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Specialized Support For Complex Sequencing Workflows

Long-read sequencing reveals biological signals that conventional methods often miss, but translating those signals into clinical assays requires more than sequencing alone. Renew combines clinical Nanopore expertise, internal R&D, and sample strategy to help partners move complex workflows from concept to clinical deployment.
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Clinical Nanopore Translation
Advance ONT-based workflows through long-read expertise, native-read applications, and clinical translation.
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R&D-Driven Development
Develop, optimize, and characterize complex assays before validation or regulated deployment.
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Sample Strategy for Validation
Plan cohort access, sample feasibility,
and evidence generation for complex validation studies.

Fit-for-Purpose
Evidence Generation

Every development program has a different objective. Renew tailors study design, analytical rigor, documentation, and validation strategy to each workflow's intended use, regulatory pathway, and development milestone.

Whether supporting RUO verification, GCP-compliant studies, CAP/CLIA implementation, or FDA-facing analytical validation, we generate the evidence required for the next decision.
Evidence built for every stage of development
Fit-for-purpose RUO verification
GCP-aligned clinical and translational studies
CAP/CLIA validation planning and execution
FDA-facing analytical evidence generation

Plan. Develop. Verify. Validate

A fit-for-purpose path to clinical and regulatory readiness
1. Plan
Define intended use, development strategy, sample requirements, 
and evidence needs.
2. Develop
Build and refine wet-lab workflows, bioinformatics, QC frameworks, and analytical outputs.
3. Verify
Establish analytical performance across research, translational, or clinical development studies.
4. Validate
Generate analytical and clinical evidence aligned to implementation and regulatory objectives.
5. Submit
Support regulatory strategy, submission documentation, and agency interactions.

Built for Clinical Deployment

Clinical deployment is built into our development model, allowing programs to transition seamlessly from validation into routine clinical execution.

Regulatory-aligned laboratory operations, specialty bioinformatics, LIMS, API-enabled data delivery, validation documentation, QC systems, and change control provide the operational foundation for scalable testing and long-term program growth.

Infrastructure for clinical translation
15,000 square feet of dedicated sequencing and development space
CAP-accredited, CLIA-certified laboratory operations
HIPAA-aligned processes for clinical and partner programs
Custom LIMS-enabled sample and workflow tracking
Specialty bioinformatics for complex sequencing workflows
Partner Highlight

Path Fertility’s NOA GUIDE™

Path Fertility partnered with Renew to develop and validate NOA Guide, an epigenetic test for men with non-obstructive azoospermia, a condition characterized by impaired sperm production despite no physical obstruction.

Renew provided assay development, validation, and clinical laboratory implementation, translating novel epigenetic biology into an operational diagnostic with real-world clinical utility.

Develop and Validate with Confidence
Advance from development to deployment with a fit-for-purpose validation strategy aligned to your workflow, intended use, and next milestone.
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