Lab Buildout & Startup
From concept to a working, compliant laboratory
Building a clinical lab is a construction project, a licensing project, and a science project at the same time — and the three have to land together. Zilgene guides new laboratories through the full buildout: the applications, the floor plan, the instruments, the test menu, and the documentation, so your lab opens on time and passes its first inspection.
Who it's for
- Physician groups adding an in-office or reference laboratory
- Hospitals and health systems expanding testing capacity
- Entrepreneurs and investors launching a new lab business
- Existing labs adding a new department or testing modality
Testing areas we build out
- Molecular testing (COVID-19 PCR, respiratory panel, UTI, STI, and more)
- Hematology
- Chemistry
- Toxicology
- Flow cytometry
- Cytogenetics and FISH
- Anatomic pathology
- IHC and ISH
- Microbiology
How an engagement runs
- Discovery and feasibility. We start with what you want the lab to do — specialties, test menu, expected volume, location. You get an honest read on what's realistic: the licenses you'll need, the rough timeline, and the decisions that drive everything else.
- Licensing strategy. We map every application your lab needs — federal CLIA certificate, state-specific licenses (California, New York, Florida, and others), and any accreditation applications — and file them in the right order so nothing sits waiting.
- Facility and layout. We review your floor plan against laboratory workflow and regulatory expectations: specimen flow, contamination control for molecular areas, space for instruments and staff, and what inspectors look for when they walk the space.
- Instrument selection and procurement. Based on your test menu and volume, we help you compare instruments and vendors, evaluate service contracts, and avoid buying equipment that can't support your claims.
- Test validation and verification. We support the full validation/verification package for each assay — protocols, acceptance criteria, documentation — so your test menu is defensible from day one.
- Documentation and go-live. Standard SOPs, requisition forms, and patient reports that meet CMS requirements are built before you open, not after. We walk through a readiness checklist with you so launch day isn't a scramble.
- Post-launch support. After go-live, we stay available to close loose ends: inspection prep, corrective actions, and adjustments as volume grows.
What you get
- A clear licensing and timeline roadmap for your specific lab
- Filed CLIA, state, and accreditation applications
- Floor plan and workflow review
- Instrument selection guidance with vendor comparisons
- Complete validation/verification documentation
- Ready-to-use SOPs, requisition forms, and CMS-compliant report templates
- A go-live readiness checklist and walkthrough
FAQ
How long does it take to build a lab? It depends on the scope — a focused specialty lab moves faster than a multi-department reference lab. After the discovery step, you'll have a realistic timeline for your project, and the first consultation to scope it is free.
Can you build just one department or add a new test? Yes. We handle full buildouts as well as targeted additions — a new molecular line, an added toxicology bench, or a single new assay with its validation package.
Do you work with our architect and contractor? Yes. We review plans and flag laboratory-specific requirements so the build matches what regulators and inspectors expect.
Do you stay involved after the lab opens? Yes — post-launch support is part of the engagement, covering inspection readiness and any corrective actions as the lab ramps up.
Start the conversation
Every engagement is scoped and quoted upfront — no open-ended hourly billing. The first consultation is free, and you'll know the exact cost before any work begins.