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Sagentia, Premaitha Partner on IVD for Prenatal Screening

NEW YORK (GenomeWeb) – Sagentia and Premaitha Health today said they are partnering to develop a non-invasive in vitro diagnostic test to determine the risk of conditions such as Down syndrome.

The Iona test uses cell-free DNA isolated from a sample of maternal blood to estimate the risk of a fetus having Down syndrome and other serious genetic conditions. The test, the partners said, could lead to a reduction in invasive procedures such as amniocentesis used for such analysis, and is being directed at clinical laboratories that already offer other prenatal screening tests.

As part of the deal, Sagentia will develop a custom, dedicated bioinformatics analysis package that will be part of Iona's clinical workflow and will use multicore analysis algorithms to automatically process and interpret sequenced DNA fragments and clinical data and generate test reports.

Sagentia and Premaitha said that they anticipate completing clinical performance and commercialization testing of Iona by the end of 2014, and launching the assay with CE marking in the first quarter of 2015.

Financial and other terms of the deal were not disclosed.

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