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ARTICLE | Clinical News

Verifi prenatal test diagnostic data

March 3, 2014 8:00 AM UTC

The prospective, blinded, U.S. Comparison of Aneuploidy Risk Evaluations (CARE) study in maternal blood samples from 1,914 women with singleton pregnancies showed that the verifi prenatal test met the primary endpoint of reducing false positive rates in detecting fetal trisomy 18 (0.2% vs. 0.6%, p=0.03) and trisomy 21 (0.3% vs. 3.6%, p<0.001) vs. standard screening. Standard screening comprises serum biochemical assays with or without measurement of the thickness of the fetal nuchal translucency on ultrasonography. Both the verifi prenatal test and standard screening detected all cases of trisomies 18 and 21. The verifi prenatal test had a higher positive predictive value (PPV) for predicting trisomy 18 (40% vs. 8.3%) and trisomy 21 (45.5% vs. 4.2%) vs. standard screening. The verifi prenatal test was not significant vs. standard screening on the secondary endpoint of reducing false positive rate in detecting fetal trisomy 13 in 899 women in whom standard screening results included a risk assessment for trisomy 13. Specifically, there was 1 false positive using the verifi prenatal test vs. 6 false positives using standard screening (p=0.059). Data were published in New England Journal of Medicine. ...