Launch New LDTs Faster

PraediGene helps clinical and molecular labs validate new tests while automating the documentation you need for CLIA, CAP, and FDA compliance.

The Pressure to Move Faster Is Real — So Is the Risk

Clinical labs are under increasing pressure to bring new LDTs online quickly — but manual workflows, inconsistent documentation, and regulatory complexity make that harder than ever.

PraediGene simplifies and accelerates LDT development with a structured, automated platform that supports your validation process from start to finish.

Validate and launch LDTs in less time
Auto-generate and manage audit-ready documentation
Maintain compliance with CLIA, CAP, and FDA
Eliminate the burden of rework and reduce manual cycles
Improve throughput without increasing headcount

Let’s Make Your Next LDT Launch Smooth and Your Next Audit Simple

Tell us a little about your lab, and we’ll follow up with a short overview or demo — no pressure, just clarity.