Why doesn't OncuraKit require a prescription?

OncuraKit is a Laboratory Developed Test (LDT) — a category of clinical tests that, under current federal regulations, are offered by CLIA-certified laboratories directly to individuals without requiring a physician's prescription. This is the same framework under which direct-to-consumer genetic testing (like 23andMe health reports) and at-home diagnostic tests (like home cholesterol tests) are offered. The absence of a prescription requirement does not mean OncuraKit is unregulated — the laboratory performing the analysis must be CLIA-certified and maintain the quality standards required by federal law. We strongly encourage you to involve your physician in interpreting your results and in any follow-up decisions, but we do not require a physician order to place your OncuraKit order.