In the ideation phase of a diagnostic test, defining the intended use, target population, and clinical context is essential to guide development strategy and regulatory pathway selection.

During the development and testing phase, assay design, analytical validation, and clinical validation are conducted to ensure accuracy, reliability, and alignment with regulatory expectations and accreditation requirements.

In the marketing submission phase of a diagnostic, comprehensive data are compiled to support FDA clearance or approval, or to ensure the test meets CLIA and/or state requirements for laboratory use and complexity classification.

During the commercialization phase, focus shifts to scaling distribution (if necessary), securing market access, and maintaining compliance with FDA, CLIA, state, and other regulatory requirements to ensure reliable performance in real-world settings.

In the market growth phase, efforts center on expanding adoption through clinical utility data, payer engagement, and strategic partnerships—while ensuring ongoing quality, regulatory compliance, and postmarket support.