Frequently Asked Questions

For Patients

UNITY™ is a physician-ordered test. Please call us or email us at [email protected] so we can help you get the testing done through your OB or midwife.
We accept all insurances including Medicaid. Medical guidelines recommend every pregnant woman to be screened for the disorders covered on UNITY™, therefore, all major private insurance and Medicaid cover the testing. Depending on your insurance details, there may be a co-payment or deductibles you might have to pay. If you have any questions or concerns with testing cost, please email us at [email protected] or call us at 650-460-2551.

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.

UNITY™ currently does not screen for aneuploidies such as Down syndrome. UNITY™ is an alternative carrier screening test. We perform carrier screening for CF, SMA, and hemoglobinopathies and provide single gene NIPT for a fetus at risk for disease.

Most patients get the result within 10 business days since we receive the sample. Please talk to your provider for the test result.

Yes, we provide pre-test counseling for free. To schedule an appointment, please call at 650-460-2551 or email us at [email protected]

For Providers

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.

UNITY™ is a first-line carrier screen and single-gene NIPT for most pregnant patients. ACOG recommends that every pregnant woman be offered screened for cystic fibrosis, spinal muscular atrophy, and hemoglobinopathies. UNITY™ provides this screening AND helps to identify whether a fetus is at risk for disease.

Results are typically available within 10-14 days from the date the sample is received in our lab.