Magellan Biosciences and Germany-based miacom diagnostics have partnered to bring miacom's family of molecular tests to the US and Canadian markets.
The product suite will include Magellan’s TREK-brand VersaTREK microbial-detection system and TREK-brand Sensititre susceptibility-testing system and, miacom’s lucesco IVD (in vitro diagnostic) kits for identification of bacteria and fungi/yeast from blood cultures.
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.
miacom said all lucesco kits enable simultaneous detection of the most-clinically relevant pathogens directly from specimens, and deliver results within 30 minutes.
All kits are designed to 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.
Under the terms of the agreement, Magellan will be the exclusive US 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 US while beginning the clinical trials toward FDA clearance.
miacom CEO Mirko Stange said doctors no longer have to rely on an empirical approach to therapy – the combination of 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.
Magellan president and CEO Hiroshi Uchida said 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.