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Assay Development
& Validation

NextPhaseDx provides consultative and technical guidance to help academic teams and start-ups transition from early biomarker discovery into structured, regulatory-ready diagnostic development.
We support assay design under FDA Design Control principles — defining requirements, managing risks, and documenting verification and validation activities aligned with CLSI standards and QMSR expectations.
Our approach ensures that analytical studies, documentation, and design history files are ready to support clinical validation and eventual regulatory clearance.

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Our Expertise

We bring hands-on experience across multiple diagnostic platforms and regulatory frameworks, ensuring every developmental step aligns with both scientific rigor and FDA Expectations

  • Experience across ELISA, flow cytometry, molecular, and hematology platforms

  • Development guided by CLSI standards and FDA design control principles

  • Strategic analytical and clinical validation aligned with regulatory-clearance milestones

  • Available for collaboration as a small business prime or subcontractor under SBIR and STTR programs to support assay development and validation studies.

Whether you're establishing your first regulated assay or refining an existing platform for submission, NextPhaseDx provides structured, compliant development support tailored to your assay development stage.

Ready to Accelerate Your Diagnostic Development?

Let’s discuss how NextPhaseDx can help guide your assay from discovery to validation and regulatory success.
Complete the short form below and we’ll connect within one business day.

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