What is OncuraKit's regulatory status?

OncuraKit is a Laboratory Developed Test (LDT) analyzed at Yenos Analytical LLC, a CLIA-certified clinical laboratory in El Dorado Hills, California. As an LDT, it is regulated under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, which set federal quality standards for all clinical laboratory testing on human specimens. OncuraKit does not have FDA 510(k) clearance or Pre-Market Approval (PMA). It is not FDA-approved or FDA-cleared. This is its accurate and complete regulatory status. The test is legally offered as an LDT under the CLIA regulatory framework — the same framework under which thousands of other clinical laboratory tests are offered in the United States daily.