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Assay Development
& Validation

Translating biomarker discoveries into

FDA-aligned diagnostic development

NextPhaseDx partners with academic and early-stage industry teams to support the transition of promising biomarker discoveries into structured assay development programs aligned with FDA design control expectations. Our work focuses on introducing development discipline, regulatory awareness, and technical judgment at the point where exploratory research begins to take on regulatory significance.

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We emphasize assay development approaches that preserve scientific intent while establishing the documentation, risk management, and validation planning needed to support downstream regulatory review. This ensures that early technical decisions are made with a clear understanding of their regulatory implications.

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Our Expertise

Applying development discipline and regulatory context to diagnostic assay programs

  • Assay design and optimization strategy informed by intended use
  • Platform selection and technology transition considerations
  • Planning for analytical validation aligned with regulatory expectations
  • Integration of risk management and design inputs into development activities
  • Preparation of development documentation appropriate for future FDA review
Whether teams are advancing early feasibility work or preparing for more formal validation activities, NextPhaseDx provides experienced guidance to help ensure assay development progresses in a manner that supports regulatory alignment, technical rigor, and long-term program success.
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