Sema4 Elements™

Noninvasive Prenatal Select

 

Accurate insight into fetal health as early as 9 weeks gestation

Sema4 Elements™ Noninvasive Prenatal Testing (NIPT) analyzes genetic information of cell-free DNA (cfDNA) through a simple maternal blood draw to determine the risk for common aneuploidies, sex chromosomal abnormalities, and microdeletions, in addition to fetal gender, as early as nine weeks gestation.

The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recommend that all pregnant women are offered screening or diagnostic testing for fetal aneuploidy.

 

Highly accurate screening for chromosomal abnormalities

Our test uses paired-end next-generation sequencing technology to provide higher depth across targeted regions. It also uses a laboratory-specific statistical model to help reduce false positive and false negative rates.

The test can be offered to all women with:
singleton    twins    triplet pregnancies, including egg donor

Sema4 Elements Noninvasive Prenatal Testing (NIPT)

screens for common chromosome aneuploidies, sex chromosome aneuploidies, and microdeletion syndromes, with the flexibility to order select components of the test

Gestational age
9+ weeks
Turnaround time
~7 days
Min. fetal fraction required
2%
Low failure rate
<1%*
Option to include Trisomies 15, 16 and 22
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Option to include Microdeletions
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Multiple gestational pregnancies
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MPSS counting-based methodology
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No restrictions for egg donors and surrogates
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High specificity & sensitivity for common autosomal and sex chromosome aneuploidies
>99%
Fetal sex accuracy
>99%

Performance of the Newly Developed Noninvasive Prenatal Testing. [White Paper]. Sema4 (2019).
*Rate applies to failures due to low fetal fraction; other causes of test failures may also occur (i.e. early gestational age, ​delayed shipment, failed QC, etc).

 

Potential clinical benefits of low failure rates

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Reduce the need for redraws
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Limit unnecessary invasive procedures
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Reduce overall time required to obtain reliable results

 

Sema4 Noninvasive Prenatal Select offers flexible testing

Standard
(-SCAs)
Trisomy 21
Trisomy 18
Trisomy 13
Fetal sex
Standard
(+SCAs)
Trisomy 21
Trisomy 18
Trisomy 13
Sex chromosome aneuploidies:
X
XXX
XXY
XYY
Fetal sex
Standard
Plus
Trisomy 21
Trisomy 18
Trisomy 13
Sex chromosome aneuploidies:
X
XXX
XXY
XYY
Trisomy 15
Trisomy 16
Trisomy 22
Fetal sex
Expanded
Trisomy 21
Trisomy 18
Trisomy 13
Sex chromosome aneuploidies:
X
XXX
XXY
XYY
Trisomy 15
Trisomy 16
Trisomy 22

Microdeletions:

22q11.2
1p36
4p16
5p15
15q11.2-q13
8q24
11q23

Fetal sex
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Turnaround time

Fast turnaround time, with results available in about 1 week

Support for your practice and patients

Our CLIA-certified lab offers comprehensive prenatal testing

  • Screening with Noninvasive Prenatal Testing is available for singleton pregnancies and pregnancies using an oocyte donor, sperm donor, or gestational carrier
  • Prenatal diagnostic testing, including chromosome analysis, aneuploidy FISH, or chromosomal microarray, may be ordered directly from Sema4 to confirm positive NIPT results. Diagnostic testing is available through chorionic villus sampling (CVS) at 10 to 12 weeks of pregnancy and amniocentesis after 15 weeks of pregnancy
  • Carrier screening, maternal serum screening, and noninvasive prenatal testing for multiple
    gestation pregnancies are also available

Educational resources and genetic counseling to help support patients during testing

Before testing

  • An educational video helps patients learn more about the role of noninvasive prenatal screening

After results are received

  • Genetic counselors are available to offer guidance and support for patients with positive results
  • Patients who screen negative can access educational videos to learn more about their results and discover fetal sex, if desired

CLIA=Clinical Laboratory Improvement Amendments; FISH=Fluorescence in situ hybridization

Resources

 

Start the Journey with Us

Kindly fill out the form below and we’ll schedule a time to discuss your needs. Or feel free to call us at 800-298-6470.