Tag: infectious diseases
Company News: Curetis and Laboratorios LETI Sign Exclusive Distribution Agreement for Unyvero™ in Spain and Portugal
– Five-year agreement based on extensive health economic assessment –
Curetis AG today announced that the company has closed an exclusive distribution agreement in Spain and Portugal with Laboratorios LETI, which includes all existing and future Unyvero™ instruments and consumables. LETI is a biopharmaceutical company based in Tres Cantos, near Madrid, Spain. Its diagnostics business unit distributes and markets a broad portfolio of in vitro diagnostics (IVD) and research products, among other offerings.
The agreement, effective January 1, 2014, was finalized following positive market feedback and favorable outcome of a joint, extensive health economic assessment which included four major hospitals in Spain and Portugal. The commercial launch of Unyvero™ in this region is expected in the first quarter of 2014.
For the implementation, Curetis will provide Unyvero training, marketing materials and supporting health economic research. LETI will manage all marketing and sales activities as well as storage and logistics support. The partners are targeting a market share of more than 50 percent of relevant hospitals and ICU units in the region within the next five years.
Company News: Curetis AG Initiates Clinical Trial in the U.S. Towards FDA Clearance
– Prospective Multi-Center Trial to Enroll Over 2,000 Clinical Samples –
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 than 2,000 hospitalized patients suspected to have a lower respiratory tract infection and several hundred retrospective samples with known microbiology culture results for rare pathogens. Samples will be processed by the Unyvero™ Lysator, transferred to the LRT cartridge, and tested by the Unyvero™ Analyzer.
Primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity compared to microbiology culture (today’s diagnostics standard of care) and to a composite reference diagnosis that incorporates PCR and sequencing to determine clinical truth whenever microbiology culture results are negative.
Trial sites include Northwestern University (Chicago, IL) and North Shore-LIJ Health System (Lake Success, NY), among others. The Principal Investigator is Prof. Christine C. Ginocchio, Senior Medical Director and Chief, Division of Infectious Disease Diagnostics, North Shore-LIJ Health System. Curetis has contracted Aptiv Solutions as its CRO and Neil Mucci of GlobalBioclinical as project manager in the US.
The LRT application analyzes 39 DNA targets simultaneously from a single patient sample. Results are available within about 4 hours. The pathogen panel has been selected for clinical relevance based on current international clinical guidelines and has been reviewed by clinical experts in Europe and the USA. Resistance genes were chosen by frequency and clinical significance. A similar product, the Unyvero™ P50 pneumonia cartridge is CE-marked and currently marketed in Europe and the Middle East.
Company News: Curetis and Scholz Collaborate to Industrialize and Scale-Up Production of Unyvero(TM) Cartridge Plastics Parts
– German family firm ‘Scholz-HTIK – High Tech in Kunststoff’ has been selected by Curetis based on systematic benchmarking process –
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 all Unyvero™ Cartridge plastics parts. Curetis has already ordered several multi-cavity tools from Scholz. The first tools will be delivered in early 2013.
Scholz has been chosen by Curetis due to its unrivalled experience and expertise in medical device-grade injection molding, its state-of-the-art facilities and equipment as well as its cleanroom manufacturing infrastructure.
Scholz has a long track record and outstanding commitment to total quality management, e.g. regarding the use of CT scanners for quality control of parts. Curetis expects a smooth transition from its previous R&D phase supplier to the serial production and scale-up run by its new partner Scholz.
Company News: Curetis Completes Enrollment for its EU Trial As Planned
– Prospective multi-center trial enrolls 800 patient samples in 7 months-
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.