Tag Archives: clinical study

Race Against Time of Validation Study of Trisomy 21 Diagnostic Test II

Sequenom announced this week that they have entered into a supply agreement with Illumina for sequencing equipment and consumables. They will purchase the Illumina products for use in developing its non-invasive trisomy 21 test.

Sequenom plan to launch its SensiGene T21 test as a laboratory-developed test at the end of 2011 or in Q1 2012. The company also had previously disclosed that it had completed a validation study of its test on the Illumina HiSeq platform in 2,000 high-risk pregnancies, which will serve as the basis for the LDT.

It keeps exciting what GATC and Verinata are doing (resp. launching) in the meanwhile…

Race Against Time of Validation Study of Trisomy 21 Diagnostic Test I

Scientists at GATC Biotech AG and LifeCodexx AG have just begun the clinical validation study of a non-invasive, prenatal diagnostic test based on next generation sequencing with IlluminaHiSeq 2000 technology. The test detects fetal trisomy 21 and is based on the sequencing cell-free fetal DNA from maternal blood.

At least 500 samples are required for the study and the launch of the prenatal diagnostic test onto the market is planned at the end of 2011. It keeps exciting what Sequenom and Verinata are doing in the meanwhile…