REDWOOD CITY, Calif. — Illumina, Inc. (NASDAQ: ILMN) today announced Verinata Health, an Illumina company, published additional peer-reviewed data1 showing that Verinata’s non-invasive verifi® prenatal test2 correctly detects aneuploidies across all test samples, even for patients with very low fetal fractions (cell-free DNA fragments in maternal blood contributed from the fetus). The publication also documented that fetal fractions are different for pregnancies where the fetus has Down syndrome (trisomy 21), Edwards syndrome (trisomy 18), and other aneuploidies analyzed by the verifi® prenatal test.

“This publication validates that the Verinata Health approach to non-invasive prenatal testing based on deeper sequencing delivers highly accurate results regardless of the variation in fetal fraction across test samples,” said Jeffrey Bird, General Manager of Verinata Health. “Additionally, Verinata Health’s testing methodology results in a failure rate of less than one percent and the industry’s fastest turnaround time of three to six business days.”

The authors of the publication demonstrated that fetal fraction varies between different chromosomal aneuploidies. Fetuses with trisomy 21 have a higher fetal fraction when compared to fetuses without aneuploidy, whereas fetuses with trisomy 18, trisomy 13 (Patau syndrome) and monosomy X (Turner syndrome) have lower fetal fractions. The authors showed that by sequencing a larger number of fragments (~23 million DNA fragments per sample in the verifi® prenatal test), samples with lower fetal fractions are correctly classified.

“Verinata sequences more DNA fragments than any other provider, delivering reliable results with the verifi® prenatal test, regardless of the variation in fetal fraction,” said Richard Rava, Verinata’s Vice President of Research and Development. “In clinical practice we continue to see consistent, exceptionally high positive and negative predictive values3 for the test.”

This study analyzed the fetal fraction of 324 maternal blood samples from the MatErnal bLood IS Source to Accurately detect fetal aneuploidy (MELISSA) study.4