MRC Holland Gets CE-IVDR Certification for Imprinting Disorders Test

Original from: 360dx

MRC Holland said Thursday that its blood-based assay for Temple, Kagami-Ogata, and Russell-Silver syndromes has received certification under Europe's In Vitro Diagnostic Regulation (IVDR).

The three conditions are caused by a disturbance of the parent-specific monoallelic expression of genes in the 7q32, 7p12, and 14q32 imprinted regions, according to MRC Holland. The test — called SALSA MLPA Probemix ME032 UPD7-UPD14 — detects copy number variations and methylation statuses of the regions by analyzing genomic DNA isolated from peripheral whole blood.

Last month, Amsterdam-based MRC Holland received IVDR certification for a phenylketonuria detection test. The company said that it expects its other SALSA MLPA Probemix tests for the detection of aberrant methylation-related conditions to obtain CE-IVDR certification in the coming year, ensuring the availability of IVDR-compliant products across its menu ahead of the regulation's mandatory implementation deadline.

Source: MRC Holland Gets CE-IVDR Certification for Imprinting Disorders Test