San Jose, Calif., May 23, 2012 – Ariosa Diagnostics, a molecular diagnostics company, announced today the publication of a study that provides more information on the factors which may influence the amount of fetal DNA found in maternal blood. The study was led by Professor Kypros Nicolaides, MD, of Harris Birthright Research Centre for Fetal Medicine at King’s College Hospital in the United Kingdom.
The study demonstrated that fetal DNA amounts did not differ significantly between pregnant women who have Trisomy 21 fetuses (associated with Down syndrome) and those who have euploid fetuses (no trisomy). Maternal weight and serum screening markers were found to correlate with fetal DNA amounts suggesting that placental size relative to the mother is the major factor influencing fetal DNA concentration in maternal blood. The study, which will be published in a future print edition of Fetal Diagnosis & Therapy, is available now online at http://content.karger.com/produktedb/produkte.asp?DOI=10.1159/000337373.
“The ability to detect Trisomy 21 with cell-free DNA is dependent upon assay precision and fetal fraction in the sample rather than upon the prevalence of disease in the study population,” stated Professor Nicolaides. “While further studies are warranted, our results suggest that cell free DNA testing may be applicable in both high and low risk pregnancies.”
“We are committed to advancing science and research in the field of non-invasive prenatal testing,” said Ken Song, chief executive officer at Ariosa Diagnostics. “It is important that clinical data and scientific principles take center stage as non-invasive tests, such as the HarmonyTM Prenatal Test, are used by healthcare providers to manage pregnant women. This additional research into the presence of fetal DNA in maternal blood will help us to better identify which patients may be appropriate for prenatal testing.”
Ariosa Diagnostics developed the Harmony Prenatal Test, which is currently available in selected US locations and will be broadly available in June. The Harmony Prenatal Test is performed using a simple maternal blood draw and detects fetal trisomy via analysis of cell-free DNA in maternal blood.