MRC Holland Gets CE-IVDR Certification for Spinal Muscular Atrophy Tests

Original from: 360dx

Dutch diagnostics firm MRC Holland said Friday that two of its blood-based assays for spinal muscular atrophy (SMA) have been certified under Europe's In Vitro Diagnostic Regulation (IVDR).

SMA is an autosomal recessive genetic disorder affecting motor neurons that results in progressive muscle weakness, according to the company. It is primarily caused by the absence of functional copies of the SMN1 gene.

The SALSA MLPA Probemix P060 SMA Carrier is designed to detect copy number variations in exons 7 and 8 of the SMN1 gene, while the SALSA MLPA Probemix P021 SMA detects copy number variations in SMN1, as well as in the related SMN2 gene. The assays are intended to aid in the diagnosis of SMA, as well as for carrier testing and molecular genetic testing of at-risk family members.

A number of MRC Holland's tests have received IVDR certification in recent months including a series of blood-based tests for hereditary breast and ovarian cancer syndrome and a test for Temple, Kagami-Ogata, and Russell-Silver syndromes.

Source: MRC Holland Gets CE-IVDR Certification for Spinal Muscular Atrophy Tests