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Diagnostics & Policy

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. 

Diagnostics are a key contributor to the U.S. health care system, powering medical discoveries and transforming patient care. These tests are performed on samples taken from the body and are used in a broad range of applications. Diagnostic tests provide critical insights at every stage of medical care – prevention, detection, diagnosis, treatment and successful management of health conditions. They facilitate evidence-based medicine, improve quality of care, promote wellness, enable early detection of disease and reduce overall health care costs.

AdvaMedDx promotes the value of innovative, safe and effective diagnostic tests and advocates for risk-based regulation of all diagnostics. Currently, the Food and Drug Administration (FDA) has regulatory oversight of all diagnostic tests that are considered to be medical devices, including those manufactured and sold as kits to laboratories, physician offices and patients.

AdvaMedDx seeks payment reform and Medicare fee schedule modernization that recognizes the full contribution of modern diagnostics to health care quality and outcomes. Reimbursement challenges can dampen the incentive for new test development. Furthermore, increased insurer demands for direct evidence of a test’s impact on patient outcomes, cumbersome coding regimes, and rate setting approaches that disregard test value create difficult hurdles for new test developers and slow patient access to promising tests that can inform personalized medicine approaches.

Globally, AdvaMedDx collaborates with other diagnostics associations around the world and continues to grow these relationships in support of a global industry community. In addition to AdvaMedDx, the diagnostics associations that now plan to convene on a regular basis include those from Europe, Japan, Australia, Brazil, and Canada.

AdvaMedDx works with numerous federal agencies that work on diagnostics and related topics.

Diagnostic tests are clinical tests that detect, diagnose or monitor disease, and that guide physicians and other clinicians in determining what treatment, if any, a patient may need. Point-of-care, or rapid diagnostic tests, are simple to use in physician offices, at the hospital bedside, clinic, or even in a patient’s home, providing timely results on the spot.