Magellan Biosciences, a global manufacturer of products designed to make diagnostic testing easier, more cost-effective, and less labour intensive, announced an agreement with Bruker Corporation to deliver microbial identification from cultures using MALDI-TOF proteomic finger-printing, along with Magellan’s TREK-brand susceptibility tests to clinical, research, and veterinary laboratory customers.

The compatible product offerings are expected to improve the microbiology laboratory workflow, offering fast, reliable results that enable clinicians to make more-informed treatment decisions. Prescribing the right antimicrobial drug at the lowest possible dose to eradicate a bacterial, fungal, or yeast infection is not only important to the specific patient’s health, but also critical to the global efforts to combat the burgeoning problem of drug resistance.

Under the terms of the agreement, Magellan will develop and test an integrated cross-platform software interface that will enable microbial identification information gathered on the Bruker MALDI Biotyper mass spectrometry-based proteomic finger-printing system to be combined with Magellan’s Sensititre susceptibility results. The software will allow laboratories to generate custom expert rules, which can guide laboratory and clinical action upon receipt of results from both systems. Magellan’s US microbiology sales force will then promote the complementary product offerings.

“We are pleased to offer these enhanced microbiology tools that will deliver complete, actionable information to improve patient care and fight deadly drug resistance,” said Magellan president and chief executive officer Hiroshi Uchida, PhD. “We can soon combine the MALDI Biotyper’s rapid identification of more than 2,000 species of bacteria, as well as yeast and fungi, with Sensititre’s true MIC results for an expansive list of antimicrobial drugs and dilution ranges, enabling physicians to make more-precise dosing decisions. In fact, Sensititre is the standard used by the National Antibiotic Resistance Monitoring System (NARMS) in the US and Canada,” Dr Uchida added.

The MALDI Biotyper is available in a clinical version with an IVD-CE mark in the European community, and is labelled research-use-only in the United States. Bruker plans to seek US FDA clearance, and regulatory clearance is underway in several other countries. The Sensititre product line features both EU and US clearances, while Japan clearance for the Sensititre system is in process.

“This arrangement leverages both companies’ products and experience, while providing significant improvements in ease of use and time-to-results using the MALDI Biotyper for cost-effective, proteomic fingerprint based identification,” commented Bruker Daltonics Vice President for Business Development, Gary Kruppa, PhD. “Bruker is committed to the Open Microbiology Consortium concepts of open interfaces, and of making its systems compatible with other microbiology products in order to provide the most advanced and cost-effective solutions to microbiology customers worldwide.”

Bruker’s dedicated MALDI Biotyper solution enables molecular identification, taxonomical classification or dereplication of micro-organisms like bacteria, yeasts and fungi. Classification and identification of micro-organisms is achieved reliably and fast using proteomic fingerprinting with high-throughput MALDI-TOF mass spectrometry. Applications include clinical routine microbial identification, environmental and pharmaceutical analysis, taxonomical research, food and consumer product processing and quality control, as well as in marine microbiology. Bruker's robust MALDI Biotyper method requires minimal sample preparation efforts and offers low cost per sample. The MALDI Biotyper is available in a research-use-only version, as well as in an IVD version according to the EU directive EC/98/79 in certain EU countries.

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.

Magellan’s innovative technologies make diagnostic testing easier, more cost-effective, and less labour intensive. The company’s products deliver the timely information that clinicians need to make appropriate treatment decisions and improve outcomes for patients.