This article, which was originally published on Nov. 5, has been updated from a previous version to include comments from Northrop Grumman and Agilent.
By Ben Butkus
Northrop Grumman said last week that it is developing a PCR-based diagnostic system to detect whether a person has been exposed to a biological threat under a $9.6 million contract from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority.
The platform will be based on MassTag PCR, a technology developed at Columbia University and now owned by Agilent Technologies. As such, Northrop Grumman is developing the platform in collaboration with Agilent and Columbia, as well as other partners, the company said.
Under the contract, which was originally announced in September along with seven other BARDA contracts for medical countermeasure innovation, Northrop Grumman will design, assemble, and test two prototypes of a platform called BioCHAMP-RSP, which stands for "Confirmation of Harmful Agents by MassTag PCR – Rapid Screening Platform."
The system will be designed to simultaneously identify more than 30 pathogens, both bacterial and viral, from human samples in a matter of hours, Northrop Grumman said. In an interview this week with PCR Insider, David Tilles, director of homeland security and chemical, biological, radiological, nuclear, and explosives defense at Northrop Grumman, said that the company is heavily focused on biodetection and biosurveillance, and that this latest project is an element of that overall strategy.
"The focus of this is really to provide high-throughput, simple, automated detection" that can then guide first responders in how best to rapidly triage people who have been exposed to biological threats, Tilles said.
In addition, the prototype version will "provide the necessary insight into further development of the technology in subsequent stages, which may lead to a commercial system," Northrop Grumman said in a statement.
MassTag PCR was developed by Ian Lipkin and colleagues at the Center for Infection and Immunity at Columbia University's Mailman School of Public Health. The technique involves attaching small-molecule tags with known molecular weights, called MassCode tags, to DNA primers, and performing PCR amplification on targets using the conjugates.
After removal of unincorporated primers, the tags are released by UV irradiation and analyzed by mass spectrometry. Using this approach, up to 30 different target sequences have been identified simultaneously in a single assay.
Columbia University owns the original intellectual property; however, at some point Eurofins MWG Operon, a division of the Eurofins Group, obtained a stake in the patent portfolio. Then, in November of last year, Agilent Technologies acquired all assets related to the MassCode technology for an undisclosed amount to sell to the basic research market and to develop infectious disease screening panels. As part of that deal, Agilent inked a contract with Eurofins MWG Operon to manufacture the conjugated MassCode tags (PCR Insider, 12/3/2009).
Thus, as part of the BARDA-funded project spearheaded by Northrop Grumman, both Agilent and the Lipkin lab at the Center for Infection and Immunity at Columbia University's Mailman School of Public Health will provide certain expertise related to the MassTag PCR technology.
"Columbia is where a lot of this technology was originally developed … and they are engaged as a technology partner on this both from the standpoint of doing the technology transfer from their lab; as well as being responsible for the panel development," Danielle Dickinson, BioCHAMP product manager at Northrop Grumman, told PCR Insider.
"And Agilent recently bought the MassCode tag technology, so they are involved both as a reagent supplier, and will be responsible for the mass spec component on the back end," Dickinson said.
Roger Lankford, a product manager at Agilent, told PCR Insider that Agilent will also be providing software support in the form of "a graphical-user interface that will allow the end user … a non-mass spec specialist … to set up, run, and do the analysis for these assays."
Lankford added that Agilent will also be providing "reagents to extract the target nucleic acids; reagents to do the actual PCR amplification for the tagged primers; the reverse transcriptase component for RNA viruses and targets; and then the mass spec reagents to run on the mass spectrometer."
Lankford also said that Agilent has thus far been supplying MassCode tag primers to various academic research labs; but has begun collaborations with undisclosed partners to develop its own respiratory molecular diagnostic panels.
"We did acquire the complete rights to the technology last year," Lankford said. "Agilent Labs was also working initially with Columbia on this; and we transferred the tech to [our] R&D group to initiate product development activities. When the BARDA contract came along, we had already become familiar with the technology, so it was natural for us to be a reagent supplier under that contract."
Other parties collaborating on the project include the the Wadsworth Center of the New York State Department of Health, which will be "performing verification testing;" and clinical research organization KAI Research, which "is the smallest piece of this … and will begin some of the work that needs to be done for getting this through the [US Food and Drug Administration] process," Northrop Grumman's Dickinson said.
Dickinson also said that the current BARDA contract lasts one year, and that there is the possibility of winning an add-on contract to continue funding commercial development of the platform, which will likely be a multi-year task.
Northrop Grumman and its partners will be facing stiff competition in the area of PCR-based molecular testing for biodefense. For instance, Idaho Technology last year won $3.3 million from the US Department of Defense to develop rapid tests for a number of pathogens that cause infectious diseases on its FilmArray pathogen detection system, which integrates sample preparation, PCR amplification, detection, and analysis.
In addition, ZyGem and Lockheed Martin recently announced that they are collaborating to develop a "sample-to-answer" DNA-analysis system based on microfluidics and infrared PCR for law enforcement, homeland security, and defense applications (PCR Insider, 9/23/10).
And in September 3M was awarded approximately $6 million in the same round of BARDA funding under which Northrop received its award. The exact nature of 3M's project has not been disclosed, but it is known that the company has been working with Focus Diagnostics to develop tests for seasonal influenza A, influenza B, and respiratory syncytial virus to run on 3M's Integrated Cycler platform (PCR Insider, 8/26/10).
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