The World's Largest Study to date
iGene® has been clinical validated on the largest study to date, with over 146,000 samples¹. The sample size of over 146,000 is important to make credible inferences about its efficacy in average risk pregnancies. iGene® delivers high positive predictive values compared to other NIPT tests. In practice, a test designed using a small sample size would result in large confidence intervals.
Compared to other tests, iGene® has tight confidence levels, at 95% for trisomies 21, 18 and 135,6, respectively highlighting the superior accuracy of this test. The larger the Confidence Intervals (CI) gap, the less accurate the test, and less reliable is the true sensitivity and specificity estimates.
Source 1. Zhang H, et al.(2015) Ultrasound Obstet. & Gynecol. 10.1002/uog.14792. 2. McCullough, Ron M. et al. (2014) PLoS ONE. 3. Norton et al 2015 N Engl J Med. 4. Dar, P et al. 2014. Am J Obstet Gynecol 5. Dan S, et al. Prenatal Diagnosis 2012, 32(13), 1225-32 6. Jiang FM, et al. BMC Medical Genomics, 2012, 5:57