Akonni Biosystems, a biotechnology company developing array-based tests for infectious diseases, recently won a $296,316 grant from the National Institutes of Health to steer its R&D work for the first time towards protein diagnostics, according to company officials.
Chief Scientific Officer Darrell Chandler told BioArray News last week that the grant, entitled “diagnostic protein array for respiratory infections,” is a “protein array project with the goal of being able to detect multiple pathogens in a single test.”
Chandler said that Akonni can use its TruArray platform for both protein and nucleic-acid applications, but that the NIH-funded development is “one of Akonni’s first forays into diagnostics based on a protein array approach.”
The grant brings the total NIH funds awarded to Akonni to $1.99 million. Chandler said that most of the funding helped to develop its diagnostics platform.
“The money is used in a couple of different ways,” he said. “On one hand it is used to develop specific chips or arrays from a commercial perspective; the second thing is to advance the overall platform so that arrays can be used at point-of-care or point-of-use.”
Founded in 2002, Frederick, Md.-based Akonni has set its sights on developing multiple tests for identifying pathogens that cause infectious disease. The firm’s test pipeline includes multiplex assays for detecting multi-drug-resistant tuberculosis; upper respiratory infections such as influenza A; and hospital acquired-infections like methicillin-resistant Staphylococcus aureus.
Kevin Banks, a senior marketing consultant for Akonni, said that the company plans to seek US Food and Drug Administration clearance for one of its assays within the next two years. “Our long-term plans are to build diagnostic applications that have FDA clearance in the time frame of 2010,” he told BioArray News last week.
“Our platform is general-purpose but we have been fine tuning it for specific applications for some time,” said Banks. “We haven't specifically selected the assay; we are looking at hospital-acquired disease and infectious-disease areas and we are trying to figure out which ones we want to take through that process.”
These applications are being designed to run on Akonni’s TruArray platform in an integrated system called TruDiagnosis. Unlike some other array-based test makers, Akonni has opted to develop its own instrumentation platform rather than partnering with an array vendor like Affymetrix or Agilent Technologies.
Akonni’s TruDiagnosis consists of its TruDx 1000 benchtop instrument, its TruSpot v1.0 software for analyzing images and generating reports, as well as TruArray assays for identifying the presence of pathogens using a multiplexed DNA-based approach. The system also includes the company’s TruTip sample-preparation methodology, a three-slide TruArray Hybridization Oven, and a 24-well Piko Thermal Cycler manufactured by Espoo, Finland-based Finnzymes.
“There is a huge global need to provide cost-effective diagnostics, specifically in the area of infectious disease.”
The firm bills its array technology as an alternative microarray approach to those developed from the foundation IP owned and licensed by Affymetrix and Oxford Gene Technology. Akonni’s platform was developed in 1988 by Andrei Mirzabekov, then the director of the Engelhardt Institute of Molecular Biology in Moscow.
Mirzabekov relocated to Argonne National Laboratory near Chicago in 1995, where the array technology was further developed. Akonni estimates that government and private investment in the technology exceeded $22 million by the time the company gained its exclusive license to it in 2002.
Banks described TruArray as a low-density array based on a gel drop technology. “A gel drop is a three-dimensional igloo that contains all probes and chemistry necessary for a reaction,” he said. “We can therefore put more probes into a defined unit of space,” he said.
According to an Akonni fact sheet, the 3D “igloos” that comprise a TruArray probe are typically 100 microns in diameter by 20 microns in height. The firm can manufacture its chips on low-cost substrates, such as plastic. And because it does its own manufacturing, it can switch to lower-cost substrates as it sees fit, Banks said.
Banks added that its probes deliver a “brighter signal” than competitive array platforms, and therefore can use lower-cost optics to detect that signal. For these reasons, Banks said the firm believes that it will eventually be able to sell its product at a lower price point.
“We get a brighter signal and can use lower-cost optics to detect that signal. If you are looking at overall cost of goods, because we get a greater signal and use lower-cost optics, we will be at a lower price point in the market,” he said. Because of the development status of its platform, Akonni declined to discuss pricing for TruDiagnosis.
‘Huge Global Need’
Akonni is not the only company developing array-based tests for infectious-disease identification, though its interest in protein-array technology may eventually set it apart. Different companies have also focused on different diseases for initial applications, though most insist their menus will eventually broaden to offer tests for a variety of conditions.
Among those, Tessarae, a Potomac Falls, Va.-based firm that develops arrays for pathogen identification, earlier this year launched two resequencing microarray assays. Both are designed to run on the Affymetrix GeneChip platform.
Specifically, the company is selling its TessArray RPM-HFV kit, a whole-genome resequencing array for hemorrhagic fever viruses; and the TessArray RPM-TEI Kit, designed to identify tropical and emerging infections (see BAN 7/1/2008).
Meantime, a number of array companies, including CombiMatrix, Veredus Labs, Biochip Innovations, Quidel and others, have instead opted to develop tests for influenza A (see BAN 4/3/2007).
Like these other companies, Akonni has determined that “there is a huge global need to provide cost effective diagnostics, specifically in the area of infectious disease,” Banks said. He also noted that many of the firm’s “primary collaborators” at the US Centers for Disease Control, Columbia University, Argonne National Labs, and the British Columbia Center for Disease Control have “deep expertise” in that area.
“We are leveraging their feedback and competence for the development of our chip,” Banks said. Chandler also cited the extensive links between the 33 employees of Akonni, most of whom work in R&D, as a factor driving the firm’s interest in developing infectious disease diagnostics.
“Those of us who were with the technology very early on have the specific expertise to engage these early adopters and collaborators,” he said.