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Multiplicom Gets CE-IVD Mark for Clarigo NIPT

NEW YORK (GenomeWeb)—Multiplicom announced today that it has received CE-IVD marking for its new non-invasive prenatal test Clarigo and has launched the test in countries that recognize the designation.

Clarigo makes use of Multiplicom’s proprietary Multiplex PCR technology and performs targeted, massively parallel sequencing (MPS) for analyzing cfDNA. The Belgian firm said that fetal DNA can be analyzed in the mother's blood as early as eight weeks into the pregnancy, and Clarigo is designed to detect the presence or absence of major chromosomal abnormalities in the fetus, such as trisomy 21 (Down's syndrome), 18 (Edwards' syndrome), and 13 (Patau syndrome).

The increased sensitivity and reliability of the test provides far fewer false-positive results compared to present combined testing, sparing a large number of pregnant women from invasive procedures, Multiplicom said in a statement. However, if the test finds more than two copies of chromosome 21, 18, or 13 in the fetus, the pregnant woman will be referred to classic invasive procedures to confirm the result.