How can I get UNITY testing?

UNITY is a physician-ordered test. Please call us or email us at support@unityscreen.com so we can help you get the testing done through your OB or midwife. 

Is UNITY covered by my insurance?

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 support@unityscreen.com or call us at 650-460-2551.

How can I order the test?

Please contact your local sales representative or email support@unityscreen.com.  We accept samples from all US states except for New York, Rhode Island, Maryland and Pennsylvania.

Is UNITY available for international markets?

Our laboratory will be ready to receive international samples in late 2019. Please contact support@unityscreen.com for more details.

Is UNITY covered by insurance?

We accept all forms on insurance including Medicaid. UNITY is a carrier screening test first. We bill using existing CPT codes for carrier screening. These CPT codes are covered by Medicaid and all major payers for every pregnant women regardless of their ethnicity. Financial assistance and affordable cash-price are available upon request. For additional billing questions, please contact us at support@unityscreen.com 

Is UNITY right for me?

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 support@unityscreen.com or 650-460-2551.

Does UNITY cover non-invasive prenatal testing for down syndrome and other aneuploidies?

UNITY currently does not cover aneuploidies such as down syndrome. UNITY is an alternative carrier screening test. We assess fetus's risk for cystic fibrosis, spinal muscular atrophy, and hemoglonopathies in addition to testing mother's carrier status for these genetic conditions.

Is your test validated using clinical samples?

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 40 samples, and we were able to show 100% concordance with the newborn screening results https://www.biorxiv.org/content/10.1101/597732v1

How is your test different from non-invasive prenatal tests for Down syndrome?

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.

How is your test different from other carrier screening tests?

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.

What is the minimum gestational age you require for pregnant women?

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. We can perform carrier screening (without single-gene NIPT) on non-pregnant and male samples.

Is UNITY FDA approved?

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.

Is UNITY for every patient?

UNITY is a first-line carrier screen and single-gene NIPT for most pregnant patients. ACOG recommends every pregnant woman is 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.

What is the turnaround time for UNITY?

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

How long does it take to get the result?

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

I have more medical questions. Can I talk to the genetic counselor before taking the test?

Yes, we provide pre-test counseling for free. To schedule an appointment, please call at 650-460-2551 or email us at support@unityscreen.com