NEW YORK – Canadian molecular diagnostics company Syantra said on Tuesday that its Syantra DX Breast Cancer Test has gained a CE-IVD mark.
The blood-based test evaluates the expression patterns of 12 biomarkers using qPCR and machine-learning tools. The Calgary-based company said that the Syantra DX Breast Cancer Test can detect the disease early, particularly in women at higher risk of developing cancer.
A company representative clarified via email that the test was certified last year under the EU's In Vitro Diagnostic Directive (IVDD), before the new IVD Regulation (IVDR) began to apply.
Syantra will still be able to market its test to European clinicians for several years before it will require new certification under the IVDR, due to extended grace periods for tests holding CE-IVD marks obtained under the IVDD.
Syantra CSO Kristina Rinker said in a statement that the certification brings the company "one step closer to helping women across the globe detect breast cancer at earlier stages when it is most treatable."