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 an NIPT solution in-house, the VeriSeq NIPT Solution 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 Solution

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

At the beginning of 2017, CMS finalized the 2017 pricing on the three CPT Codes associated with NIPT.

CPT Code Brief Description Final CY 2017
0009M Fetal aneuploidy (trisomy 21, and 18) DNA sequence analysis of selected regions using maternal plasma, algorithm reported as a risk score for each trisomy $602.10
81420 Fetal chromosomal aneuploidy (e.g., trisomy 21, monosomy X) genomic sequence analysis panel, circulating cell-free fetal DNA in maternal blood, must include analysis of chromosomes 13, 18, and 21 $802.33
81422 Fetal chromosomal microdeletion(s) genomic sequence analysis (e.g., DiGeorge syndrome, Cri-du-chat syndrome), circulating cell-free fetal DNA in maternal blood $802.33

Source: 2017 Clinical Laboratory Fee Schedule (CLFS)

Patients with high risk* of fetal aneuploidy are covered by most commercial and public insurance plans in the US. As the clinical guidelines continue to catch up with the emerging technology, some insurance companies, including Anthem Blue Cross Blue Shield and Cigna, have expanded their coverage to all pregnant women and have become the biggest health plans that reimburse NIPT.

The American College of Medical Genetics and Genomics (ACMG) recommends informing all pregnant women that NIPT is the most sensitive screening option for traditionally screened aneuploidies 13, 18 and 21 for a continuum of gestational age beginning at 9–10 weeks. The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal Fetal Medicine (SMFM) have also recommended: "All women should be offered the option of aneuploidy screening or diagnostic testing for fetal genetic disorders, regardless of maternal age. The choice of screening test is affected by many factors, including a desire for information before delivery, prior obstetric history, family history, and the number of fetuses. No one test is superior for all test characteristics and not every test is available at all centers."

*According to the guidelines1 by ACOG and SMFM, high risk is associated with the following:

  • Maternal age ≥ 35yo
  • Parental translocation of chromosomes
  • A previous child with a trisomy
  • Significant ultrasound findings
  • Positive screening test results

Depending on the location of your practice and access to health plans, please consult with your insurance plan administrators on whether your patient is eligible for NIPT coverage.

1.Practice Bulletin 163 Screening for Fetal Aneuploidy (May 2016)

Reimbursement rates for NIPT vary among insurance plans due to contracts. NIPT list prices range from under $1,000 to more than $2,000 per test. Studies found that utilizing NIPT as a first-line screen becomes cost effective at a price of $619–7441-3, with the majority of this value derived from screening for trisomy 213. NIPT is cost-saving when used in the general pregnancy population.

1.Benn P, Curnow KJ, Chapman S, Michalopoulos SN, Hornberger J, Rabinowitz M. An Economic Analysis of Cell-Free DNA Non-Invasive Prenatal Testing in the US General Pregnancy Population. PLoS One. 2015;10(7):e0132313.
2.Fairbrother G, Burigo J, Sharon T, Song K. Prenatal screening for fetal aneuploidies with cell-free DNA in the general pregnancy population: a cost-effectiveness analysis. J Matern Fetal Neonatal Med. 2016;29(7):1160-1164.
3.Walker BS, Nelson RE, Jackson BR, Grenache DG, Ashwood ER, Schmidt RL. A Cost-Effectiveness Analysis of First Trimester Non-Invasive Prenatal Screening for Fetal Trisomies in the United States. PLoS One. 2015;10(7):e0131402.

Since the beginning of NIPT development, over 60 publications have been generated and published by clinical and technical experts and medical societies. To help you and your colleagues make a decision more easily, we have summarized the currently available studies, guidelines, and bibliography in the clinical dossier that you can download and review.

For more information on NIPT reimbursement, please email us at NIPTreimbursement@illumina.com.

Offering the Verifi Prenatal Test in Your Lab

Interested in becoming a select national laboratory partner?

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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.