imaware tests are classified as laboratory developed tests (LDT). LDTs are validated by the laboratory before being used to generate laboratory results for diagnosing or treating a patient. LDTs are not subject to FDA clearance or approval. Overseeing the analytical and clinical validity, alongside clear and compliant communications of results, are CLIA and CAP. These regulatory agencies audit each of our labs twice annually. As the FDA notes, "LDTs are important to the continued development of personalized medicine." So, while they don't receive the classification of FDA-approved, they are recognized as important to innovation within the laboratory space.