Process with a Purpose
The development of new laboratory tests give patients and healthcare practitioners reason to anticipate and expect advancements in the tools used to diagnose and monitor a range of conditions and diseases. If a new test is to become a commonly-used, safe, and effective clinical tool, it will proceed from concept through development, validation, approval, and favorable coverage decisions to acceptance and use. While the process has many steps and does take time, it ensures that the tests we as patients rely on for accurate information about our health are effective and have earned the confidence of regulators and our healthcare providers. The process helps to ensure that new laboratory tests successfully balance the need for medical advancements with patient safety.
Continue to the next article in the series: Part II: Commercial Tests and FDA Approval