Hi there, Many IVD manufacturers know Quest Diagnostics as one of their largest customers. In fact, as the largest diagnostic lab in the country, we utilize instrumentation from nearly every IVD company in the market. When IVD manufacturers develop new assays on their instruments, they need to perform reproducibility studies, typically with a minimum of two external lab partners, in order to demonstrate the robustness and reliability of a test and to demonstrate that the test can be reliably performed by other laboratories using the same or similar equipment and methods. Too often, reproducibility studies are treated as a “check the box” exercise. But FDA reviewers expect rigorous evidence that your assay is robust and transferable. Our white paper, “4 Critical Questions IVD Manufacturers Should Ask When Selecting a Lab Partner,” highlights |