MRC Holland Gets CE-IVDR Certification for Breast, Ovarian Cancer Syndrome Tests

Original from: 360dx

Dutch diagnostics firm MRC Holland said this week that five of its blood-based tests for hereditary breast and ovarian cancer (HBOC) syndrome have received certification under Europe's In Vitro Diagnostic Regulation (IVDR).

According to MRC Holland, HBOC syndrome is an inherited genetic disorder — often caused by defects in the BRCA1 and BRCA2 genes — that results in an increased risk of breast and ovarian cancer.

The company's newly IVDR-certified SALSA MLPA Probemix P002 BRCA1, SALSA MLPA Probemix P090 BRCA2, and SALSA MLPA Probemix P045 BRCA2/CHEK2 allow for the detection of copy number variations in BRCA1 and BRCA2 by analyzing genomic DNA isolated from peripheral whole blood.

Two follow-up assays — SALSA MLPA Probemix P087 BRCA1 Confirmation and SALSA MLPA Probemix P077 BRCA2 Confirmation — have also been IVDR certified, the company said.

SALSA MLPA (multiplex ligation-dependent probe amplification) is a multiplex PCR technique that uses a single primer pair to amplify up to 60 probes, each with a unique genomic target and length.

Earlier this month, MRC Holland received IVDR certification for its blood-based assay for Temple, Kagami-Ogata, and Russell-Silver syndromes. And last month, IVDR certification was granted for its phenylketonuria detection test.

Source: MRC Holland Gets CE-IVDR Certification for Breast, Ovarian Cancer Syndrome Tests