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Medical diagnostic tests are an integral part of our health care system.
These tests are performed on samples taken from the body and are used in a broad range of applications.
From the genetic tests that inform personalized cancer treatment to the blood analysis that identifies the right antibiotic to fight an infection, diagnostic tests provide critical insights at every stage of medical care - prevention, detection, diagnosis, treatment and successful management of health conditions.
Diagnostic tests are performed in laboratories, hospitals, physicians' offices, clinics, on the field, and in the home. They facilitate evidence-based medicine, improve quality of care, promote wellness, enable early detection of disease and reduce overall health care costs.
Companion diagnostics are an emerging area of diagnostics receiving a lot of attention. Companion diagnostics are tests that provide information about genomic and proteomic characteristics to help inform use of a specific drug or therapy.
FDA has created a new web page to reference approved or cleared companion diagnostics supporting therapeutic product’s safe and effective use as a resource to the public. The site can be found here.