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

纽约——Fulgent Genetics于周四宣布，其生殖细胞系下一代测序服务已获得CE-IVDR认证。

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.

CE标志涵盖了该公司的FulgentExome，这是一项包含超过4600个基因的端到端种系测试，已验证用于诊断。总部位于加利福尼亚州埃尔蒙特的实验室服务和治疗公司表示，该标志还涵盖相关的Fulgent Pipeline Manager软件。

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.

Fulgent公司表示，外显子组分析服务旨在通过检查编码区和剪接连接点，识别可能与临床和家族病史相关的遗传变异，从而协助诊断遗传疾病，且仅报告具有合理临床相关性的变异。

'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.

“凭借出色的周转时间和质量，我们认为我们现在可以在欧洲提供一项引人注目的服务，”Fulgent的首席商务官布兰登·珀尔特伊斯表示，并补充说CE标志是公司全球业务增长的一步。

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..

CE标志现在使Fulgent能够将FulgentExome提供给欧洲的诊所和医院系统，Perthuis表示，这将“帮助家庭获取复杂临床表型的答案”。他补充道，FulgentExome现在还可以作为临床试验的纳入测试，并有助于确保公共卫生项目符合欧洲体外诊断法规下的报销途径资格。

In February, Fulgent Genetics

今年2月，富乐基因

partnered with Roche subsidiary Foundation Medicine

与罗氏子公司Foundation Medicine合作

to launch two new NGS-based germline tests in the US.

在美国推出两项新的基于NGS的种系测试。