A medical device, frequently an in vitro device, is a companion diagnostic. It offers information necessary for the safe and efficient use of a matching medicine or biological product. The test aids a medical expert in determining whether the advantages to patients of a specific medicinal product will outweigh any potential serious dangers or side effects.
Companion diagnostics can:
• Identification of patients most likely to benefit from a specific medicinal product is possible with the use of companion diagnostics.
• Determine which people are more likely to experience major side effects from a specific medicinal substance; or
• Track patient response to a specific medicinal product in order to modify the course of treatment for increased safety or efficacy.
When oncologists are treating advanced cancer patients, they need to move quickly from insight to action. To do so, they need comprehensive, reliable information about what is driving a patient’s cancer so they can make personalized treatment decisions. We’ve forged a path forward to achieve the highest quality standards for our tests – to both improve adoption of comprehensive genomic profiling (CGP) and access to this technology in the clinic.
The variability of pharmacotherapy can be of a significant magnitude, and the main reason for this is often diseases heterogeneity. Patients who have similar diagnoses very often respond differently to the same pharmacological intervention, with great variability in both efficacy and safety outcome. Despite having discussed personalized medicine for more than a decade, we still see that most drug prescriptions for severe chronic diseases are largely based on ‘trial and error’ and not on solid biomarker data. However, with the advance of molecular diagnostics and a subsequent increased understanding of disease mechanisms, things are slowly changing.
