Fulgent Genetics' Germline NGS Testing Service Obtains CE-IVDR Mark

Original from: 360dx

Fulgent Genetics announced on Thursday that it has obtained the CE-IVDR mark for its germline next-generation sequencing service.

The CE marking covers the firm's FulgentExome, an end-to-end germline test with more than 4,600 genes validated for diagnostic use. It also covers the associated Fulgent Pipeline Manager software, the El Monte, California-based lab services and therapeutics firm said in statement.

The exome analysis service is intended to identify germline variants that can assist in the diagnosis of genetic conditions relevant to clinical and family history, Fulgent said, by examining coding regions and splice junctions reporting only the variants of plausible clinical relevance.

"With excellent turnaround time and quality, we believe we can now present a compelling service offering in Europe," said Brandon Perthuis, Fulgent's chief commercial officer, who added that the CE mark is a step toward growing the firm's global business.

The CE mark now enables Fulgent to make FulgentExome available to clinics and hospital systems in Europe, "helping families get answers to complex clinical phenotypes," Perthuis said. FulgentExome can also now be used as an inclusion test for clinical trials, he added, and to help ensure public health programs' eligibility for reimbursement pathways under Europe's In Vitro Diagnostic Regulation.

In February, Fulgent Genetics partnered with Roche subsidiary Foundation Medicine to launch two new NGS-based germline tests in the US.

Source: Fulgent Genetics' Germline NGS Testing Service Obtains CE-IVDR Mark