Tessarae, an array firm based in Sterling, Va., recently began rolling out its debut array for multiplex pathogen detection to existing to reach out to independent testing labs.
Using Affymetrix's high-density array platform, the company's TessArray Resequencing Pathogen Microarray, or TessArray RPM version 3.0 Flu, contains probes for more than 30 different pathogens and bacteria related to influenza, adenovirus, and coronavirus.
While the number of ready-to-go pathogen-detecting arrays increases annually, Tessarae says its strategic advantages are two-fold. First, it uses Affy's higher density arrays to provide enough sequence information to detect known and unidentified pathogen strains as well as to characterize any variants.
Secondly, the firm said its multi-pathogen-detection chip sets it apart from other efforts, such as those at the University of Colorado, Boulder and and the Weizmann Institute of Science in Israel, that have focused on one disease per chip, such as influenza or severe acute respiratory syndrome (see BAN 12/6/2006, BAN 3/14/2006).
According to Tessarae chief technology officer Clark Tibbets, the company's decision to move the platform from a government research project to a private company last year was spurred by advances in the technology and by outbreaks of SARS, avian flu, and other diseases that underscored the company's belief that a multi-pathogen chip was the best way to reach the market.
"We decided we needed an array that could help distinguish what was going on in an individual that was presenting with respiratory symptoms and fever," Tibbets told BioArray News this week. "In the first days where we were evaluating cases from a public health standpoint, adenovirus and influenza were the primary culprits but there were also large number of other viruses and bacteria that could cause similar symptoms and this was a way to identify those from a single test."
By the time the company developed RPM 3.0, “the world had experienced the SARS epidemic outbreaks and had started to become concerned about the emerging potential of Avian influenza strains breaking through as a public health threat in human disease," he said.
Tibbets said that RPM 3.0 is designed to perform a forensic examination of any sample, particularly in samples from humans or birds. It has the capability to characterize known as well as unknown isolates.
"We can provide the information as to whether that particular isolate of H5N1 has changed in terms of loci that confer resistance to Tamiflu, or changed in terms of loci that confer virulence to the flu strain, or changed in ways that might be more prone to attack the upper respiratory tract in the human," Tibbets said. "We get all that info simultaneously with the detection event because the detector is a massive array of sequence contextual probes."
Tessarae's chip contains 956,000 probes for 117,000 base pairs for different types of influeza, parainfluenza, coronaviruses, coxsackieviruses, pneumonia, and adenoviruses. According to Matt Lorence, Tessarae's director sales and marketing, the company partnered with Affymetrix in January 2007 as the first member of the 'emerging markets' subclass of its Powered by Affymetrix partnerships — a grouping that also includes Affy's diagnostic partners like Roche, Pathwork Diagnostics, Almac Diagnostics, Epigenomics, and Veridex.
"We are the first 'emerging markets' PBA partner," Lorence told BioArray News this week. "There are other market opportunities that Affy wants to play in but are not in clinical diagnostics. Our mandate now with Affy is to promote this technology for non-clinical use at the moment for epidemiology and public health services.
"Should we choose to go back to them in the future to market it as a clinical diagnostic, that's something we can explore if and when we get US Food and Drug Administration clearance for the device," Lorence added.
Since concluding the PBA agreement with Affy and securing licenses to TessArray's technology from the Naval Research Laboratory in November, TessArray has proceeded to build some early relationships with customers and Lorence says the launch of RPM 3.0 is ongoing.
"It's available now and we've been going out and doing our own sales and marketing efforts, but because the company has only been doing this for two months, these are in its earliest stages," he said.
"Our initial target customers are public health laboratories and similar institutions that need more detailed genotypic information about the bacterial and viral infectious agents causing respiratory disease in their populations," Lorence said. He added that customers should be able to use to the chip to "monitor the spread of such pathogens and detect mutations that may alter their potential to cause a pandemic" and to "assess the risk from biothreat or emergent agents that warrant elevated epidemic or pandemic concerns."
"Our mandate now with Affy is to promote this technology for non-clinical use at the moment for epidemiology and public health services."
Customers can either access TessArray as a catalog product or the company will run the experiments and provide results in house at its facility, Lorence said.
Moving Beyond Government Customers
While Tessarae's multi-pathogen detection approach sets it apart from other companies that have decided to focus on specific conditions like influenza, its entry to the market coincides with CombiMatrix’ and Australia's BioChip Innovations’ promise to have a flu chip on the market in Australia by the end of this year (see BAN 4/3/2007).
This week CombiMatrix announced that it had updated its influenza A microarray product, launched in 2005, to take into account the more than 2,000 new sequences that have been recently released by the Influenza Genome Sequencing Project.
Like Tessarae, Combimatrix has benefited from close ties to the US government. Tessarae's CEO Klaus Schäfer is a former US Air Force Assistant Surgeon General. David Danley, CMBX's director of homeland security and defense programs, is a retired Army colonel and was project manager of the chemical biological medical systems and joint vaccine acquisition program for the Department of Defense before joining CombiMatrix in 2003.
Combi has also seen interest from the government through a continuing stream of revenue, most recently an $869,000 contract from the Air Force Research Laboratory to do further studies on its influenza detection system.
But with so much government interest, are companies like Tessarae and CombiMatrix misgauging the demand for pathogen-detection chips? CMBX CEO Amit Kumar says no.
"Infectious disease testing is not only applicable for military markets, but also for civilian markets," he told BioArray News this week. "The key here is that the military market is a subset of the overall market, but that those in the military are at a greater risk for contracting these diseases."
Kumar added that while his company has always seen a market for its flu chip beyond the immediate one in the military, "the military is funding this work, but the intent is to have projects funded that aren't just designed for military purposes."