Magellan Biosciences 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 VersaTREKsystem 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.”