MRC Holland has announced that its Melt Assay SALSA MC002 SMA Newborn Screen was recently CE-marked for in vitro diagnostic (IVD) use under the new In-Vitro Diagnostic Regulation EU 2017/746 (IVDR). This makes it the company’s first product to be added to the IVDR certificate.
The company says this achievement marks a significant milestone, as its mission is to provide high- quality, affordable genetic tools is fully aligned with the enhanced quality standards ensured by the IVDR.
MC002 SMA Newborn Screen is a solution for first-tier screening for spinal muscular atrophy (SMA). SMA is a severe genetic disorder affecting motor neurons and leading to progressive muscle weakness.
MRC Holland says the approval of the product for diagnostic use under the IVDR solidifies its place as a trustworthy and valuable component of current neonatal screening programs. The company says that it also ensures that laboratories in the EU can be confident that it meets the most stringent effectiveness and safety criteria.
Read more: Regulation
The assay uses melt curve analysis to determine the presence or absence of exon 7 in SMN1 and SMN2 genes using a simple dried blood spot (DBS) punch. This approach enables rapid turn-around times, providing a crucial first step in the timely diagnosis of patients.
The IVDR came into effect in May 2022, replacing the previous regulations, called In Vitro Diagnostic Directive (IVDD). It is intended to be a more comprehensive regulation that introduces a more stringent framework for IVD devices and a new risk-based classification scheme.
Under the IVDR, 80% of all In Vitro Diagnostic devices are subject to an independent review by a notified body. Manufacturers must provide more in-depth data to substantiate their safety and performance claims.
MRC Holland is a biotechnology company specialising in the production of assays for copy number determination and methylation status detection in hereditary disorders and tumours.
