NEW YORK (GenomeWeb News) – Aria Diagnostics said today that it has begun a blinded, multicenter clinical trial that will compare its non-invasive prenatal trisomy 21 screening test with standard screening methods.
The company's test, which is still in development, is based on a sequencing-based method that analyzes cell-free DNA in maternal blood to detect fetal chromosomal abnormalities.
The trial, which will enroll 25,000 pregnant women, will compare Aria's test to standard first-trimester screening tests, which include serum screening and nuchal translucency ultrasound alone and in combination.
The study will seek to show that Aria's test offers a more cost-effective and efficient option than currently available methods.
The company, which earlier this week announced that it had raised more than $50 million to commercialize its test, said that the Non-Invasive Chromosomal Examination of Trisomy, or NEXT, study "is the largest clinical study ever to directly compare first-trimester prenatal testing options."
The 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 Norton, MD, director of perinatal research at Lucile Packard Children's Hospital at Stanford University and co-principal investigator of the study.
Participants in the trial will include women 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. Those receiving standard first-trimester screening will also receive a nuchal translucency measurement performed via ultrasound.
Aria said that the trial will differ from other trials involving cell-free DNA analysis because "the complete pregnancy will be followed, including newborn medical records following birth."
Aria's primary competitor in the noninvasive prenatal testing market, Sequenom, launched its MaterniT21 test last year. A clinical trial for the test was published by Dennis Lo and colleagues at the Chinese University of Hong Kong in the British Medical Journal last January. That study evaluated around 700 pregnant women.