Part of agency’s efforts to promote development of personalized medicines and diagnostics.
The U.S. Food and Drug Administration today issued a new draft guidance to facilitate the development and review of companion diagnostics – tests used to help health care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft document is intended to provide companies with guidance on the agency’s policy for reviewing a companion diagnostic and the corresponding therapy.
One common type of companion diagnostic looks for whether a patient has a specific gene amplification or protein over-expression that could predict whether a drug might benefit the patient or lead to harm. For example, the FDA in 1998 approved Herceptin (trastuzumab), a breast cancer drug designed to target HER2 gene amplification or HER2 protein over-expression. The drug was approved with a companion test and today testing is routinely performed on women diagnosed with breast cancer to help health care professionals determine whether or not the patient should receive Herceptin.
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[Note from SaneVax: It is no secret that some people are more susceptible to vaccine injuries than others. Why could there not be companion diagnostic procedures to identify these individuals and exempt them from pertinent vaccines also? For instance, those already exposed to vaccine-relevant genotypes of HPV do not benefit from the vaccine – why not run a diagnostic test prior to vaccination to determine whether the individual should receive the vaccine?]