Is OncuraKit a diagnostic test?

No — OncuraKit is explicitly a screening test, not a diagnostic test. This distinction has important clinical and regulatory implications. A screening test is designed to identify individuals in an apparently healthy population who may be at risk for a specific condition and warrant further diagnostic evaluation. A diagnostic test is designed to confirm or rule out a specific condition in someone who presents with symptoms or a prior positive screen. OncuraKit's results — Normal or Elevated miRNA expression — are screening signals that should always prompt clinical follow-up for interpretation. An Elevated result does not constitute a cancer diagnosis. A Normal result does not guarantee cancer-free status. All results must be interpreted by a qualified physician in the context of your complete clinical picture.