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In NARMS way
CHELMSFORD, Mass.—Magellan Biosciences is partnering with Germany-based miacom diagnostics GmbH to bring miacom's family of molecular tests to the U.S. and Canadian markets.
Suitable for microbiology labs of all sizes, miacom's family of 30-minute molecular tests identify sepsis-related pathogens directly from blood culture bottles, enhancing Magellan's suite of blood culture, microbial identification and susceptibility test products.
The combined offering will enable clinicians to make more informed treatment decisions that improve patient care and help in the global fight against drug resistance (of which the National Antimicrobial Resistance Monitoring System, or NARMS, is a part), claims Joel De Jesus, Magellan's vice president of business development and marketing. The company's Sensititre susceptibility tests are the system of choice for NARMS.
"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," says Magellan President and CEO Dr. Hiroshi Uchida. "By combining rapid miacom identification technology with the flexibility and accuracy of our microbial-detection system and susceptibility testing, laboratories of all sizes can battle drug resistance with a cost-effective solution for blood culture, identification and susceptibility testing."
The product suite will include Magellan's TREK-brand VersaTREK microbial-detection system, miacom's lucescoIVD 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 been approved this year for use in Europe. Magellan expects to market a family of miacom sepsis tests available for research use only in the United States while beginning the clinical trials toward U.S. Food and Drug Administration clearance.
The Magellan-miacom partnership is a result of a change of direction at Magellan authored by Uchida in 2010 that resulted in the formation of Trek Diagnostics.
"Phenotypic testing is not going to be replaced by molecular testing just yet," states De Jesus.
So the search began for a partner who could provide affordable, rapid identification of pathogens from blood cultures, and by October 2010, "miacom bubbled up to the top of the list," De Jesus says.
The miacom assays, which incorporate a next-generation fluorescence in-situ hybridization, yielded 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, the company claims.
All kits are designed as affordable multiplex tests that detect up to 14 different bacterial or fungal targets on a single microscope slide representing about 90 percent of all blood culture results specific to the U.S. market, De Jesus says, with sensitivity of 95 percent and specificity of 97 percent.
"We are pleased to partner with Magellan to improve patient care across the globe," says miacom CEO Dr. Mirko Stange. "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."
De Jesus notes that there are about 64 million blood culture tests done in the United States annually, and that only about 7 percent are positive. The Magellan-miacom approach only carries forward with the four million positives and provides rapid results.
"We can answer the questions of 'what's the right antimicrobial agent, what's the right dose and, finally, did the physician choose the right therapy?' And we can do it in 40 hours or less," he says.
Magellan Biosciences partners with Bruker on microbiology tools
CHELMSFORD, Mass.—Magellan Biosciences also recently partnered with Bruker Corp. to deliver microbial identification from cultures using MALDI-TOF proteomic fingerprinting, along with Magellan's TREK-brand susceptibility tests to clinical, research and veterinary laboratory customers.
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 U.S. microbiology sales force will then promote the complementary product offerings.
According to the companies, 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, the companies said in a statement.
"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," says Magellan President and CEO Dr. Hiroshi Uchida.
"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," adds Bruker Daltonics Vice President of Business Development Dr. Gary Kruppa. "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."