Aria Diagnostics, a molecular diagnostics company, announced that it is initiating a blinded, multicenter clinical trial that compares its non-invasive prenatal test with the standard first-trimester screening test (serum screening and nuchal translucency ultrasound alone and in combination) to detect Trisomy 21, which is associated with Down syndrome. Aria's test, which is currently in development, uses a directed, non-invasive approach to cell-free DNA (cfDNA) analysis in maternal blood for evaluation of common fetal trisomies linked to genetic disorders.
"This new clinical trial stands out from previous research conducted on prenatal testing to date - not only due to the sheer sample size, but also because it will provide insights into how prenatal testing works in day-to-day practice," said Mary E. Norton, MD, director of perinatal research, Lucile Packard Children's Hospital at Stanford and co-principal investigator of the study. "In addition, the trial will highlight how Aria's non-invasive prenatal test may offer a more cost-effective and efficient option that is feasible for use in a wide population."
In addition to comparing the performance characteristics of Aria's test with standard first-trimester screening for T21 detection, the NEXT (Non-Invasive Chromosomal Examination of Trisomy) study will help define for healthcare providers the optimal clinical testing practice for first trimester testing. The trial of the Aria test is the largest clinical study ever to directly compare first-trimester prenatal testing options. Researchers are enrolling 25,000 women, ages 18 years or older, who are pregnant with one fetus and planning a hospital delivery. Blood samples will be collected between 10 and 14 weeks, and those receiving the standard first-trimester screening will also receive a nuchal translucency measurement performed via ultrasound. Unlike previous clinical trials involving cell-free DNA analysis, the complete pregnancy will be followed, including newborn medical records following birth.
During the participants' enrollment visit, investigators will document demographics and baseline characteristics, determine gestational age, perform serum screening tests, measure nuchal translucency and collect blood samples for the Aria test. Following delivery, investigators will document the newborn's phenotype (observable characteristics) with any genetic testing performed in the first 28 days of life using a review of the newborn's medical record. All methods and combinations of methods will be compared using pre-defined statistical analysis.
"This clinical trial marks an important milestone as we look to expand on our earlier findings by demonstrating the success of the Aria test on a much larger scale," said Ken Song, Chief Executive Officer of Aria Diagnostics. "We continue to work to make molecular diagnostics more affordable and accessible to a broad population. We look forward to sharing more details about the test and our marketing plans during the JP Morgan Healthcare Conference."