Update on molecular companion diagnostics - a future in personalized medicine beyond Sanger sequencing.

Update on molecular companion diagnostics - a future in personalized medicine beyond Sanger sequencing. Expert Rev Mol Diagn. 2020 Mar 13;: Authors: Campbell MR Abstract Introduction: The merging of molecular diagnostics with personalized medicine has led to a surge in development of molecular-based companion diagnostics. Companion diagnostics, defined as "a medical device, often an in vitro device, which provides information that is essential for the safe and effective use of a corresponding drug or biological product", are key to the appropriate utilization of several pharmacotherapies; primarily in the area of oncology. Areas Covered: While most molecular companion diagnostics are targeted towards oncology, the potential to multiplex assays will contribute to an expansion in the applications of companion diagnostics for an increasing menu of disease states and conditions including areas such as infectious disease, cardiology, and hematology.Expert Opinion: With this innovation comes the responsibility to ensure molecular companion diagnostic devices are robust and controlled against the detrimental effects of false positive/negative results. Additional important considerations, such as paired development with pharmaceutical companies and adherence to Food and Drug Administration and/or European Union guidelines, must be addressed. While the current number of companion diagnostics is relatively small, as molecular assays continue t...
Source: Expert Review of Molecular Diagnostics - Category: Laboratory Medicine Tags: Expert Rev Mol Diagn Source Type: research