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Mosaic Biodata

Mosaic · Lab & Standards

Clinical-grade. By every standard that matters.

Mosaic’s lab partner holds the four accreditations every U.S. clinical reference lab runs on (CLIA, COLA, CAP, AABB), plus permits and licenses in five of the strictest states. The same standards your doctor’s reference lab is held to.

Our lab partner’s accreditations

The headline four.

Every result that comes back from a Mosaic kit is run at a U.S.-based clinical reference lab held to the full clinical-grade accreditation stack. Each accreditation is awarded by an independent body and renewed under inspection.

  • CLIA accredited — Clinical Laboratory Improvement Amendments

    Clinical Laboratory Improvement Amendments

    The federal standard for clinical laboratory testing. Every lab that returns results used in patient care must meet CLIA — and most consumer DNA companies stop at this baseline.

  • CAP accredited — College of American Pathologists

    College of American Pathologists

    The most rigorous lab accreditation in the U.S. The same standard major hospital reference labs are held to.

  • COLA accredited — Commission on Laboratory Accreditation

    Commission on Office Laboratory Accreditation

    An additional quality-and-process review layer on top of CLIA. Inspectors look at every step — sample handling, calibration, documentation, staff training.

  • AABB accredited

    AABB (originally American Association of Blood Banks)

    Originally the accreditation for blood banking. Now a leading body for accrediting molecular and genomic testing labs as well.

State oversight

Five additional state regulators.

Our lab partner is permitted or licensed by the state clinical-lab regulators below. New York, California, and Maryland run oversight strict enough to effectively require national-grade accreditation to maintain.

Clinical laboratory permits

  • New York State Department of Health

    New York

  • Pennsylvania Department of Health

    Pennsylvania

  • Maryland Department of Health

    Maryland

Clinical laboratory licenses

  • California Department of Public Health

    California

  • Rhode Island Department of Health

    Rhode Island

These permits aren’t easy to hold. NY, CA, and MD audit procedures, staff credentials, sample-handling chain, and calibration records on top of what the national accreditations already require.

In buyer terms

What the credential stack means for you.

Variant calls reliable enough to act on. At 30× depth every position is read thirty times; the pipeline filters errors, confirms calls against reference data, and flags anything ambiguous instead of guessing.

Data you can take to any provider. Your practitioner, endocrinologist, or geneticist doesn’t have to take Mosaic’s word for it — the accreditations match the reference lab your doctor already uses.

Not a consumer genotyping pipeline pretending to be clinical. A SNP-chip ancestry test runs on different equipment and a different regulatory standard, and that distinction matters when you’re deciding whether to act on the data.

Inside the pipeline

How a Mosaic sample becomes a report.

The six-step lab pipeline: sample arrival, quality control, sequencing, alignment, variant calling, report generation

Your sample enters the same clinical-grade workflow that runs reference-lab work for hospitals and genetic counselors: short-read whole-genome sequencing on a current-generation Illumina instrument, at 30× depth across the full genome.

Depth is how many times each position is read. Read it once and you can’t tell a real variant from a sequencing error; read it thirty times and the call is reliable enough to act on. Most consumer tests don’t run at clinical depth at all.

From there, reads pass through quality control, alignment, and variant calling — identifying every position where your DNA differs from the reference. The output is a standard VCF any interpretation tool can read.

Mosaic’s side starts there: we pull the variants behind each insight, score them against the literature, and render your report. The raw VCF stays yours, indefinitely, usable with any tool that reads genomic files.

A note on methodology

We don’t impute from reference panels.

Some platforms use a method called imputation — they statistically guess at positions they never actually read, based on patterns in reference populations. We don’t. If your data doesn’t cover a position, the report tells you. The blanks stay blank.

The same rule applies on the BYOD path — full technical disclosure here.

Mosaic data security & privacy

Your genome stays yours.

Mosaic runs a HIPAA-compliant data pipeline. Your sample is pseudonymized before it leaves your kit; the lab works with an anonymized identifier and never sees your name. Files are encrypted in transit and at rest, and access is logged.

Retention is on your terms. Download your raw data anytime, in standard formats, and use it anywhere. If you ever want it gone, the right to delete is built in.

We never sell, share, license, or monetize your genome. Not now. Not ever. This is the one promise we’re willing to make in absolute terms.

Clinical-grade, whichever way you use it.