NEW YORK (GenomeWeb News) – German firms GATC Biotech and LifeCodexx announced today that they have begun a clinical validation study of a non-invasive, prenatal diagnostic test for Trisomy 21 based on next-generation sequencing technology.
The firms expect to collect 150 samples soon for study that they believe will require at least 500 samples. They have already validated their method on the Illumina HiSeq 2000 platform using 38 samples and will use that platform for the commercial version of the test.
“Our method allows pooling of at least seven samples for parallel analysis on the HiSeq 2000,” LifeCodexx CEO Michael Lutz said in a statement, “[I]in this manner we can sink the costs per analyzed sample by more than 50 percent. We are right on our schedule with the validation study and are confident that we will be able to launch the prenatal diagnostic test onto the market as planned at the end of 2011.”
Lutz previously told GenomeWeb Daily News sister publication Clinical Sequencing News that LifeCodexx's primary market would be Europe, and it has no plans to launch its test in the US.
The partners expect to report the results of their current studies on the test at conferences this month in Malta and next month in Portugal.
The firms join Sequenom and Verinata in the race to develop and market a sequencing-based test for Down syndrome. Sequenom Chairman and CEO Harry Hixson recently told investors at the Jefferies Global Healthcare Conference that the firm remains on track to launch its SensiGene T21 test as a laboratory-developed test at the end of this year or in the first quarter of 2012.
Verinata, formerly Artemis Health, also plans to launch its T21 test late this year or in the first quarter of 2012 as an LDT. The test will run on the Illumina HiSeq 2000 platform.
In addition, Fluidigm holds a license to intellectual property covering a sequencing-based approach to detect Down syndrome. That technology was co-exclusively licensed to Verinata.
Last month GATC and LifeCodexx said that they will co-develop a genetic diagnostic test for the early detection of preeclampsia. Peter Pohl, CEO of GATC, said at the time that the company would investigate Pacific Biosciences' RS next-gen sequencing technology for use in the test protocol.