providers-headline

verifi® Prenatal Test

Verinata Health, Inc. 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
  • COMPREHENSIVE — Capable of aneuploidy detection across the genome

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 (Trisomy X)
  • XXY (Klinefelter syndrome)
  • XYY (Jacob’s 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 Performance*

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

Chr 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.

Chr 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).

*Test performance data on file.

Intended Use

For patients at 10+ weeks gestation with singleton pregnancies who meet any of the following criteria:

  • Advanced maternal age
  • Positive results of prenatal aneuploidy screening
  • Presence of ultrasound abnormalities
  • Previous affected pregnancy for fetal aneuploidy
Most Offerings