FAQs

Frequently Asked Questions

For Providers

UNITY™ is designed to be the best first-line screening for all pregnant women in the general population.  Attention was given to every step of the process, from no charge pre-test genetic counseling and tests covered by most insurances, including Medicaid, to accessible financial assistance programs.

UNITY™ Complete provides the most in-depth results in a single test for pregnant women and includes an important fetal risk assessment for single-gene disorders if mom is found to be a carrier. No other testing on the market can give patients the level of detail they get in UNITY™ Complete and it’s the only commercial test that includes fetal RhD status if desired.

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™ Complete includes three tests: 

1) Non-invasive prenatal testing (NIPT) for Down syndrome, Trisomy 18, Trisomy 13, and sex chromosome aneuploidy such as Turner syndrome. Fetal sex is available and we are validated in twin gestations.

2) Carrier screening with automatic reflex to single gene NIPT if the patient is found to be a carrier. This is the only test to provide a fetal risk assessment reducing the time to make a diagnosis and does NOT require testing for the partner.

3) Fetal Rh D status is available as an add on for Rh negative mothers. This testing is included with screening for aneuploidy. Fetal RhD status is available after a report is completed even it was not initially ordered. Please contact us at 650-460-2551 for an updated report.

UNITY™ combines carrier screening and a single-gene NIPT (sgNIPT) which provides a risk assessment for the pregnancy to be affected. When a mother tests positive as a carrier, sgNIPT is automatically performed without requiring additional blood. The testing does NOT require a sample from the father of the pregnancy.

UNITY™ drastically reduces the time to make a diagnosis which has clear benefits and because it does NOT require testing on the patient’s partner, UNITY™ identifies a much higher percentage of truly affected pregnancies compared to traditional carrier screening.

UNITY™ follows ACOG guidelines regarding carrier screening for CF, SMA, alpha thalassemia, beta thalassemia, and sickle cell disease. These diseases are: A) known to be serious, B) prenatal diagnosis is available, and C) early diagnosis increases life expectancy and quality of life.

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.

Results include carrier screening on the patient and fetal risk assessment through single-gene NIPT when applicable. They are typically available within 14 days from when the lab receives the sample from their provider.
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.