What CLIA Certification Means (and Why We Won't Work Without It)

CLIA certification means a lab has met federal quality standards for accuracy and reliability — the same standard required for the lab that runs your blood work — and at Mosaic, every sample is processed in a CLIA-certified laboratory. When you hand over your DNA, you're trusting that the lab handling it knows what it's doing. Not all labs are held to the same standard.

What CLIA is

CLIA stands for Clinical Laboratory Improvement Amendments. It's a federal regulatory standard managed by the Centers for Medicare & Medicaid Services (CMS) that applies to any lab performing testing on human specimens. CLIA certification means a lab has met specific quality standards for accuracy, reliability, and proper handling of biological samples.

It's the same certification required for labs that run your blood work, pathology, or diagnostic testing. It's not optional for clinical work, and we believe it shouldn't be optional for genomics either.

Why it matters for DNA testing

Your genome doesn't change. The results from a whole genome sequencing test will be referenced for years, maybe decades. If the sequencing isn't done accurately, the insights built on top of it won't be reliable either.

CLIA certification means the lab undergoes regular inspections, follows documented procedures, employs qualified personnel, and participates in proficiency testing. It's a system of checks that exists specifically to reduce errors in testing.

Not every DNA company uses one

Some direct-to-consumer DNA companies use labs that don't carry CLIA certification. That doesn't necessarily mean their results are wrong, but it does mean they're not subject to the same level of regulatory oversight. For something as personal and permanent as your genetic data, we think the highest standard should be the baseline.

Our approach

Mosaic uses 30x whole genome sequencing processed through a CLIA-certified lab. That means every one of the 108 insights in your report is built on data that meets clinical-grade accuracy standards. It's not a shortcut we're willing to take. You can read the full picture of our standards on our lab and standards page.