Is your test validated using clinical samples?

UNITY test is offered by BillionToOne, a CLIA licensed laboratory. Our test is validated using clinical samples following CLIA (Clinical Laboratory Improvement Amendments) regulations. We have conducted 2 clinical studies where we ran single-gene NIPT on over 40 samples, and we were able to show 100% concordance with the newborn screening results https://www.biorxiv.org/content/10.1101/597732v1