Frequently Asked Questions
UNITY™ is the only cell-free DNA test that can assess fetal risk for both recessive conditions and aneuploidies as well as maternal carrier status – all from a maternal blood draw. For recessive conditions, this means receiving the maternal carrier status and a tailored fetal risk score at the same time without needing to collect a paternal sample. Pregnant patients who are carriers no longer need to await paternal results to then only learn if the fetus has a 25% chance of being affected. Because only one maternal sample is needed, these consolidated, and more comprehensive results are available in advance of the critical amniocentesis window. UNITY™ can reduce a patient’s emotional burden caused by awaiting results and limit the logistical burden of separate genetic tests that require multiple blood draws.
UNITY™ is also the only commercially available cfDNA test that offers fetal RhD status (applicable for Rh negative mothers).
From a single blood draw, UNITY™ offers:
- Maternal carrier screening for cystic fibrosis, spinal muscular atrophy, sickle cell disease, thalassemias, and fragile x syndrome (opt in).
- For carriers, automatic fetal screening (via single-gene NIPT or sgNIPT) for these conditions. For fragile X, while we are unable to analyze the number of fetal CGGs using cfDNA due to CGG length, we will provide the fetal sex for all fragile X carriers.
- Fetal screening for aneuploidies including trisomy 21 (Down syndrome), 18 (Edwards syndrome), 13 (Patau syndrome); sex chromosome aneuploidy.
- Fetal sex and fetal RhD status (for Rh negative mothers).
UNITY™ is performed by BillionToOne, a CLIA licensed laboratory. Our test is validated using both preclinical and clinical samples following strict regulations. We have published an analytical validation study and completed a NIH-supported clinical study that includes single-gene NIPT results and outcomes on over 100 clinical samples. Results showed 100% concordance with newborn screening results. Additional clinical studies are pending peer-review, in draft and ongoing. If you would like to learn more, please call 650-460-2551.
Yes, we are validated for carrier screening and NIPT for aneuploidy even with twins. Fetal sexes will be reported if desired and usually we can distinguish fetal sexes between twins.
Fetal RhD is also available in twins.
If a patient is found to be a carrier on our testing, single gene NIPT is NOT validated in a twin pregnancy.