Corporate Banner
Satellite Banner
Molecular & Clinical Diagnostics
Scientific Community
 
Become a Member | Sign in
Home>News>This Article
  News
Return

Verinata Health Publishes Clinical Laboratory Performance Data for verifi® Prenatal Test

Published: Monday, April 29, 2013
Last Updated: Monday, April 29, 2013
Bookmark and Share
Demonstrates verifi® is highly accurate in detecting fetal chromosome abnormalities.

Illumina, Inc. announced that Verinata Health, an Illumina company, has published the first peer-reviewed study of non-invasive prenatal test (NIPT) performance in a clinical laboratory setting. Data collected from the first nine months of commercial availability confirmed that Verinata's verifi® prenatal test was in line with its published clinical validation study published in the May 2012 issue of Obstetrics & Gynecology, the official journal of the American College of Obstetricians and Gynecologists. The verifi® prenatal test analyzes DNA found in a pregnant woman's blood to detect the most common chromosome abnormalities in the fetus.

"Professional societies have encouraged NIPT test providers to publish unbiased commercial performance data in a peer-reviewed journal. This publication demonstrates our commitment to transparency and continuous improvement in the quality and monitoring of our verifi® test in the high risk market," said Dr. Jeffrey Bird, General Manager of Verinata Health. "We are committed to providing customers with the best test performance in the industry with regard to accuracy, rate of test failures, and turnaround time."

Test Results in a Clinical Laboratory Setting

In the study published online today and forthcoming in the June issue of Prenatal Diagnosis, Verinata Health tested 5,974 maternal blood samples. Physicians received results of the verifi® test within an average of 5.1 business days, substantially faster than the industry standard. The test failure rate was 0.7%, the lowest published test failure rate in the industry. A low test failure rate reduces additional blood draws and test result delays.

Of the samples tested, the verifi® test detected aneuploidy in 284 (4.8%) samples, a percentage consistent with the overall aneuploidy detection rate in the high-risk pregnant population. Specifically, the verifi® test detected trisomy 21 (Down syndrome) in 155 (2.6%) samples, trisomy 18 (Edwards syndrome) in 66 (1.1%) samples, trisomy 13 (Patau syndrome) in 19 (0.3%) samples, monosomy X (Turner syndrome) in 40 (0.7%) samples with cystic hygroma, and four cases of double aneuploidy. Follow-up data were available for 245 (86%) samples. For all results where aneuploidy is detected through a verifi® test, Verinata Health recommends follow-up with a diagnostic procedure (amniocentesis or chorionic villus sampling).

Five (0.08%) false negative cases were reported (two cases of trisomy 21, two cases of trisomy 18 and one monosomy X). One of the trisomy 21 cases was recently presented at the 2013 ACMG Annual Clinical Genetics meeting. Additionally, 14 (0.2%) putative false positive sample results from the verifi® test were not consistent with invasive procedure results or live birth outcomes. As described in other case reports, these putative false positives may actually result from complex underlying biological causes.

"Our initial commercial experience published today demonstrates that the accuracy of the verifi® prenatal test is consistent with our large, blinded prospective validation study, and we intend to publish additional performance data as our test volumes continue to increase," commented Richard Rava, Ph.D., Vice President of Research and Development at Verinata.

Product enhancements, corporate partnerships and positive payer coverage decisions continue to drive demand for the verifi® prenatal test. In December 2012, Verinata introduced an expanded test menu that includes sex chromosome abnormalities. In January 2013, Verinata signed an agreement with PerkinElmer, Inc. to expand access to the verifi® prenatal test in the United States.


Further Information

Join For Free

Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 3,500+ scientific posters on ePosters
  • More than 5,000+ scientific videos on LabTube
  • 35 community eNewsletters


Sign In



Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into TechnologyNetworks.com you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Related Content

Verinata Health Announces Agreement with Teva Pharmaceutical Industries
Agreement establishes patient registry for clinical outcomes data.
Tuesday, July 02, 2013
Scientific News
Point of Care Diagnostics - A Cautious Revolution
Advances in molecular biology, coupled with the miniaturization and improved sensitivity of assays and devices in general, have enabled a new wave of point-of-care (POC) or “bedside” diagnostics.
ReadCoor Launched to Commercialize 3D Sequencing Tech
ReadCoor will leverage the Wyss Institute’s method for simultaneously sequencing and mapping RNAs within cells and tissues to advance development of diagnostics.
Crispr Toolbox Expanded By Protein
Researchers have shown a newly discovered CRISPR protein has two distinct RNA cutting activities.
Heart Arrhythmia Caused by Mosaic of Mutant Cells
Researchers have solved the genetic mystery of an infant suffering from heart arrhythmia.
Over Two-Thirds of Cervical Cancer Deaths Prevented
Cervical screening prevents 70% of cervical cancer deaths and if all eligible women regularly attended screening this would rise to 83%.
Detecting Bacterial Infections in Newborns
Researchers tested an alternative way to diagnose bacterial infections in infants—by analyzing RNA biosignatures from a small blood sample.
Case for Liquid Biopsies Builds in Advanced Lung Cancer
Study addresses unmet need for better, non-invasive tests called out in recent "Moonshot" blue ribbon panel report
Mechanisms of Parkinson’s Pathology
Defects that lead to cells’ failure to decommission faulty mitochondria cause nerve cells to die, triggering the symptoms of Parkinson’s disease.
Genetic Misdiagnoses of Heart Condition
Analysis found several genetic variations previously linked with a heart condition were harmless, leading to condition misdiagnosis.
Opening Door to Oesophageal Cancer Targeted Treatments
Scientists have discovered that oesophageal cancer can be classified into three different subtypes.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,500+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
5,000+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!