The Only Carrier Screen with Reflex Single-Gene NIPT for

  • cystic fibrosis
  • spinal muscular atrophy
  • sickle cell disease
  • alpha thalassemia
  • beta thalassemia

Why UNITYTM ?

It is the only single-gene, NIPT-supported carrier screening panel that uses a single sample of the mother’s blood 1 to determine her carrier status and fetal risk for all ACOG-recommended inherited disorders.

UNITYTM
vs
Traditional Carrier Screening

Testing Method

Carrier Screen
+ Reflex Single-Gene NIPT
Carrier Screen

Blood Sample

Requirement
maternal only regardless of carrier status findings
maternal + paternal if mother is found to be carrier

Fetal Risk

assessment included

Positive Test Result Rate

< 1%
11% for maternal test

System-Level PPV

% affected fetus among women with positive result
98.5+%
~50% <50% paternal DNA follow-up rate

System Turnaround Time

2 weeks
4-8 weeks maternal + parental testing

Total Cost

single fee
multiple fees paternal testing often not covered by insurance
Who is UNITYTM for?

UNITYTM covers carrier screening for all ACOG-recommended conditions

UNITYTM provides carrier screening for pregnant and non-pregnant samples from female and male patients. Reflex single-gene NIPT2 is available for ACOG-recommended disorders:

  • Cystic fibrosis (CFTR)
  • Spinal muscular atrophy (SMN1)
  • Sickle cell disease (HBB)
  • Alpha and beta-thalassemia (HBA1, HBA2, HBB)

In addition, expanded carrier screening (43 genes, NGS panel) is available for individuals of Ashkenazi Jewish, French Canadian, and Cajun descent. 2

In addition to existing guidance recommending universal screening for cystic fibrosis, all women should also be offered screening for spinal muscular atrophy (SMA). ACOG committee opinion 691, issued March 2017

UNITYTM: ACCURACY YOU CAN COUNT ON

98.5+% sensitivity

99+% specificity 2

  • Carrier screening portion of UNITY is NGS based and meets the highest industry standards. We perform full gene sequencing on CFTR. We detect SMN1 silent carrier.
  • NIPT portion of UNITY has >98.5% analytical sensitivity and >99% specificity.

100% accuracy in two clinical trials 2

  • At a NIH-funded study with Baylor College of Medicine4, 40+ samples processed revealed “high risk” cases. Newborn screening confirmed all NIPT calls were correct.
  • At a joint study with Yashoda Hospital in India, 200+ samples were processed and 27 “high risk” pregnancies were identified. Testing after birth confirmed all NIPT calls were correct.

How UNITYTM works2

UNITYTM performs carrier testing on the pregnant mother using next-generation sequencing followed by confirmatory Sanger sequencing. For copy number variations, especially in SMA and alpha-thalassemia, digital MLPA is performed. If the result is positive, cell-free DNA is analyzed for the number of molecules with mutations and those without mutations by transforming next- generation sequencing data to digital molecular counts. BillionToOne is the only NIPT provider for detecting recessive conditions without requiring paternal DNA.

UNITYTM IN YOUR PRACTICE

  • STEP 1
    order
    Order UNITYTM
    Online order via EMR system available.
  • STEP 2
    collect
    Collect Blood Sample
    Collect just one tube of maternal blood. We perform carrier screening and reflex single-gene NIPT from a single blood sample.1
  • STEP 3
    ship sample
    Ship Sample
    Ship the sample using pre-labeled kit.
  • STEP 4
    results
    Receive Results in 2 Weeks
    Results sent to physician within 2 weeks. Access test results online.
  • STEP 5
    access counseling
    Access Complimentary Genetic Counseling
    Complimentary genetic counseling sessions are available for all patients.

Frequently Asked Questions

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 suppor@unityscreen.com 

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 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.

Connect With Us

UNITYTM is available to limited number of clinics through Early Access Program. Contact us to learn more.

Clinician Resources

Index Card

Index Card

Brochure (Clinicians)

Brochure

Report (Neg)

Sample Report

Negative
Report (Pos + Low)

Sample Report

Positive Carrier, Low Risk Fetus
Report (Pos + High)

Sample Report

Positive Carrier, High Risk Fetus
Requisition Form (5-Gene)

Requisition Form

Regular Panel (5-Gene)
Requisition Form (43-Gene)

Requisition Form

Ashkenazi-Jewish / French Canadian / Cajun Panel (43-Gene)
  1. Small number of cases require a secondary draw, which include when the gestational age is under 10 weeks, the fetal fraction is less than 5%, or when the test is inconclusive
  2. Tsao et al., 2019 “A novel high-throughput molecular counting method with single base-pair resolution enables accurate single-gene NIPT” [Preprint]
  3. Offered to Ashkenazi Jewish, French Canadian, or Cajun decent only. Reflex single-gene NIPT on Ashkenazi Jewish specific genes is currently not available
  4. Funded by the National Heart, Lung, and Blood Institute of the National Institute of Health under award number R43HL144322