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Verifi - Non Invasive Prenatal Testing

Verifi - Non Invasive Prenatal Testing

We proudly offer Illumina's 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 SAFeRalgorithm
  • 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)
  • T9 (optional, no extra charge)
  • T16 (optional, no extra charge)

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 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).

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.

 

The verifi® microdeletion panel identifies 6 important genetic syndromes

Thanks to Illumina's superior technology, verifi can now detect 6 important genetic syndromes:

  • DiGeorge Syndrome
  • 1p36 deletion Syndrome
  • Angelman Syndrome*
  • Prader-Willi Syndrome*
  • Cri du Chat Syndrome
  • Wolf-Hirschhorn Syndrome

*The microdeletion region is the same region for Angelman and Prader-Willi syndromes (15q11.2). NIPT will not distinguish between these two syndromes. Further testing is necessary.

The verifi® Prenatal Test for Twins 

Screening for fetal aneuploidy in twin gestations poses unique challenges such as lower levels of DNA available for analysis from each fetus. By expanding the sensitivity and overall capability to detect aneuploidies, we are now able to offer the verifi® prenatal test for twins!

The verifi® test for twins screens for:

  • Trisomy 21 (Down syndrome)
  • Trisomy 18 (Edwards syndrome)
  • Trisomy 13 (Patau syndrome)
  • Presence of Y (optional)

The verifi® option can be used with both monozygotic and dizygotic cases.

 

The Twins Option — Improved Algorithm To Evaluate Risk

Innovative developments in workflow and bioinformatics have led to an increased number of sequencing reads per sample and improved the accuracy of classifying aneuploidy affected samples.

Using our improved algorithm to analyze 115 maternal plasma samples from twin pregnancies, the twins option correctly detected:1

  • 3/3 cases with Trisomy 21 present in one twin
  • 1/1 case with Trisomy 18 present in both twins (monochorionic)
  • 91/91 cases with at least one male twin
  • No false positives

By extending the capabilities of the SAFeR algorithm, the verifi® test can analyze complex twin cases with no increase in turn-around time or cost.

 

Easy to Use

  • Ship sample and requisition to Verinata
  • Results reported in 3–6 business days via mail, online portal, or fax
  • Aneuploid results:
    Verinata genetic counselors contact provider
 

verifi® Prenatal Test Benefits For Clinicians

Key strengths that make the verifi® test the first choice among healthcare professionals:

  • Fastest Turnaround Time: Results reported 3–6 business days from sample receipt.
  • Lowest Failure Rate: 0.07%3
  • Only 1 Tube of Blood Needed (7–10 mL)
  • In-house Genetic Counselors: Provide proactive support to clinicians.

1Verinata Health, Inc. (2013) Accurate Aneuploidy Detection in Twin Pregnancies With an Optimized Algorithm for the verifi® Prenatal Test. Redwood City, CA.
2Canick J, Koza E, et al. DNA sequencing of maternal plasma to identify Down syndrome and other trisomies in multiple gestations. Prenat Diagn 2012;32:1–5.
3Data on file.

Category
Department
Medical specialty
Required sample
Peripheral Blood (EDTA)
Quantity
Turn around time
7-9 days
Technology
Massive Parallel Sequencing