- Panel also includes atypical pathogens such as Pneumocystis jirovecii
LRT BAL Panel expected to substantially increase total addressable market for Unyvero System in theU.S.
The LRT BAL panel will be commercially available to Curetis’
The Unyvero LRT BAL application is the first and only FDA-cleared molecular diagnostic pneumonia panel that includes Pneumocystis jirovecii. As culture-based diagnosis of Pneumocystis jirovecii Pneumonia (PJP) is not possible, identification of this pathogen is often based on morphological detection techniques, which are labor-intensive and time-consuming and lack sensitivity. Rapid diagnosis of PJP, which causes severe and life-threatening symptoms, is crucial in patients with a weak or suppressed immune system. Initiating the appropriate therapy even one day earlier can significantly reduce mortality in this patient group.
“Pneumocystis jirovecii is a leading cause of pneumonia in immunocompromised individuals. Several features unique to Pneumocystis make its diagnosis difficult. No combination of symptoms, signs, and chest radiographic findings is diagnostic of Pneumocystis Pneumonia, the organism cannot be cultured, and its diagnosis currently relies on microscopic visualization of the characteristic cysts and/or trophic forms on stained respiratory specimens,“ said
Beyond Pneumocystis jirovecii, the LRT BAL panel detects a broad spectrum of clinically relevant causative agents, including atypical pathogens, as well as antibiotic resistance markers. Thereby, it provides clinicians with a valuable diagnostic tool that informs early and supports appropriate antibiotic treatment decisions in this indication.
Infections with atypical pathogens are often associated with community-acquired pneumonia (CAP), but are not considered in the context of hospital-acquired or ventilator-associated pneumonia. Therefore, hospitalized patients usually are not tested for these organisms unless there is a suspicion of infection. Further, empiric treatment of these patients does not normally cover atypical pathogens. Unyvero LRT BAL expands the diagnostic capability of clinicians to routinely identify atypical infections that might otherwise escape detection and hence can prevent prolonged inappropriate treatment of patients.
Indiscriminate overuse and misuse of antibiotics are key drivers of dramatically spreading antibiotic resistance, a substantial global health threat. A report recently issued by the
By providing a fast and reliable solution for the rapid detection of pathogens and antibiotic resistance markers, Unyvero LRT BAL is an essential, indispensable tool for targeted antimicrobial therapy improving patient outcomes while facilitating stringent antibiotic stewardship.
“Unyvero LRT had already been cleared by the
“We are excited about this launch on the heels of the recent FDA clearance decision. We expect that the launch of our LRT panel for BAL samples will significantly increase the total addressable market for our Unyvero System in the U.S.,” said
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Reference
1)
The full 2019 AR Threats Report, including methods and appendices, is available online at www.cdc.gov/DrugResistance/Biggest-Threats.html.
About
Curetis N.V.’s (Euronext: CURE) goal is to become a leading provider of innovative solutions for molecular microbiology diagnostics designed to address the global challenge of detecting severe infectious diseases and identifying antibiotic resistances in hospitalized patients.
Curetis’ Unyvero System is a versatile, fast and highly automated molecular diagnostic platform for easy-to-use, cartridge-based solutions for the comprehensive and rapid detection of pathogens and antimicrobial resistance markers in a range of severe infectious disease indications. Results are available within hours, a process that can take days or even weeks if performed with standard diagnostic procedures, thereby facilitating improved patient outcomes, stringent antibiotic stewardship and health-economic benefits. Unyvero in vitro diagnostic (IVD) products are marketed in
Curetis’ wholly-owned subsidiary
For further information, please visit www.curetis.com andwww.ares-genetics.com.
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Contact details
Curetis’ Contact Details
Max-Eyth-Str. 42
71088 Holzgerlingen,
Tel. +49 7031 49195-10
pr@curetis.com or ir@curetis.com
www.curetis.com - www.unyvero.com
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akampion
Dr.
Managing Partners
info@akampion.com
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68
Attachment
- 20200114_Curetis_PR_BAL_Launch_final_approved_aka_final_clean
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