openPR Logo
Press release

Curetis Completes Enrollment for its EU Trial As Planned

10-10-2012 07:53 PM CET | Health & Medicine

Press release from: Curetis AG

/ PR Agency: akampion
- Prospective multi-center trial enrolls 800 patient samples in 7 months -

Holzgerlingen (Germany), October 9, 2012 -- Curetis AG today announced it has completed enrollment for the European clinical trial of its Unyvero™ Pneumonia Application on schedule. More than 800 patient samples were collected until September 30, 2012. Data analysis will be completed in early 2013. Subsequently, results will be published in a major, peer-reviewed journal.

The trial will compare the performance of the Unyvero™ P50 Pneumonia Cartridge with conventional microbiology culture, the current standard of care. Primary endpoint will be clinical sensitivity and specificity for the identification of 17 pathogens covered by the Unyvero™ P50 panel. Secondary endpoints include time to result and correlation of resistance marker detection with phenotypic antibiograms. Curetis will conduct systematic discrepant results resolution by PCR and sequencing to confirm the clinical truth in samples where Unyvero results differ from microbiology culture.

The study complements the previously completed CE performance evaluation study, in which the Unyvero P50 Cartridge identified a significant number of additional pathogens not detected by microbiology culture. These findings were confirmed by PCR analysis.

“We are happy to announce the successful completion of another major clinical project milestone,” said Oliver Schacht, CEO of Curetis. “Together with the more than 200 samples analyzed earlier this year, we now have data collected from over 1,000 samples tested, which will form a substantial body of clinical evidence around the Unyvero Solution and our Pneumonia Application.“

“While data analysis for the multicenter study will be ongoing for some time, we have already seen some rather exciting case studies of patients who might have benefited substantially from the rapid and comprehensive diagnostic solution offered by Curetis´ Unyvero Solution,” said Dr. Peter Keller of Friedrich-Schiller University in Jena. “With the testing completed on beta-prototypes of the Unyvero systems, we are now intrigued by the availability of fully CE-marked series-production instruments and look forward to a growing body of clinical data. We will continue working with the Curetis team to make the solution available to microbiologists and clinicians for routine use and to the benefit of our patients.”

###

About the Unyvero™ System
The CE-marked Unyvero™ System is a versatile hardware platform for the detection of a broad panel of bacteria and antibiotic resistances from a single sample in one run. It processes a disposable cartridge providing the necessary reagents to complete the analysis from sample to result.
The platform enables the DNA-based testing of all clinically relevant samples in a fully automated, unsupervised analysis process requiring only few, quick manual preparation steps. The analysis thus can be performed with minimal operator time and without the need of skilled staff or special infrastructure.
Thereby, clinically relevant information is available within about four hours to support an informed therapy decision as early as possible.
The first CE-marked Unyvero™ Cartridge, Unyvero™ P50, focuses on pneumonia testing and simultaneously analyses 39 DNA targets. The second Unyvero™ application for implant & tissue infections is already in product development. Cartridges for additional indications, such as blood stream infections and tuberculosis, are in preparation.

Media Inquiries
akampion
Dr. Ludger Wess / Ines-Regina Buth
Managing Partners
info(at)akampion.com
Tel. +49 40 88 16 59 64
Tel. +49 30 23 63 27 68

About Curetis AG
Founded in 2007, Curetis AG is a molecular diagnostics company which focuses on the development and commercialization of reliable, fast and cost-effective products for diagnosing severe infectious diseases. The diagnostic solutions of Curetis AG will enable rapid multiparameter pathogen and antibiotic resistance detection in only a few hours, a process that today can take up to days or even weeks with other techniques.
To date, Curetis has raised total funds of over € 36.6 million (~ USD 50 million). The company is based in Holzgerlingen near Stuttgart, Germany. Curetis has signed collaboration agreements with Heraeus Medical, Sanofi Pasteur and Cempra Inc. as well as several international distribution agreements.

Curetis AG
Oliver Schacht, CEO
Max-Eyth-Str. 42
71088 Holzgerlingen, Germany
Tel. +49 (0) 7031 49195-10
pr(at)curetis.com
www.curetis.com

This release was published on openPR.

Permanent link to this press release:

Copy
Please set a link in the press area of your homepage to this press release on openPR. openPR disclaims liability for any content contained in this release.

