In NARMS way

CHELMSFORD, Mass.—Magellan Biosciences is partnering withGermany-based miacom diagnostics GmbH to bring miacom's family of moleculartests to the U.S. and Canadian markets.

Suitable for microbiology labs of all sizes, miacom's familyof 30-minute molecular tests identify sepsis-related pathogens directly fromblood culture bottles, enhancing Magellan's suite of blood culture, microbialidentification and susceptibility test products.

The combined offering will enable clinicians to make moreinformed treatment decisions that improve patient care and help in the globalfight against drug resistance (of which the National Antimicrobial ResistanceMonitoring System, or NARMS, is a part), claims Joel De Jesus, Magellan's vicepresident of business development and marketing. The company's Sensititresusceptibility tests are the system of choice for NARMS.

"Getting patients on the correct antibiotic, in the rightdosage, in the least amount of time, is crucial to both patient health and tocountering the emerging problem of drug resistance," says Magellan Presidentand CEO Dr. Hiroshi Uchida. "By combining rapid miacom identificationtechnology with the flexibility and accuracy of our microbial-detection systemand susceptibility testing, laboratories of all sizes can battle drugresistance with a cost-effective solution for blood culture, identification andsusceptibility testing."

The product suite will include Magellan's TREK-brandVersaTREK microbial-detection system, miacom's lucescoIVD kits for affordable,rapid identification of bacteria and fungi/yeast from blood cultures andMagellan's TREK-brand Sensititre susceptibility-testing system. Pathogens froma positive blood culture on the VersaTREK system can be identified quicklyusing a lucesco IVD kit, with microbial susceptibility determined using theSensititre system.

Under the terms of the agreement, Magellan will be theexclusive U.S. and Canada provider of bacteremia and fungimia panels using themiacom platform. Four miacom diagnostics tests have been approved this year foruse in Europe. Magellan expects to market a family of miacom sepsis testsavailable for research use only in the United States while beginning theclinical trials toward U.S. Food and Drug Administration clearance.

The Magellan-miacom partnership is a result of a change ofdirection at Magellan authored by Uchida in 2010 that resulted in the formationof Trek Diagnostics.

"Phenotypic testing is not going to be replaced by moleculartesting just yet," states De Jesus.

So the search began for a partner who could provideaffordable, rapid identification of pathogens from blood cultures, and byOctober 2010, "miacom bubbled up to the top of the list," De Jesus says.

The miacom assays, which incorporate a next-generationfluorescence in-situ hybridization,yielded multiplex pathogen identification in just 30 minutes. Further, handlingand performance limitations from error-prone washing steps common totraditional techniques are completely eliminated in miacom's proprietarymethod. The workflow is as simple as performing a gram stain and results are availableone to five days earlier than traditional culture methods, the company claims.

All kits are designed as affordable multiplex tests thatdetect up to 14 different bacterial or fungal targets on a single microscopeslide representing about 90 percent of all blood culture results specific tothe U.S. market, De Jesus says, with sensitivity of 95 percent and specificityof 97 percent.

"We are pleased to partner with Magellan to improve patientcare across the globe," says miacom CEO Dr. Mirko Stange. "Unlike most othermolecular technologies, miacom assays can be performed in virtually anymicrobiology laboratory. Doctors no longer have to rely on an empiricalapproach to therapy—the combination of our rapid lucesco IVD results andSensititre susceptibility testing eliminates guess work, enabling clinicians toprescribe the best, most-targeted therapy to their patients as quickly aspossible."

De Jesus notes that there are about 64 million blood culturetests done in the United States annually, and that only about 7 percent arepositive. The Magellan-miacom approach only carries forward with the fourmillion positives and provides rapid results.

"We can answer the questions of 'what's the rightantimicrobial agent, what's the right dose and, finally, did the physicianchoose the right therapy?' And we can do it in 40 hours or less," he says.

Magellan Biosciences partners with Bruker on microbiologytools

CHELMSFORD, Mass.—Magellan Biosciences also recentlypartnered with Bruker Corp. to deliver microbial identification from culturesusing MALDI-TOF proteomic fingerprinting, along with Magellan's TREK-brandsusceptibility tests to clinical, research and veterinary laboratory customers.

Under the terms of the agreement, Magellan will develop andtest an integrated cross-platform software interface that will enable microbialidentification information gathered on the Bruker MALDI Biotyper massspectrometry-based proteomic finger-printing system to be combined withMagellan's Sensititre susceptibility results. The software will allowlaboratories to generate custom expert rules, which can guide laboratory andclinical 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 offeringsare expected to improve the microbiology laboratory workflow, offering fast,reliable results that enable clinicians to make more-informed treatmentdecisions. Prescribing the right antimicrobial drug at the lowest possible doseto eradicate a bacterial, fungal, or yeast infection is not only important tothe specific patient's health, but also critical to the global efforts tocombat the burgeoning problem of drug resistance, the companies said in astatement.

"We can soon combine the MALDI Biotyper's rapididentification of more than 2,000 species of bacteria, as well as yeast andfungi, with Sensititre's true MIC results for an expansive list ofantimicrobial drugs and dilution ranges, enabling physicians to make moreprecise dosing decisions," says Magellan President and CEO Dr. Hiroshi Uchida.

"This arrangement leverages both companies' products andexperience, while providing significant improvements in ease of use andtime-to-results using the MALDI Biotyper for cost-effective, proteomicfingerprint based identification," adds Bruker Daltonics Vice President ofBusiness Development Dr. Gary Kruppa. "Bruker is committed to the OpenMicrobiology Consortium concepts of open interfaces, and of making its systemscompatible with other microbiology products in order to provide the mostadvanced and cost-effective solutions to microbiology customers worldwide."