MRC Holland received CE-IVDR certification for the SALSA MLPA Probemix P008 PMS2 assay, a blood-based test for cancer-predisposition conditions linked to PMS2. The assay detects deletions and duplications across defined exons of PMS2 and PMS2CL using multiplex ligation-dependent probe amplification. The certification expands MRC Holland’s portfolio of CE-IVDR-approved blood tests, which the company says now includes assays for Peutz-Jeghers syndrome, spinal muscular atrophy, and breast and ovarian cancer syndrome. For clinicians, the update supports more standardized genomic risk assessment under Europe’s In Vitro Diagnostic Regulation framework.
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