NEW YORK – Dutch molecular diagnostics reagent firm MRC Holland said Friday that its phenylketonuria detection test has received certification under Europe's In Vitro Diagnostic Regulation (IVDR).
The assay, SALSA MLPA Probemix P055 PAH, uses multiplex ligation-dependent probe amplification (MLPA) for postnatal and carrier detection of phenylketonuria or PAH deficiency caused by copy number variations of the PAH gene. PAH deficiency creates a buildup of phenylalanine in the blood and brain, which results in intellectual disability, epilepsy, and behavioral problems.
According to Amsterdam-based MRC Holland, the company expects to see the majority of its other assays 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.
Amongst other applications of the firm's SALSA MLPA technology are tests for hereditary disorders and hereditary cancer.