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LifeCodexx Validates T21 Test as it Completes Regulatory Approval to Launch as IVD

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This story was originally published on April 27.

GATC Biotech subsidiary LifeCodexx has completed the clinical validation of its sequencing-based prenatal trisomy 21 test, Praena Test, and is in the process of gaining regulatory approval to launch the test as an in vitro diagnostic test initially in Germany, Switzerland, Austria, and Liechtenstein.

LifeCodexx's trisomy 21 test is based on the same technology as Sequenom's MaterniT21 Plus test, from whom LifeCodexx licensed intellectual property to commercialize the test in Europe (CSN 8/17/2011).

Unlike MaterniT21 Plus, which analyzes trisomy 21, 13, and 18, the Praena Test evaluates only trisomy 21. Additionally, LifeCodexx validated the test to multiplex 12 samples at once, compared to Sequenom, which runs its test as a 4-plex. Like Sequenom, the test is run on Illumina's HiSeq 2000.

The study analyzed two methods of collecting blood — using conventional blood collection tubes and LifeCodexx's proprietary blood collection tubes — and found that the proprietary tubes, which require no prep work at the physicians' site, yielded higher sensitivity and specificity.

Using LifeCodexx's tubes, the test achieved 100 percent sensitivity and specificity, but when conventional blood collection methods were used, sensitivity was 81.8 percent and specificity was 98.7 percent.

For the study, five prenatal centers and university hospitals in Germany and Switzerland recruited 522 maternal samples from high-risk pregnancies, with 42 positive for trisomy 21. Gestational age ranged from 11 weeks to 32 weeks.

The test has the "long-term potential to considerably reduce the number of procedure-related pregnancy losses induced by invasive diagnostic methods," Markus Stumm, of the Berlin Center for Prenatal Diagnosis and Human Genetics, said in a statement.

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