Offering NIPT in your product portfolio

Highly accurate noninvasive prenatal testing results

Resources for NIPT Sendout Labs

If you’re interested in offering noninvasive prenatal testing (NIPT) in your lab as part of your product portfolio, but send the samples to the Illumina CLIA lab for processing, the Verifi Prenatal Test is a great option.

 

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 American College of Medical Genetics and Genomics (ACMG) recommends informing all pregnant people 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 weeks2. The American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal Fetal Medicine (SMFM) have also recommended: "cfDNA screening for common aneuploidies (trisomies 21, 18, and 13) be made routinely available to all obstetrical patients as the most sensitive and specific screening test for common fetal aneuploidies in any patient population. After pretest counseling, every patient has the right to pursue tor decline prenatal genetic screening and diagnostic testing.3

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.

Private payer reimbursement rates and CMS (Centers for Medicare & Medicaid Services) CLFS (Clinical Laboratory Fee Schedule) rates often differ because they are established through different contracting and pricing mechanisms. Private payers negotiate rates individually with laboratories based on market dynamics, while CLFS rates are set by CMS using a weighted median of periodically reported private payer payments under the Protecting Access to Medicare Act (PAMA). 

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 medinfo@illumina.com.

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

Additional Resources

Learn more about the Verifi Prenatal Test

Get details about the Verifi Prenatal Test in one easy-to-read handout, which includes information about test options and performance data, as well as a sample report.

Learn more about the Verifi Plus Prenatal Test

Get the essential information about the broad range of the Verifi Plus Prenatal Test, including specifics on chromosomal aneuploidies identified, and read a sample report.

Choosing the Verifi Plus Prenatal Test

Gain deeper insight into the Verifi Plus Prenatal Test in this brochure, which discusses microdeletions, specific conditions and incidence rates, and offers clinical evidence.

References
  1.   Practice Bulletin 163 Screening for Fetal Aneuploidy (May 2016)
  2.  Dungan JS, Klugman S, Darilek S et al. Noninvasive prenatal screening (NIPS) for fetal chromosome abnormalities in a general-risk population: An evidence-based clinical guideline of the American College of Medical Genetics and Genomics (ACMG). Genet Med. 2023 Feb. 25(2):100336. doi: 10.1016/j.gim.2022.11.004. Epub 2022 Dec 16.
  3. Society for Maternal-Fetal Medicine (SMFM), Rink, B.D., Dugoff, L., Kuller, J.A. and SMFM Publications Committee (2025), Society for Maternal-Fetal Medicine Consult Series #74: Cell-free DNA screening for aneuploidies: Updated guidance. Pregnancy, 1: e70139.https://doi.org/10.1002/pmf2.70139
  4. Practice Bulletin 163 Screening for Fetal Aneuploidy (May 2016)

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.