Swiss data company Sophia Genetics has secured a CE mark for its genomic analysis platform under the EU’s revised In Vitro Diagnostics Regulation (IVDR).
The IVDR CE mark certifies that the company’s Sophia DDM platform's genetic analysis meets the European IVDR 2017/746 requirements, which govern the sale of IVD devices within the European Economic Area (EEA).
"This was a top priority for our team to ensure a seamless transition for our current CE-IVD customers so they can continue to use the Sophia DDM platform to support diagnosis and treatment decisions for patients facing cancer," commented Sophia Genetics chief legal and compliance officer, Daan Van Well.
IVDR is a replacement to the EU’s former In Vitro Diagnostic Directive (IVDD) that is aimed at improving clinical safety and enhancing transparency for IVD manufacturers. It entered into force on 26 May 2017 and became applicable on 26 May 2022.
The IVDR stratifies IVDs at different risk levels. Provisions for the applicability of the rules were poised to apply from 26 May 2025 for high risk IVDs or 26 May 2027 for lower risk IVDs.
However, in January 2024, the European Commission (EC) proposed a revision to the IVDR, noting that a “considerable number” of IVDs on the market did not comply with the new rules and had not been replaced with new devices.
The EC noted that this situation was particularly critical for high-risk IVDs used, to test for infections in blood and organ donations.
The EC’s proposed revisions to the directive’s implementation timeline would mean high individual and public health risk devices (class D) like HIV or hepatitis tests would have a transition period until December 2027; high individual and/or moderate public health risk devices like cancer tests (class C) a transition period until December 2028; and lower risk devices, including pregnancy tests, which fall under class B, and class A sterile devices such as blood collection tubes, a transition period until December 2029.
According to GlobalData analysis, there are 127 NGS tests in active stages of development.
In March 2024, Sophia Genetics reported a 27% year over year revenue rise in its fourth quarter ended 31 December.
Other companies that recently secured a CE mark under the IVDR include Invivoscribe for its LeukoStrat assay and Bio-techne’s Asuragen’s QuantideX diagnostic test.
