Clinical Diagnostics

verifi® by Retrogen Non-Invasive Prenatal Testing

The verifi® Prenatal test represents a major advance in prenatal testing, providing accurate answers about fetal chromosomal health without the risk associated with invasive procedures, such as amniocentesis or chorionic villis sampling (CVS).

 

verifi® Prenatal Test is a noninvasive prenatal screening that screens for multiple fetal chromosomal aneuploidies using a single maternal blood draw with high sensitivity and specificity. verifi® by Retrogen accurately detects aneuploidies: trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), and trisomy 13 (Patau syndrome).

 

verifi® Prenatal Testing is:

  • Safe-Routine, noninvasive blood draw, just one tube (7-10 ml)
  • Accurate-Directly analyzes cell-free fetal and maternal DNA with our proprietary SAFeRTM algorithm; very low failure rate (0.1%)
  • Easy-Test as early as 10 weeks gestational age (8 weeks of fetal age as determined by date of conception). No limitations regarding ethnicity, BMI, ART or egg donor cases.
  • Fast-Results reported to partner laboratory in 3 - 5 business days after sample receipt. (Time to report may vary based on partner laboratory providing the test.)

 

In comparison to other screening options, noninvasive prenatal testing provides more reliable results with a higher positive predictive value than traditional serum screens, and does not carry the risk of complications that an invasive procedure can have.

Available Tests


Non-Invasive Prenatal Testing

Documents
NIPT Patient Information Sheet  NIPT Provider Information Sheet 
NIPT Requisition Form 
Test Information
Genes: Chromosomes 21, 18, 13
Clinical Utility: Detection of aneuploidies
Method:  
Ordering
Test ID: #8001 verifi® Non-Invasive Prenatal Test
Turn-around Time: 4-6 business days after sample receipt
Preferred Specimen: 7-10 ml of venous blood
Billing
CPT Codes: 81507
Billing Information: View Billing Information
References
  1. ACOG Committee on Practice Bulletins. ACOG Practice Bulletin No. 77: screening for fetal chromosomal abnormalities. Obstet Gynecol. 2007:109:217-227.
  2. American College of Obstetricians and Gynecologists Committee on Genetics. Committee Opinion No. 545: noninvasive prenatal testing for fetal aneuploidy. Obstet Gynecol. 2012:120:1532-1534.
  3. Gregg AR, Gross SJ, Best RG, et al. ACMG statement on noninvasive prenatal screening for fetal aneuploidy. Genet Med. 2013:15:395-398.
  4. Benn P, Borell A, Chiu R, et al. Position Statement from the Aneuploidy Screening Committee on Behalf of the Board of the International Society for Prenatal Diagnosis. Prenat Diagn. 2013;33:622-629.
  5. Devers PL, Cronister A, Ormond KE, Facio F, Brasington CK, Flodman P. Noninvasive prenatal testing/noninvasive prenatal diagnosis: the position of the National Society of Genetic Counselors. J Genet Couns. 2013:22:291-295.
  6. Bhatt S, Parsa S, Snyder H, Taneja P, Halks-Miller M, Seltzer W, DeFeo E. Clinical Laboratory Experience with Noninvasive Prenatal Testing: Update on Clinically Relevant Metrics. ISPD 2014 poster.
  7. Verinata Health, Inc. (2012) Analytical Validation of the XXX Prenatal Test: Enhanced Test Performance For Detecting Trisomies 21, 18 and 13 and the Option for Classification of Sex Chromosome Status. Redwood City, CA.
  8. Futch T, Spinosa J, Bhatt S, de Feo E, Rava RP, Sehnert AJ. Initial clinical laboratory experience in noninvasive prenatal testing for fetal aneuploidy from maternal plasma DNA samples. Prenat Diagn. 2013:33:569-574.
  9. Data on file: Internal data from lab metric updates.
  10. Norton ME, Brar H, Weiss J, et al. Noninvasive chromosomal evaluation (NICE) study: results of a multicenter prospective cohort study for detection of fetal trisomy 21 and trisomy 18. Am J Obstet Gynecol. 2012;207:137.e1-8.
  11. Pergament E, Cuckle H, Zimmermann B, et al. Single-nucleotide polymorphism-based noninvasive prenatal screening in a high-risk and low-risk cohort. Obstet Gynecol. 2014;124:210-218.