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LifeCodexx Begins Clinical Validation Study of Sequencing-Based T21 Test

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With a pilot study complete, scientists from GATC Biotech subsidiary LifeCodexx have started the clinical validation study of a sequencing-based trisomy 21 test, which it plans to launch by the end of the year.

The company will conduct the clinical validation study on 500 samples in conjunction with several European prenatal centers on the Illumina HiSeq 2000. In a statement, CEO Michael Lutz said the researchers would pool up to seven samples, which would help cut costs by 50 percent.

In the pilot study, completed this past April, the researchers tested their assay on 45 patients (CSN 4/19/2011). While the company has not published the results of the pilot test or disclosed details on its methodology, according to Lutz, the test achieved 100 percent sensitivity and specificity, and is very similar to the method that Sequenom is basing its trisomy 21 test on.

The LifeCodexx test will be launched in Europe as a lab-developed test, and Lutz has previously said that it has no plans to market its test in the US. Sequenom and Verinata Health are also both planning to launch trisomy 21 tests as LDTs by the end of this year or early next year (CSN 5/4/2011), and Sequenom is planning to file for pre-market approval from the US Food and Drug Administration by the end of 2012 (CSN 6/15/2011).

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