its drug. For instance, in October 2015, the FDA approved a drug to treat advanced non-small cell lung cancer with tumors that produce PD-L1, an immune cell protein. This approval included the drug’s use with a companion diagnostic device that detects the PD-L1 protein in lung tumors.
The drug and the device work together to improve patient treatment. Before lung cancer patients take this drug, they undergo tissue testing with the companion diagnostic device. If their tumors have PD-L1 proteins, then their doctor knows they are among the patients most likely to benefit from the drug.
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