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MRC Holland Gets CE-IVD Mark for Spinal Muscular Atrophy Assay

NEW YORK (GenomeWeb) — Dutch biotech firm MRC Holland said recently that it has received CE-IVD marking for its SALSA MC002 assay for spinal muscular atrophy (SMA) screening in newborns. It added it has launched the test.

SMA is a neuromuscular disease caused by mutations in the SMN1 gene. According to MRC Holland, the melt curve analysis-based assay is designed to detect the presence or absence of SMN1 exon 7 in newborns. It does not require DNA purification and can provide results from dried blood spot card punches in around four hours.

MRC Holland noted that the market for SMA screening has increased with the 2016 approval of Biogen Idec's treatment Spinraza (nusinersen), which is administered before symptoms appear.