Verifi Prenatal Test Services

Verifi Prenatal Test Services

Verifi and Verifi Plus Prenatal Tests safely and noninvasively screen for the most common chromosomal aneuploidies as early as 10 weeks gestation using a single maternal blood draw. Verifi offerings provide the latest innovation in sequencing with a fast turnaround time, low failure rate, and accurate results.1

Verifi offers proven superiority to traditional screening methods for the screening of common fetal aneuploidies, with reduced false positive rates (increased specificity) and increased positive predictive values (PPV).1,2 Verifi has the lowest published failure rate in the industry—0.1%.1,3,4 Learn about evaluating test performance metrics for NIPT and view metrics for Verifi.

Physicians can order this Illumina service through our network of partner labs. Samples are processed at our CLIA-certified, CAP-accredited lab within 3-5 days. The physician will receive a report for use in discussing results and next steps with the patient.

The Verifi Prenatal Test is a non-invasive screening option for chromosomes 13, 18, and 21, and fetal sex chromosome aneuploidies in both singleton and twin pregnancies

Highlights:
  • Better than serum screen (fewer false positives)2,5,6
  • Fast turnaround time (3-5 days)
  • Low failure rate and high accuracy1
  • Testing Indications:
    • Advanced maternal age (> 35 years)
    • Positive serum screen
    • Abnormal ultrasound
    • History suggestive of increased risk for the specified chromosome aneuploidies
    • Low risk/maternal anxiety
    Screens for:
    • Trisomy 21 (Down syndrome)
    • Trisomy 18 (Edwards syndrome)
    • Trisomy 13 (Patau syndrome)
    • Fetal sex aneuploidies

    The Verifi Plus Prenatal Test contains everything in the Verifi Prenatal Test and includes additional panels. It is a non-invasive screening option for standard chromosome aneuploidies, certain microdeletions, and all autosomes. Expanded panels (microdeletions or all autosomes) are optional add-ons for singleton pregnancies.

    Highlights:

    Verifi Plus screens for more chromosome conditions than Verifi.

    Testing Indications:

    Women who decline an invasive procedure in the presence of an abnormal ultrasound.

    Available Optional Add-On Offerings Include:
    • Sex chromosome aneuploidies
      • Monosomy X (MX; Turner syndrome)
      • XXX (Triple X)
      • XXY (Klinefelter syndrome)
      • XYY (Jacobs syndrome)
    • Expanded autosomal trisomies
      • All chromosomes
    • Microdeletion syndromes
      • 1p36 deletion
      • 4p- (Wolf-Hirschhorn syndrome)
      • 5p- (cri-du-chat syndrome)
      • 15q11 (Prader-Willi syndrome/Angelman syndrome)
      • 22q11 deletion (DiGeorge)

    Contact Illumina services at verifiglobal@illumina.com for regional availability.

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    References
    1. Taneja PA, Snyder HL, de Feo E, et al. Noninvasive prenatal testing in the general obstetric population: clinical performance and counseling considerations in over 85 000 cases. Prenat Diagn. 2016;36(3):237-243.
    2. Bianchi DW, Parker RL, Wentworth J, et al. DNA sequencing versus standard prenatal aneuploidy screening. N Engl J Med. 2014;370(9):799-808.
    3. McCullough RM, Almasri EA, Guan X, et al. Non-invasive prenatal chromosomal aneuploidy testing--clinical experience: 100,000 clinical samples. PLoS One. 2014;9(10):e109173.
    4. Ryan A, Hunkapiller N, Banjevic M, et al. Validation of an enhanced version of a single-nucleotide polymorphism-based noninvasive prenatal test for detection of fetal aneuploidies. Fetal Diagn Ther. 2016;40(3):219-223.
    5. Gregg AR, Skotko BG, Benkendorf JL, et al. Noninvasive prenatal screening for fetal aneuploidy, 2016 update: a position statement of the American College of Medical Genetics and Genomics. Genet Med. 2016;18(10):1056-1065.
    6. 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. (VHI), 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.