NEW YORK – Devyser announced Thursday that it received In Vitro Diagnostics Regulation (IVDR) certification in the EU for its Advyser Solid Organs kidney transplant health monitoring software.

纽约–Devyser周四宣布，其Advyser实体器官肾移植健康监测软件已在欧盟获得体外诊断法规（IVDR）认证。

The post-transplant software analyzes next-generation sequencing data from the Swedish firm's One Lambda Devyser Accept cfDNA assay for detecting donor-derived cell-free DNA (dd-cfDNA) in kidney transplant patients. That assay received IVDR certification last year.

移植后软件分析了瑞典公司One Lambda Devyser Accept cfDNA分析的下一代测序数据，用于检测肾移植患者的供体来源的无细胞DNA（dd-cfDNA）。该检测方法去年获得了IVDR认证。

'Achieving IVDR certification for our software demonstrates Devyser's commitment to pioneering genetic testing,' Devyser CEO Fredrik Alpsten said in a statement. 'This approval is another confirmation of our strong regulatory expertise and testament to the high quality, safety, and compliance of Devyser products.

Devyser首席执行官弗雷德里克·阿尔普斯滕（FredrikAlpsten）在一份声明中说，为我们的软件获得IVDR认证证明了Devyser对开创基因检测的承诺这一批准再次证实了我们强大的监管专业知识，并证明了Devyser产品的高质量、安全性和合规性。

We are confident this approval will further enhance the growth potential of our transplantation products.' .

我们相信这一批准将进一步提高我们移植产品的增长潜力。”。

Last month, the company published a study demonstrating the ability of its One Lambda assay to discriminate dd-cfDNA from multiple kidney donors in a single recipient, as part of its push to eventually obtain US regularoty approval.

上个月，该公司发表了一项研究，证明了它的一种λ测定法能够在一个受体中区分来自多个肾脏供体的dd-cfDNA，作为其最终获得美国监管部门批准的努力的一部分。