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Curetis Unyvero System, Lower Respiratory Tract Infection Cartridge Get FDA Clearance

NEW YORK (GenomeWeb) – German firm Curetis has been granted de novo clearance by the US Food and Drug Administration for a multiplex assay to detect lower respiratory tract infections, as well as for the firm's molecular diagnostic platform, Unyvero. The assay is the first multiplex lower respiratory tract infection test to be cleared by the FDA, the firm noted in a statement.

The Unyvero LRT cartridge detects pathogens accounting for more than 90 percent of cases of hospitalized patients with pneumonia, as well as genetic antibiotic resistance markers, directly from aspirate.

The test runs in under five hours, which is considerably faster than the microbiology culture that is the current standard of care. It performs 29 multiplexed PCR assays and can detect more than 30 Gram-positive and Gram-negative bacterial organisms known to cause lower respiratory tract infections as well as 10 genetic markers for antibiotic resistance, including resistance to carbapenem and third-generation cephalosporins.

The opportunity to characterize pneumonia by knowing the causative organism as well as relevant antibiotic resistance markers in four to five hours "is game changing and exciting," according to Donna Mildvan, an infectious diseases physician and professor of medicine at the Icahn School of Medicine at Mount Sinai in New York.

The clinical trial for the LRT cartridge included more than 2,200 patient samples at nine hospitals. Curetis noted that the approval also marks the first time the FDA has cleared an automated molecular diagnostic test that includes a Legionella pneumoniae target.

The firm said it expects to place 60 to 80 Unyvero Analyzers in the US within the first full year of commercial availability, which will begin in the second quarter and be coordinated by the executive leadership, regional sales directors and field-based territory sales managers, clinical application specialists, and service engineering and logistics support based in the firm's San Diego subsidiary, Curetis USA.

Curetis also intends to submit an application for a label claim extension to include the bronchial lavage sample types and several additional diagnostic targets. The company further noted that it is developing an invasive joint infections cartridge and said preparations for another prospective multi-center clinical trial for its second US Unyvero application are already underway.

Curetis will now make additional and accelerated investments in the US and continue to explore strategic and tactical options to finance its commercial roll out, the firm said.

Separately, Curetis announced that its commercial partner in the Association of Southeast Asian Nations region, Acumen Research Laboratories, has received clearance from the Singapore Health Sciences Authority to market the Unyvero blood culture cartridge to detect more than 103 diagnostic targets, including microorganisms and genetic markers of antibiotic resistance, that can lead to sepsis. The cartridge was CE marked in 2016 and is the second to be made available in Singapore following the approval of its pneumonia test earlier this year. Acumen is planning to next submit the Unyvero ITI Implant and Tissue Infection and Unyvero IAI Intra-Abdominal Infection application cartridges for HSA approval.