Frequently Asked Questions

For Providers

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™ combines carrier screening and sgNIPT which provides a tailored risk score for the fetus. sgNIPT is automatically performed for all maternal carriers without requiring a paternal sample or any additional maternal blood. UNITY™ follows ACOG guidelines regarding carrier screening for CF, SMA, alpha thalassemia, beta thalassemia, sickle cell disease and fragile x (opt in). These diseases are A) known to be severe, B) prenatal diagnosis is available, and C) early diagnosis increases life expectancy and quality of life.
As UNITY™ uses diverse and advanced technologies to screen for recessive conditions and aneuploidies, reporting timelines varies based on what is ordered. UNITY™ aneuploidy NIPT results are returned within seven days of lab receipt. Most UNITY™ carrier screen and sgNIPT results are returned within 14 days from lab receipt. If fragile X is ordered, you will receive an additional report(s) shortly after the initial carrier screen result.
BillionToOne developed and utilizes an innovative technology called Quantitative Counting Templates (QCT). This revolutionary technology is combined with next gen sequencing enabling UNITY™ to not only identify mutations affecting the pregnancy but can also quantify how many molecules with a mutation are present.

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.

UNITY™ Complete is designed from the ground up to be the best, first-line of screening for pregnant women in the general population. It follows standard-of-care guidelines set by ACOG. BillionToOne believes every woman should have equal access to high quality testing regardless of their background.
UNITY™ Aneuploidy provides the same high degree of sensitivity and specificity for common chromosome conditions you’ve come to expect from NIPT. ACOG recognizes NIPT is the most accurate screen compared to traditional maternal serum screening reducing false positives and false negatives. BillionToOne developed and utilizes an innovative technology called Spike In’s. This one-of-a-kind molecule is used in every test to help make results clear and ensure confidence in every result.

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.

Please email us at [email protected] or call at 650-460-2551 to set up an account and have kits shipped to you. We accept samples from every state except for New York.
Patients must be at least 10 weeks gestation or greater for aneuploidy and single gene NIPT. Carrier screening alone is available prior to or during pregnancy at any time.
Yes, we accept specimens directly from international laboratories. Please contact [email protected] for more details.