FAQs

Is your test available for order?

The test is expected to be available for commercial order in June 2019.

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 your test available in New York State?

Our test is currently not available in New York State.

Can I order the single-gene NIPT portion of the test only?

UNITY is a combined carrier screen and single-gene NIPT test. We run every sample through a single workflow, which starts with a carrier screening test.

Do you cover conditions that are recommended to be screened for Ashkenazi Jewish, French Canadian, or Cajun descent?

For indivdiuals with Ashkenazi Jewish, French Canadian, Cajun descent, we offer an expanded carrier screening panel of 43 genes. Reflex single-gene NIPT is only available on CF, SMA, sickle cell disease, and alpha- and beta-thalassemia.

Can I use UNITY for non-pregnant female or male patients?

We accept samples from both pregnant and non-pregnant female as well as male patients.

Can I order UNITY for patients who are known to be a carrier for the conditions you cover?

We accept samples from known carrier mothers. If the patient has recently gone through a carrier screening test from another provider and submitted insurance billing for it, there may be an additional expense. Please contact support@unityscreen.com for further assistance.

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 suppor@unityscreen.com 

Is UNITY covered by Medicaid?

UNITY accepts all Medicaid programs. For additional billing questions, please contact us at support@unityscreen.com.

What is the price of the test for international samples?

Our vision is to make the cutting-edge molecular testing affordable and assessible for everyone around the world. Please contact billing@unityscreen.com for more details on pricing.

What is the out-of-pocket price or cash-pay price for my patient?

Our billing team works closely with every clinic and patient to make the UNITY test as affordable as possible. Please contact billing@unityscreen.com for further assistance.

Who should I reach out to for more billing related questions?

Please contact us at billing@billiontoone.com or call us at 650-460-2551 for further assistance.

What are the conditions covered on UNITY?

Our standard panel covers cystic fibrosis (CFTR), spinal muscular atrophy (SMN1), sickle cell disease (HBB), beta-thalassemia (HBB), and alpha-thalassemia (HBA1, HBA2) for both carrier screening and single-gene NIPT. For individuals with Ashkenazi Jewish, French Canadian, and Cajun descent, we offer an expanded carrier screen panel (43 genes, NGS panel) with a reflex single-gene NIPT to the 5 conditions listed above. We currently do not offer single-gene NIPT beyond the 5 conditions.

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.

Do you offer expanded carrier screening panel beyond cystic fibrosis, spinal muscular atrophy, and hemoglobinopathies?

For individuals with Ashkenazi Jewish, French Canadian, and Cajun descent, we offer an expanded carrier screen panel (43 genes, NGS panel) with a reflex NIPT for CF, SMA, and hemoglobinopathies. We currently do not offer single-gene NIPT beyond the 5 conditions.

How accurate is your test?

UNITY's single-gene NIPT has >98.5% analytical sensitivity and >99% analytical specificity. 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

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 other single-gene non-invasive prenatal tests in the market?

UNITY is the only single-gene NIPT for CF, SMA, sickle cell disease, and thalassemia that doesn't need paternal DNA. Because UNITY combines carrier screening test with the single-gene NIPT, our test is covered by Medicaid and all major payers.

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.

Do you offer the single-gene NIPT portion of UNITY test for pregnancies achieved through surrogacy or egg donation?

Our single-gene NIPT is currently not available for pregnancies achieved through surrogacy or egg donation. We do perform standard carrier screening on these samples.

Do you offer the single-gene NIPT portion of UNITY test for pregnancies achieved with a sperm donor?

UNITY is a great solution for sperm donor pregnancies. We can assess the fetus's risk for CF, SMA, and hemoglonopathies without the need for the biological father's DNA or blood sample.

Do you offer the single-gene NIPT portion of UNITY for twins or multiple gestations?

Our single-gene NIPT is currently not performed on twin or multiple gestations.

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 a diagnostic test? Can patients make treatment decisions based on UNITY results?

UNITY is a screening test. Diagnostic testing such as CVS or amniocentesis or paternal DNA testing is strongly recommended in fetuses identified at risk for disease. We do not recommend irreversible decisions be made from UNITY alone.

Is UNITY for specific patient population or is it for everyone?

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 (combined carrier screening and single-gene NIPT)?

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

What is the turnaround time for the expanded carrier screen (43 genes)?

Results may take up to 20 business days for expanded carrier screen from the date the sample is received in our lab.

Who can I contact with clinical questions?

We have a team of customer service representatives and genetic counselors available to answer clinical questions. Please contact 650-460-2551 or support@unityscreen.com

Who can I contact with questions about billing?

We have a team of billing specialists available to help. Please contact 650-460-2551 or email us at billing@unityscreen.com.