Offering NIPT in your product portfolio

Highly accurate noninvasive prenatal testing results

NIPT for Clinical Labs

If you’re interested in offering noninvasive prenatal testing (NIPT) in your lab, we have 2 product offerings: an in-house solution and out-of-lab solution. For labs that want to bring a software solution in-house, the VeriSeq NIPT Analysis Software (16 Samples) is a EU CE marked in vitro diagnostic product and is now available in certain European Union countries. For those that want to offer NIPT as part of their product portfolio, but send the samples to the Illumina CLIA lab for processing, the verifi Prenatal Test is a great option.

Learn more about the VeriSeq NIPT Analysis Software

The forefront of prenatal screening

How the Process Works

Our verifi NIPT service makes the process seamless – from sample to answer.

Test requisition/signed consent form and blood sample are obtained.

Blood sample and test request form are sent back to lab.

Lab processes and analyzes the sample.

The lab reports test results.

The verifi test screens for trisomies 21, 18 and 13. There is an option for sex chromosome aneuploidy (Monosomy X, XXX, XXY, XYY), fetal sex (XX or XY), and selected microdeletions as well.
Test reports will include one of three possible results for chromosomes 21, 18, and 13: “No Aneuploidy Detected”, “Aneuploidy Detected”, or “Aneuploidy Suspected (Borderline Value)”.
  • “No Aneuploidy Detected” — This result is reassuring, but does not guarantee an unaffected pregnancy.
  • “Aneuploidy Detected” — This result indicates an increased likelihood of the fetus being affected. There is a chance however, that the result does not reflect the chromosomes of the fetus.
  • “Aneuploidy Suspected (Borderline Value)” — This result gives an indication that although there is a higher risk for fetal aneuploidy than a “No Aneuploidy Detected” result, the chances of a false positive are somewhat greater than the results in the “Aneuploidy Detected” zone.
Per the American College of Obstetricians and Gynecologists (ACOG), if a screening result is positive (aneuploidy detected or suspected), further counseling and a diagnostic test (e.g. chorionic villus sampling or amniocentesis) should be offered.1
For singleton pregnancies, sex chromosome results are reported in cases where requested. If there are no sex chromosome aneuploidies, the report will indicate XX or XY status. The health care professional and patient will decide if the fetal sex information is revealed to the patient.
Offering the verifi Prenatal Test in Your Lab

Interested in becoming a select national laboratory partner?

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Offering the verifi Prenatal Test in Your Lab
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References
  1. Practice Bulletin No. 163: Screening for Fetal Aneuploidy. Obstet Gynecol. 2016;127(5):979-981.

The verifi Prenatal Test was developed by, and its performance characteristics were determined by Verinata Health, Inc. a wholly owned subsidiary of Illumina, Inc. The VHI laboratory is CAP-accredited and certified under the Clinical Laboratory Improvement Amendments (CLIA) as qualified to perform high complexity clinical laboratory testing. It has not been cleared or approved by the U.S. Food and Drug Administration.