Diagnostic is approved for research use, and Magellan will start clinical trials for FDA clearance.
Magellan Biosciences will market miacom diagnostics’ molecular tests in the U.S. and Canada. The deal makes Magellan the exclusive provider in both nations of Bacteremia and Fungimia panels using miacom’s platform.
Magellan expects this year to market a family of miacom sepsis tests available for research use only in the U.S., while beginning clinical trials toward FDA clearance of four miacom diagnostics tests approved for use in Europe.
Magellan says the half-hour tests, which identify sepsis-related pathogens directly from blood-culture bottles, will enhance its suite of blood culture, microbial identification, and susceptibility test products for microbiology laboratories.
The product suite will include Magellan’s TREK-brand VersaTREK® microbial-detection system, which combines instrumentation, media, and software; 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.
Miacom says its assays, which incorporate a next-generation fluorescence in situ hybridization designed to simplify molecular testing, yield identification of multiplex pathogens in 30 minutes, with results available one- to five-days earlier than traditional culture methods.
The deal with miacom is the second marketing partnership announced this month by Magellan using its TREK-brand microbial detection system. On Wednesday, Magellan announced an agreement with Bruker to market its MALDI-TOF proteomic finger-printing along with Magellan’s TREK-brand susceptibility tests, to clinical, research, and veterinary laboratory customers.