verifi® prenatal test

Illumina is proud to offer the verifi® prenatal test—a non-invasive prenatal test that detects multiple fetal chromosomal aneuploidies using a single maternal blood draw with near-diagnostic accuracy. If you have ever wanted safer, simpler test results or wished to screen at 10 weeks instead of waiting, now you can order the verifi® prenatal test.

Continuous innovation

Increased safety and peace of mind for your patients

Swift acceptance of the verifi® prenatal test has made a world of difference to high-risk patients across the country:

  • SAFE—Routine blood draw, just one tube (7-10 ml)
  • ACCURATE—Directly analyzes cell-free fetal DNA with our proprietary SAFeR™ algorithm
  • EASY—Test as early as 10 weeks, no limitations in reference to patient ethnicity, BMI, ART, or egg donor cases
  • FAST—Results reported in 3-6 business days after sample receipt

The basic verifi® test detects:

  • T21 (Down syndrome)
  • T18 (Edwards syndrome)
  • T13 (Patau syndrome)

Now a wider option is available for sex chromosomes at no extra charge:

  • Monosomy X (MX; Turner syndrome)
  • XXX (Triple X)
  • XXY (Klinefelter syndrome)
  • XYY (Jacobs syndrome)
  • Fetal sex (XX or XY)—aids in stratifying the risk for X-linked disorders such as hemophilia, Duchenne muscular dystrophy, or cases of ambiguous genitalia, such as congenital adrenal hyperplasia

Test performance1

As sequencing technology rapidly evolves, our research team has analyzed and implemented several changes to the testing procedure that yield enhanced test performance.

N Sensitivity 95% CI Specificity 95% CI
21 500 >99.9% (90/90) 96-100.0 99.8% (409/410) 98.7-100.0
18 501 97.4% (37/38) 86.2-99.9 99.6% (461/463) 98.5-100.0
13 501 87.5% (14/16) 61.7-98.5 >99.9% (485/485) 99.2-100.0
Both “Aneuploidy Detected” and “Aneuploidy Suspected (Borderline Value)” results were included for performance calculation.
MX 508 95.0% (19/20) 75.1-99.9 99.0% (483/488) 97.6-99.7

The verifi® test now includes an option for the most common sex aneuploidies, providing information previously known only through invasive results.

N Sensitivity 95% CI Specificity 95% CI Accuracy 95% CI
XX 508 97.6% (243/249) 94.8-99.1 99.2% (257/259) 97.2-99.9 98.4% 96.9-99.3
XY 508 99.1% (227/229) 96.9-99.9 98.9% (276/279) 96.9-99.8 99.0% 97.7-99.7
XXX
XXY
XYY
Limited data of these more rare aneuploidies preclude performance calculations.
Sex chromosome mosaicism cannot be distinguished by this method (the occurrence of which is <0.3%). Patients with such mosaicism will have a sex chromosome result reported and will fall into one of the six categories (Monosomy X, XXX, XXY, XYY, XX, XY).

Reference

  1. Verinata Health, Inc. (2012) Analytical Validation of the verifi® Prenatal Test: Enhanced Test Performance For Detecting Trisomies 21, 18 and 13 and the Option for Classification of Sex Chromosome Status. Redwood City, CA.

Intended use

This screening test is intended for patients at 10 weeks or greater gestation who meet any of the following criteria:

  • Advanced maternal age (≥35 years at delivery)
  • Positive serum test
  • Abnormal ultrasound
  • History suggestive of increased risk for T21, T18, T13, or sex chromosome aneuploidy

Get started!

Our Client Services group is on site and readily available along with certified genetic counselors to provide knowledgeable, timely support.

Call Illumina at: (855) 266-6563