NEW YORK – Diasorin said on Tuesday that it has received CE marking under the EU's In Vitro Diagnostic Regulation for a molecular test to detect the fungal pathogen

纽约——Diasorin公司周二表示，其用于检测真菌病原体的分子测试已获得欧盟体外诊断法规下的CE认证。

Candida auris

耳念珠菌

, a common source of healthcare setting-associated infections.

，是医疗环境相关感染的常见来源。

The Saluggia, Italy-based firm said that the Simplexa

总部位于意大利萨卢贾的公司表示，Simplexa

C. auris

耳念珠菌

Direct kit is a real-time PCR assay that is used for the detection of DNA from six clades of the fungal pathogen in a composite axilla/groin swab sample from patients with suspected colonization, with results within two hours. The test is designed for use on the company's Liaison MDX instrument.

直接试剂盒是一种实时PCR检测方法，用于检测来自疑似定植患者的腋窝/腹股沟复合拭子样本中六种真菌病原体的DNA，检测结果在两小时内即可获得。该测试旨在公司Liaison MDX仪器上使用。

Diasorin said that the test can be used to help control the spread of infections in healthcare settings, including potentially deadly infections among vulnerable patients. Asymptomatic patients may be colonized with

索林公司表示，该测试可用于帮助控制医疗环境中感染的传播，包括在易感患者中可能致命的感染。无症状患者可能被定植。

C. auris

耳念珠菌

, which can spread between hospitalized patients and is a risk for invasive infections. The firm also noted that multidrug-resistant

，这种细菌可以在住院患者之间传播，并有引发侵袭性感染的风险。该公司还指出，多重耐药性

C. auris

耳念珠菌

is an emerging threat.

是一种新兴的威胁。

The firm also secured last year US Food and Drug Administration

该公司去年还获得了美国食品和药物管理局的批准

de novo

从头开始

marketing authorization

营销授权

for the Simplexa

适用于Simplexa

C. auris

耳念珠菌

Direct kit. Last week, Diasorin CEO Carlo Rosa said in a conference call related to the company's

直接套件。上周，Diasorin首席执行官卡洛·罗莎在与公司相关的电话会议上表示

FY 2024 earnings

2024财年收益

that the successful US launch of the assay had contributed to growth in the firm's molecular diagnostics revenues.

该测定方法在美国的成功推出促进了公司分子诊断收入的增长。