NEW YORK (GenomeWeb News) – GATC Biotech subsidiary LifeCodexx said today that it has completed the recruitment of more than 500 blood samples for a clinical study of its non-invasive prenatal diagnostic test for trisomy 21.
The Konstanz, Germany-based company said that the prospective and blinded study will evaluate its sequencing-based PraenaTest against "conventional invasive methods."
The test uses Illumina's HiSeq 2000 to sequence cell-free fetal DNA from maternal blood. The company said that it has increased multiplexing on the HiSeq from seven samples to twelve samples, "leading to increased cost efficiency."
LifeCodexx said that it has also simplified blood sampling and shipping so that physicians are "no longer required to prepare the blood plasma before shipping and can now send the sample at ambient temperature."
The company expects the results of the study to be available in the first quarter. It then plans to gain CE certification and roll out the test in German-speaking countries in the second quarter.
LifeCodexx holds a license to Sequenom's intellectual property that gives it the right to market its test in Europe. Sequenom markets its own sequencing-based trisomy test, MaterniT21, in the US.
A number of other players are entering the market for sequencing-based non-invasive prenatal testing. Yesterday, Aria Diagnostics announced that it had raised $52.7 million to commercialize such a test for fetal aneuploidies.