IVDR certification for breast and ovarian cancer assays

Image source: MRC Holland

These assays are the company’s first oncology-related diagnostic tests to be added to their IVDR certificate. This achievement signifies that MRC Holland is well on track to ensure that the vast majority of MRC Holland’s IVDD-certified assays are IVDR compliant before the mandatory implementation deadline in December 2028. 

HBOC syndrome is an inherited genetic disorder that results in an increased risk of breast and ovarian cancer. A major cause of HBOC syndrome are defects in the BRCA1 and/or BRCA2 genes, including deletions and duplications of entire exons. In this regard, SALSA MLPA Probemix P002 BRCA1, SALSA MLPA Probemix P090 BRCA2 and SALSA MLPA Probemix P045 BRCA2/CHEK2 can be used for initial detection of copy number variations in BRCA1 and BRCA2. An added advantage of using these products is the availability of the follow-up assays SALSA MLPA Probemix P087 BRCA1 Confirmation and SALSA MLPA Probemix P077 BRCA2 Confirmation, which allow laboratories to rely on a single well-trusted technique to confirm detected genetic aberrations, MRC Holland points out. 

With the addition of these five assays to the IVDR certificate, MRC Holland offers the possibility to diagnose HBOC syndrome and to test at-risk family members based on the highest European quality standards. Furthermore, this milestone ensures that diagnostic laboratories have access to reliable, straightforward and high-quality MLPA assays for years to come, the company reports. 

Source: MRC Holland

19.02.2025

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