Frequently Asked Questions
American College of Obstetricians and Gynecologists (medical society for OBGYNs) recommends every pregnant woman to be screened for these disorders.
UNITY™ screens for commonly inherited disorders: 1 in 25 Northern Europeans are carrier for cystic fibrosis. 1 in 8 African Americans are carrier for sickle cell disease. 1 in 54 men and women worldwide are carrier for Spinal Muscular Atrophy.
If you are a Ashkenazi Jewish, French Canadian, or Cajun decent, we recommend you consider our expanded carrier screening panel. Please ask your doctor or reach out to us for more questions at [email protected] or 650-460-2551.
Most patients get the result within 10 business days since we receive the sample. Please talk to your provider for the test result.
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 100 samples, and we were able to show 100% concordance with the newborn screening results.
Please contact your local sales representative or email [email protected]. We accept samples from all US states except for New York.
Yes, we accept send-out specimens from international laboratories. Please contact [email protected] for more details.
UNITY™ Complete covers Down syndrome (trisomy 21), trisomy 13, trisomy 18 and sex chromosome aneuploidies in addition to the UNITY™ carrier screen conditions. Fetal RhD is also available as an add on test for Rh negative mothers.
UNITY™ is a combined carrier screen and single-gene non-invasive prenatal test. When a mother tests positive as a carrier, we automatically reflex to single-gene NIPT without requiring any additional blood sample from the mother or father. We are the only carrier screening provider with a reflex single-gene NIPT, that’s covered by insurance.
Pregnant patients must be at least 10 weeks gestation for the single-gene NIPT portion of the test. We request a sample redraw if the patient’s blood is drawn prior to 10 weeks gestation. single-gene NIPT is also not available for twin pregnancies. We can perform carrier screening (without single-gene NIPT) on non-pregnant and male samples as well as twin-pregnancies.
UNITY™ is offered by BillionToOne, a laboratory that is under the purview of the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. UNITY™ does not fall under the approval/guidance of US Food and Drug Administration.
Results are typically available within 10-14 days from the date the sample is received in our lab.