What are In vitro diagnostics?

Companion Diagnostic, also known as in vitro diagnostics, are medical devices used to help determine whether a particular therapeutic product, or therapeutic approach, would be suitable for a particular patient based on the expression of a biomarker. These diagnostics help identify which patients are most likely to benefit from a specific targeted therapy and avoid treating patients that will not respond or could be harmed.

How Do In vitro diagnostics Work?

In vitro diagnostics work by testing for specific biomarkers, such as proteins, genes or other molecules, that are unique to a patient's DNA or tumor. These biomarkers help determine if a patient's cancer cells have certain genetic mutations or expressions that make them responsive or non-responsive to a particular targeted therapy. By detecting these biomarkers, the diagnostic is able to "companion" a specific therapeutic and help select appropriate treatment options for an individual patient.

The Role of Biomarkers

Companion Diagnostics play a key role in the development and use of in vitro diagnostics. Biomarkers are biological molecules found in blood, other body fluids or tissues that are indicators of normal or abnormal processes, or of a condition or disease. In cancer care, biomarkers can help identify cancer subtypes and mutations that may predict a patient's response to specific therapies.

Some common cancer biomarkers tested by Companion Diagnostic include HER2 for breast cancer therapies like Herceptin, KRAS and EGFR mutations for colorectal and lung cancer drugs, and BCR-ABL mutations for chronic myeloid leukemia treatments. By detecting these biomarkers, clinicians can select the right targeted therapy and avoid ineffective or harmful treatments for patients not expressing the biomarker. This leads to more personalized and precise cancer treatment plans.
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