Assay Go-Live & Patient Reports

A controlled path from validated to live—and patient-ready PDFs after.

When validation is complete, submit the assay for approval and a director takes it live. Live profiles interpret production runs, and approved samples produce patient report PDFs. Re-validation after go-live is supported when a panel changes.

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Capabilities

What you can do

Submit → Approve → Live

A visible lifecycle with the right people at each step.

Validation summary

Status and evidence in one place for the director.

Patient report PDF

Generated for approved samples in profile mode.

End-to-end checklist

A built-in testing checklist mirrors how labs actually bring a panel live.

Connected features

Works hand in hand with

PCR & Molecular

Analytical Validation (LOD & Cutoffs)

LOD, Ct distribution, and cutoff suggestion on your actual runs.

LOD study analyzer
Ct distribution analyzer
Cutoff suggestion engine

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PCR & Molecular AI

Clinical Validation Packets

Reconcile known truth against instrument results—automatically.

Deterministic reconciliation
Smart sample matching
Audited adjustments

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Quality & Validation

Reviewer & Director Sign-Off

Two-step approval, immutable lock, PDF validation packet.

Approval timeline
Lock & immutability
Validation packet

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See Assay Go-Live & Patient Reports in action.

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