CHELMSFORD, Mass., and DUESSELDORF, Germany, April 11, 2011 /PRNewswire/ -- Magellan Biosciences, a global manufacturer of products designed to make diagnostic testing easier, more cost-effective, and less labor-intensive, is partnering with Germany-based miacom diagnostics GmbH to bring miacom's unique, cost-effective family of molecular tests to the U.S. and Canadian markets. The 30-minute tests identify sepsis-related pathogens directly from blood-culture bottles, enhancing Magellan's suite of blood culture, microbial identification, and susceptibility test products for microbiology laboratories. The combined offering is designed to provide fast, reliable results for laboratories of all sizes, enabling clinicians to make more-informed treatment decisions that improve patient care and help in the global fight against drug resistance.
The product suite will include Magellan's TREK-brand VersaTREK® microbial-detection system, miacom's lucesco® IVD (in vitro diagnostic) kits for affordable, rapid identification of bacteria and fungi/yeast from blood cultures, and Magellan's TREK-brand Sensititre® susceptibility-testing system. Pathogens from a positive blood culture on the VersaTREK system can be identified quickly using a lucesco IVD kit, with microbial susceptibility determined using the Sensititre system. Under the terms of the agreement, Magellan will be the exclusive U.S. and Canada provider of Bacteremia and Fungimia panels using the miacom platform. Four miacom diagnostics tests have already been approved for use in Europe; this year, Magellan expects to market a family of miacom sepsis tests available for research use only in the U.S. while beginning the clinical trials toward FDA clearance.
Commenting on the agreement, miacom's Chief Executive Officer, Mirko Stange, Ph.D., said, "We are pleased to partner with Magellan to improve patient care across the globe. Unlike most other molecular technologies, miacom assays can be performed in virtually any microbiology laboratory. Doctors no longer have to rely on an empirical approach to therapy – the combination of our rapid lucesco IVD results and Sensititre susceptibility testing eliminates guess work, enabling clinicians to prescribe the best, most-targeted therapy to their patients as quickly as possible."
The miacom assays, which incorporate a next-generation fluorescence in situ hybridization, streamline and greatly simplify molecular testing – yielding multiplex pathogen identification in just 30 minutes. Further, handling and performance limitations from error-prone washing steps common to traditional techniques are completely eliminated in miacom's proprietary method. The workflow is as simple as performing a Gram stain and results are available one- to five-days earlier than traditional culture methods.
"Getting patients on the correct antibiotic, in the right dosage, in the least amount of time is crucial to both patient health, and to countering the emerging problem of drug resistance," said Magellan President and Chief Executive Officer Hiroshi Uchida, Ph.D. "By combining rapid miacom identification technology with the flexibility and accuracy of the VersaTREK and Sensititre systems, laboratories of all sizes can battle drug resistance with a cost-effective solution for blood culture, identification, and susceptibility testing."
About the miacom lucesco IVD kits
miacom diagnostics specializes in in vitro diagnostic tests for pathogens causing acute systemic diseases. All lucesco kits enable simultaneous detection of the most-clinically relevant pathogens directly from specimens, and deliver results within 30 minutes. miacom has already commercialized several rapid tests for the European market, including diagnostics for the most-important systemic infectious diseases such as sepsis and pneumonia. All kits are designed as affordable multiplex tests that detect up to 14 different bacterial or fungal targets on a single microscope slide. In addition, miacom offers tests that detect a single pathogen such as S. aureus from a positive blood culture. In this test format, up to four patient probes can be processed on a single microscope slide to facilitate faster batch runs.
About the VersaTREK and Sensititre product lines
Magellan's VersaTREK automated microbial-detection system offers four tests on one system, including detection of bacteria in blood culture and sterile body fluids as well as mycobacteria detection and M. tuberculosis susceptibility testing. The TREK-brand Sensititre product line for susceptibility testing enables labs to test – on a single cost-effective, LIS-compatible system – more FDA-cleared antimicrobial drugs than on any other automated platform against the widest range of non-fastidious and fastidious bacteria and yeasts. This saves microbiology labs from having to use multiple off-line test procedures to obtain accurate susceptibility data. Magellan often gets early access to the latest therapeutics because pharmaceutical companies use the Sensititre system during drug development. The platform is also the system-of-choice for global surveillance initiatives, including NARMS (National Antimicrobial Resistance Monitoring System). We offer a full range of standard and custom Sensititre plates featuring 18- to 24-hour incubation, true MIC endpoints, and on-scale QC ranges, making susceptibility testing a viable procedure for laboratories of virtually any size. For custom dried or reference-method plates, laboratories can specify format and antimicrobic concentrations, selecting from more than 240 agents, including 80+ cleared compounds, to create a plate best-suited for the lab's particular need. Small minimum order quantities allow for better cost and inventory control.
About Magellan (www.magellanbio.com)
Founded in 2004, Magellan's innovative technologies make diagnostic testing easier, more cost-effective, and less labor intensive. The company's products deliver the timely information that clinicians need to make appropriate treatment decisions and improve outcomes for patients. They include LeadCare®-brand rapid point-of-care systems to screen children and adults for lead poisoning; TREK-brand microbiology products for blood culture and susceptibility testing that help in the global effort to prevent MRSA and other drug-resistant infections; as well as Dynex®-brand automated ELISA processing systems for a wide variety of immunoassays – from infectious disease to autoimmune and food-safety testing. Magellan has approximately 290 employees worldwide.
About miacom diagnostics (www.miacom-diagnostics.com)
German-based miacom diagnostics was founded in 2006 with the vision to excel the speed of molecular identification and characterization of microorganisms. The company developed a novel platform for rapid identification of infectious disease-causing organisms, based on proprietary beacon-based fluorescence in-situ hybridization technology (bbFISH) that streamlines and simplifies assay steps, eliminating handling and performance limitations from error-prone washing steps as well as the need for specialized equipment inherent to other molecular methods. The kits enable the simultaneous identification of up to 14 pathogens directly from respiratory secretions or positive blood cultures. Combined with unrivaled speed, the technology provides superior performance versus traditional diagnostic methods.
SOURCE Magellan Biosciences