REDWOOD CITY, Calif., April 25, 2012 /PRNewswire/ -- Verinata Health, Inc., a privately-held company dedicated to maternal and fetal health, today announced the peer-reviewed publication of a new health economic model for its verifi™ prenatal test that clearly demonstrates the clinical and economic value of integrating the verifi™ prenatal test into current prenatal screening algorithms. The model shows a dramatic reduction in both the number and cost of invasive procedures and associated miscarriages. This is the largest and most comprehensive health economic model to date evaluating the clinical and cost impact of incorporating a non-invasive prenatal test into routine clinical practice for high-risk pregnancies.
The model demonstrates, for a theoretical population of 100,000 pregnancies in five million covered lives, that incorporating the verifi™ test as a secondary prenatal screening test for high-risk pregnancies can be accomplished without an increase in the overall cost of care. The model also illustrates that clinical benefit is realized through the significant reduction in false positive results. Specifically, to correctly diagnose one aneuploidy, incorporating the verifi™ test into clinical practice for high-risk pregnancies would decrease the number of invasive diagnostic procedures by 81 percent, corresponding to a 71 percent reduction of costs associated with these procedures. Additionally, the model shows that unintended miscarriages due to invasive testing would be reduced from 60 with standard of care to 20 using the verifi™ test, a 66 percent reduction.
The publication, authored by Dr. Susan S. Garfield and Shannon Armstrong of Bridgehead International, is now available in the April edition of The Journal of Managed Care Medicine and online at http://www.namcp.org/mainjournalpage.htm. The publication is titled, "Clinical and Cost Consequences of Incorporating a Novel Non-Invasive Prenatal Test into the Diagnostic Pathway for Fetal Trisomies."
"This model demonstrates that the greatest clinical benefits of incorporating the verifi™ test into clinical practice are the reductions in invasive testing and unintended miscarriages, by 72 and 66 percent respectively," said Dr. Garfield. "The model also suggests that tests with the highest sensitivity and specificity, such as the verifi™ prenatal test, will have the most positive economic impact to payers by decreasing false positive rates and associated unnecessary follow-up costs for invasive tests by 71 percent. These economic savings can be considered alongside the significant decrease in anxiety and increased reassurance women should have with the safer, earlier, and improved availability of results."
The sensitivity and specificity of the verifi™ test included in the model were based on Verinata's large prospective, blinded validation study recently published in Obstetrics & Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists. Test performance characteristics proved to be the major drivers of clinical benefit in the health economic model.
"The availability of this highly-sensitive, specific test that detects Down, Edwards and Patau syndromes is creating a major paradigm shift in the care of high-risk pregnancies," said Anthony Odibo, M.D., maternal fetal medicine specialist at Barnes-Jewish Hospital and medical director for the Fetal Care Center and associate professor of obstetrics and gynecology at Washington University School of Medicine in St. Louis. "Based on these robust analyses, particularly the finding that this test significantly reduces the number of avoidable invasive procedures and resulting miscarriages, we believe that with increasing experience, non-invasive prenatal tests may replace current screening protocols, becoming the primary screen for aneuploidy."
The clinical and economic utility of the verifi™ prenatal test, based on findings from the model and clinical practice, will be presented by Dr. Garfield and Dr. Odibo on April 27, 2012, at the Spring Forum of the National Association of Managed Care Physicians in Orlando, FL.
Additional presentations and publications regarding the clinical, economic and technological benefits of the verifi™ prenatal test will be presented at upcoming meetings.
About the verifi™ prenatal test
The verifi™ prenatal test is a blood test that analyzes genetic material (or DNA) naturally found in a pregnant woman's blood to detect Down syndrome (trisomy 21 or T21), Edwards syndrome (trisomy 18 or T18) and Patau syndrome (trisomy 13 or T13) in the fetus. When directed by a physician, the verifi™ prenatal test can be offered to a pregnant women of at least 10 weeks gestation at high risk of carrying a fetus with a genetic abnormality. A physician may classify a woman as "high-risk" if she is over 35 years of age, has a prior personal or family history of chromosome abnormalities, or has had a positive initial screening test indicating she is at increased risk for carrying a fetus with a genetic abnormality.
Verinata Health, Inc.
Verinata is driven by a sole, extraordinary purpose – maternal and fetal health. Our initial focus is to develop and offer non-invasive tests for early identification of fetal chromosomal abnormalities using our proprietary technologies. We aim to reduce the anxiety associated with today's multi-step process, the unacceptable false-positive rates, the non-specific and sometimes confusing results of current prenatal screening methods, as well as the risk of current invasive procedures. In support of national guidelines recommending first trimester aneuploidy risk assessment, we believe women who desire such an assessment should be offered a single blood draw test with a definitive result. The verifi™ prenatal test is available throughout the United States, with the exception of New York, through a physician. For more information about Verinata, please go to www.verinata.com.
SOURCE Verinata Health, Inc.