What validation was required before OncuraKit could be offered as a clinical test?

OncuraKit is a Laboratory Developed Test (LDT) analyzed at a CLIA-certified laboratory. Under the CLIA framework, the laboratory is responsible for establishing and validating the performance of its own LDTs before clinical use. CLIA requires LDT validation to demonstrate: analytical accuracy, precision (reproducibility), linearity (measurement across the expected concentration range), reference intervals (HL threshold), and interference testing. Yenos Analytical completed these validations internally and documented the results in their standard operating procedures. The four published peer-reviewed studies serve as additional public validation. Formal FDA pre-market approval is not required for LDTs under current regulations, though the FDA has issued proposed rules that may eventually require LDT validation data submission.