Resources
Frequently asked questions
Straight answers on lab startup, compliance, reimbursement, and molecular testing.
FAQ
Lab startup & setup
How long does it take to stand up an in-house PCR lab?
It depends on your space, staffing, and certification path, but a focused engagement typically moves from initial consultation to go-live in a matter of months. We give you a realistic timeline up front.
What does it cost to build an in-house lab?
The major drivers are instruments and consumables, space and buildout, qualified staffing, and certification/validation. We model your specific ROI and reimbursement before you commit.
Do you help with the physical lab buildout?
Yes. We design an efficient floorplan for your footprint and can manage the full buildout, standardizing layouts across multiple locations for consistency.
FAQ
Compliance & accreditation
What's the difference between CLIA and COLA?
CLIA is the federal law governing all US clinical lab testing; COLA is one accreditation body approved to assess your compliance with it. Molecular PCR is high-complexity, which carries specific personnel and quality requirements.
Which certifications does my lab need?
That depends on your test menu and setting. We help you determine the right certifications and support applications, enrollment, and inspection readiness end to end.
Do you support CAP accreditation?
Yes, our validations can be tailored to cover CAP accreditation so your lab is audit-ready. Request CAP accreditation be added to your standard validation by contacting your Sales representative or Validation specialist.
FAQ
Reimbursement & revenue
Will in-house testing actually pay for itself?
For many practices, yes — it keeps reimbursement in-house and shortens turnaround. We build a personalized ROI and reimbursement analysis from your anticipated volumes and payor mix so you can decide with real numbers.
Do you help with billing and coding?
We provide financial analysis, reimbursement guidance, and fee-schedule review, and help you understand coverage requirements such as the MolDX program for molecular tests.
FAQ
Molecular & validation
How does PCR assay validation work?
We use a proven five-phase approach — planning, protocol design, supply sourcing, training, and post-validation support. See our Validation Services page for details.
What is MolDX and does it affect my lab?
MolDX governs coverage and reimbursement for molecular diagnostic tests in participating Medicare jurisdictions. If you bill Medicare for molecular testing there, it likely applies. See our detailed MolDX FAQ.
Can you validate lab-developed tests (LDTs)?
Yes. We confirm LDTs specifically for PCR applications — with on-site teams or ready-to-run validation plates.
Looking for MolDX and coverage specifics? See the detailed MolDX FAQ.