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Medical Devices / Submissions and Approvals

PerkinElmer Earns CE-IVD Mark for Prenatal Testing Device

Nov. 27, 2018
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PerkinElmer earned a CE-IVD mark for its Vanadis non-invasive prenatal testing (NIPT) platform.

The test allows patients to screen for trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome) and trisomy 13 (Patau syndrome).

The device measures maternal plasma via targeted fluorescent labeling and the counting of specific cfDNA fragments, removing data-intensive steps required by gene sequencing or microarray testing.

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