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Sequenom Gets NY State Lab Permit

NEW YORK (GenomeWeb News) – Sequenom today said that its San Diego lab, the Sequenom Center for Molecular Medicine, has received a clinical laboratory permit from New York Department of Health's Wadsworth Center Clinical Laboratory Evaluation Program.

The permit, Sequenom said, allows it to provide its MaterniT21 Plus test to healthcare professionals in the state of New York, effective Aug. 1. The test analyzes the relative amount of 21, 18, 13, as well as X and Y chromosomal material in cell-free DNA, and it is intended for use in pregnant women at increased risk for fetal aneuploidy.

Verinata Health, a competitor to Sequenom that is owned by Illumina, announced Friday that it had received its clinical lab permit from New York, enabling the firm to offer its Verifi non-invasive prenatal diagnostic test in the state. The test, also for trisomy 21, 18, and 13 and sex chromosome abnormalities, can now be offered by Verinata in all 50 states.

Sequenom had announced in January 2012 that its earlier version of the test, the MaterniT21, was available through its Sequenom Center for Molecular Medicine in all 50 states in the US, including New York.

In addition to announcing the NY state lab permit, Sequenom also said today that its CLIA lab in North Carolina has received accreditation by the College of American Pathologists.