You can edit or delete your press release Curetis Completes Enrollment for its EU Trial As Planned here

News-ID: 239020 • Views: 1555

More Releases from Curetis AG

Mayo Clinic’s Dr. Robin Patel Named Principal Investigator for Curetis’ Unyv …
− Curetis adds six new trial sites, significantly expanding U.S. clinical trial network for ongoing FDA study Holzgerlingen, Germany, May 14, 2014 -- Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that Robin Patel, M.D., Professor of Medicine and Microbiology at the Mayo Clinic in Rochester, Minn., has been named Lead Principal Investigator of the company’s Unyvero™ LRT Application FDA trial. The lower respiratory tract (LRT) application is
Curetis AG Initiates Clinical Trial in the U.S. Towards FDA Clearance
- Prospective Multi-Center Trial to Enroll Over 2,000 Clinical Samples - Holzgerlingen, Germany, December 6, 2012 -- Curetis AG today announced the start of a clinical trial of its Unyvero™ System and the corresponding LRT (lower respiratory tract) application in the U.S. The company expects enrollment completion within the next 12-15 months, followed by a 510(k) submission to the FDA in 2014. The prospective, multicenter trial will include samples collected from more
Curetis and Scholz Collaborate to Industrialize and Scale-Up Production of Unyve …
- German family firm ‘Scholz-HTIK – High Tech in Kunststoff’ has been selected by Curetis based on systematic benchmarking process - Holzgerlingen (Germany), December 4, 2012 -- Curetis AG today announced a strategic supply chain partnership with German family business Horst Scholz GmbH + Co. KG for the production of high-quality plastics parts for its Unyvero™ Cartridge. Under the agreement, Curetis will invest more than € 2 million in multi-cavity tools for
Curetis AG Signs Up BioLine LLC as Exclusive Distribution Partner for Russia
- Partners to start registration process and market launch in Russia - Holzgerlingen, Germany, September 27, 2012 -- Curetis AG today announced that it has signed up BioLine LLC as an exclusive distribution partner for Russia, Ukraine, Kazakhstan and Belorus. BioLine is a major player in these markets and distributor for global companies such as Becton Dickinson, Leica Microsystems and many others. BioLine is preparing the registration of the Unyvero™ Solution and

All 5 Releases


More Releases for Unyvero

Mayo Clinic’s Dr. Robin Patel Named Principal Investigator for Curetis’ Unyv …
− Curetis adds six new trial sites, significantly expanding U.S. clinical trial network for ongoing FDA study Holzgerlingen, Germany, May 14, 2014 -- Curetis AG, a developer of next-level molecular diagnostic solutions, today announced that Robin Patel, M.D., Professor of Medicine and Microbiology at the Mayo Clinic in Rochester, Minn., has been named Lead Principal Investigator of the company’s Unyvero™ LRT Application FDA trial. The lower respiratory tract (LRT) application is
Curetis AG Initiates Clinical Trial in the U.S. Towards FDA Clearance
- Prospective Multi-Center Trial to Enroll Over 2,000 Clinical Samples - Holzgerlingen, Germany, December 6, 2012 -- Curetis AG today announced the start of a clinical trial of its Unyvero™ System and the corresponding LRT (lower respiratory tract) application in the U.S. The company expects enrollment completion within the next 12-15 months, followed by a 510(k) submission to the FDA in 2014. The prospective, multicenter trial will include samples collected from more
Curetis AG Signs Up BioLine LLC as Exclusive Distribution Partner for Russia
- Partners to start registration process and market launch in Russia - Holzgerlingen, Germany, September 27, 2012 -- Curetis AG today announced that it has signed up BioLine LLC as an exclusive distribution partner for Russia, Ukraine, Kazakhstan and Belorus. BioLine is a major player in these markets and distributor for global companies such as Becton Dickinson, Leica Microsystems and many others. BioLine is preparing the registration of the Unyvero™ Solution and
Curetis AG Chooses Mediphos as Exclusive Distribution Partner for the Netherland …
- Partners prepare market launch and clinical evaluation project - Holzgerlingen, Germany, September 26, 2012 -- Curetis AG today announced that Curetis and Mediphos have closed an exclusive distribution agreement for the Netherlands. Mediphos is an experienced independent distributor with a clear focus on molecular diagnostics and an emphasis on microbiology-based applications. Under the agreement, both companies will prepare the market roll-out of Curetis´ Unyvero™ Solution and the Unyvero™ P50 Pneumonia
Curetis and Heraeus Medical Collaborate on the Development of New Unyvero™ Dia …
- Joint development of cartridge for orthopaedics, wound and surgery infections - Holzgerlingen and Wehrheim (Germany), September 20, 2012 -- Curetis AG and Heraeus Medical GmbH have signed a collaboration agreement to jointly develop a novel Unyvero™ cartridge for the detection of pathogens and antibiotic resistances in implant & tissue infections (ITI). One key application area will be in orthopaedics, e.g. to diagnose infections after knee and hip replacement surgeries. Under
Curetis AG Achieves CE-Marking for Unyvero™ Solution and Initiates Commerciali …
- Successful completion of performance evaluation study; CE Mark for Unyvero™ instrument system and pneumonia application - Holzgerlingen, Germany, May 14, 2012 -- Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced that the company has achieved the CE marking for its Unyvero™ suite of instruments and the P50 Pneumonia Cartridge and that is has already initiated national