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.

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
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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.

Connect With Us

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

  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