Lab Site Explains How New Tests Get to Market
March 5, 2010
March 5, 2010--Lab Tests Online, the leading patient resource for information on medical laboratory testing, recently posted a series of articles that explain how laboratory tests are put into practice. The series is intended to help the public to better understand how laboratory tests are developed, validated, and marketed for use by patients and their healthcare providers.
Published in five parts, the series, Putting New Laboratory Tests Into Practice, explores the different paths that take a test from the research phase to its use on patients. Going beyond the recently published FDA Basics: Medical Devices, the articles explore the reasons that new tests are developed, and how “FDA-approved tests” and “lab-developed tests” differ. The series also examines clinical trials and the lesser known designation, humanitarian use device, and how new tests become available to the public through these pathways. All four paths to market are discussed in terms of how the tests are regulated for patient safety.
Among some of the questions answered by the series include:
- Why might physicians choose not to use an FDA-approved test?
- How are lab-developed tests, which don’t require FDA approval, regulated for patient safety?
- Why are tests for some rare diseases exempt from certain approval requirements?
- What mechanisms are in place to minimize risks to patients who participate in clinical trials?
By looking at how tests reach the patient, and not just focusing on how a test is approved for use, the series is able to address the challenges of educating physicians and laboratorians on the benefits of the new test, and persuading insurers that the test is sufficiently effective so as to merit coverage. As is customary on Lab Tests Online, the series of articles was meticulously researched by an experienced health writer and reviewed and approved by a board of editors who represent the leading laboratory professional societies in the United States and Canada.
For almost a decade, Lab Tests Online has helped millions of patients and their families understand the many lab tests that are used to screen for and diagnose a wide range of conditions and diseases, and to monitor their treatment. Winner of numerous awards for the quality of its content, the website provides detailed information on more than 250 lab tests and related topics, such as the meaning of reference ranges and the reliability of lab test results. Putting New Laboratory Tests Into Practice is a rewritten and expanded version of an earlier article on how tests reach the market.