By Ben Butkus
German startup Magna Diagnostics is leading the charge to develop a point-of-care molecular testing platform based on magnetic nanoparticles and PCR amplification under a three-year grant from the German government that is worth at least €1 million ($1.32 million), PCR Insider has learned.
Leipzig-based Magna, a recent spinout of Germany's Fraunhofer Institute of Cell Therapy and Immunology, is spearheading a public-private consortium that includes two different Fraunhofer Institute branches, Siemens, and several smaller companies. The goal is to produce a prototype device for clinical testing by early 2013, Magna CEO Christian Zilch said this week.
The device, dubbed Mazer, will rely on a phenomenon known as tunnel magnetoresistance, or TMR, a magnetoresistive effect that has been used in computing for hard disk drives and newer memory applications, but which is also useful for various sensing applications.
Mazer will use nanometer-scale magnetic beads that can be industrially manufactured and functionalized by attaching biological capturing molecules. The functionalized magnetic beads can bind to target cells or molecules and subsequently be automatically transported by magnetic force through various reaction chambers on a plastic card.
The various reaction chambers will then perform the steps necessary for molecular diagnosis, including purifying a blood sample, isolating cells from the sample, isolating DNA from the cells, PCR amplification, and target detection. According to Magna, at the end of the analysis, a highly sensitive magneto-sensory element is used to make the final diagnostic determination. As such, the plastic consumable card will be inserted into a handheld instrument with a readout display.
Currently, the Mazer system uses endpoint PCR, and specific primers and molecular assays will be designed by the Fraunhofer Institute of Cell Therapy and Immunology, or Fraunhofer IZI, in Leipzig, Zilch said. However, the group is examining a host of other amplification technologies, such as rolling circle amplification, he added.
Magna claims that Mazer will be able to detect and quantify several molecular targets simultaneously in as little as 30 minutes to an hour. Furthermore, the various components of the device will be relatively inexpensive to manufacture, and the platform will have a small laboratory footprint and will be easy to use, making it ideal for use at the bedside in hospitals and physicians' offices, Magna said.
The effort to develop Mazer officially kicked off in May 2010 when Magna and partners won a three-year grant from the German Federal Ministry of Education and Research, or BMBF.
"We are coordinating the BMBF project, which will go to April 2013, at which point we will have a functional prototype," Zilch said. "This prototype will then be tested in a clinical environment, to give you an idea of how long it will take to get this to market."
Zilch declined to provide the exact amount of funding received from BMBF; however, he said that the total project has a budget of about €2.2 million, approximately half of which will be provided by the agency.
Because Mazer will combine several different technologies on one platform, Magna has enlisted the assistance of a number of public and private partners.
First and foremost, Magna is working with Siemens, which has expertise and intellectual property rights surrounding the TMR magnetic bead technology.
"We will have the basic patents for this device, and within the framework of this program there will probably be more patents arising," Zilch said. "However, the basic patents we have licensed from Siemens, which is currently a subcontractor for the chip development."
In an e-mail to PCR Insider, Manfred Rührig, a senior research scientist at Siemens Corporate Research and Technologies, confirmed that his laboratory's role is to assist Magna in the development of the underlying basic sensor hardware.
"Magna Diagnostics' goal is to use TMR sensors to detect the presence of magnetic beads in functionalized areas on a read-out chip, which forms an essential part of the platform," Rührig said. "Based on our expertise in highly sensitive TMR sensors — which we have developed for a variety of non-medical applications in the past — Dr. Zilch has asked us to participate in his consortium at this early development stage."
Other consortium partners include German microelectronics shop Danube Integrated Circuit Engineering, or DICE, and the Austrian Institute of Technology, both of which will assist with chip design and development. In addition, Jena-based Microfluidic ChipShop will contribute design and development of the microfluidics components of the plastic consumable, Zilch said.
Magna's role in the project is to coordinate the integration and assembly of Mazer's various technology components and conduct the requisite preclinical testing before moving the device into clinical testing. Zilch said that Magna has a close relationship with the Fraunhofer Institute, and that the institute's Assembly and Packaging Technologies branch, Fraunhofer IZM, will assist Magna with device integration and prototype development.
Finally, clinical trial consulting firm and Magna parent company Bioville, also based in Leipzig, is providing an unspecified amount of funding to support the project.
Zilch said that the initial diagnostic focus for Maser will be sepsis, although the consortium will also be eyeing a variety of other infectious disease areas.
"There is quite a large spectrum of organisms involved with sepsis infection," Zilch said. "They can range from 25 to 35 different pathogens. Currently, in our model assays, we are focusing on the most important ones, especially Staphylococcus aureus and E. coli. But this is just for our model assays, and we are developing assays for a much broader variety of pathogens."
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