The United States Food and Drug Agency (US FDA) require the development of companion diagnostics (CDx). CDx can help to identify patients at risk and guide patient selection. Moreover, it serves as a marker for treatment outcome. Thus enabling physicians to better balance safety with efficacy. The US FDA motivates the development of a CDx in early stages of clinical studies.
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The number of different types of T-helper cells (Th) and cytotoxic T cells (CD8) may predict response to ipilimumab in several malignancies. This was concluded by Dr Juan Pablo Márquez Manríquez who presented the study at the ESMO conference on behalf of the investigators of the Sonora Cancer Research Center (CICS) in Mexico and the United States (U.S.).
Recent studies have shown new possible applications for Ki67. Huh et al. showed that low Ki67 levels in healthy breast tissue correlated with a lesser lifetime chance of breast cancer. Another study by Arnedos and colleagues concluded that palbociclib was able to invoke a significant Ki67-level drop. After a decade of Ki67-controversies, these results put the marker back in the spotlight.