Product Development Failure: OncoCyte's success hinges on the successful and timely development, clinical validation, and regulatory approval of its diagnostic tests, a process fraught with high risk and potential for failure or significant delays.

Regulatory Approval Delays or Denial: Obtaining necessary regulatory approvals from agencies like the FDA is a complex, costly, and uncertain process, and there is no guarantee that OncoCyte's products will receive approval, or that approvals will be timely.

Limited Market Acceptance: Even if approved, there is no assurance that OncoCyte's diagnostic tests will achieve widespread market adoption, acceptance by clinicians, or commercial success against existing or future competing technologies.