By Ben Butkus
Mesa Tech, a recent spinout of Los Alamos National Laboratory, has been awarded a $300,000 Phase I Small Business Innovation Research grant from the National Institutes of Health to develop an instrument-free, low-cost, and rapid nucleic acid testing device for multiplexed diagnosis of respiratory diseases, PCR Insider has learned.
The company, which is currently in the prototype-development stage, will likely initially target the global diseases surveillance market, but also envisions optimizing the technology for use in point-of-care diagnostics, particularly in resource-poor areas of the world, Hong Cai, a Mesa Tech co-founder and principal investigator on the grant, told PCR Insider.
"For point-of-care applications, we may have a small handheld instrument that would be extremely inexpensive, well under $100; and then we can make a disposable cartridge that is highly affordable," Cai said.
"But if there were a pandemic for SARS or avian influenza … that requires the whole thing to be disposable, that's OK too," she added. "You could dispose of both the instrument and cartridge if it were a really inexpensive diagnostic device, all about the size of a cell phone."
Mesa Tech's proposed device will be based on technology developed by Cai and colleague Bruce Cary while they were researchers at LANL, which licensed the tech back to the company in exchange for an undisclosed financial stake, Cai said.
The new technology will also use as a stepping stone previous work conducted by Mesa Tech under an $82,000 grant awarded under the American Recovery and Reinvestment Act of 2009. Under that grant, Mesa Tech began developing the consumable portion of the platform, an inexpensive nucleic acid "dipstick" device about the size of a ball-point pen and capable of detecting and distinguishing multiple flu-like pathogens in less than 60 minutes using isothermal amplification and colorimetric detection techniques.
"At that stage we were really developing the chemistry," Cai said. But with the most recent SBIR Phase I grant, administered by the National Institute of Allergy and Infectious Diseases, "we're really trying to integrate the sample prep and all the amplification and detection pieces into one simplified device that would minimize user intervention," she added. "Basically we're trying to have a sample-to-result device that can produce a result in an hour, and the whole thing would be disposable for pandemic and defense purposes."
According to the grant's abstract, Mesa Tech's technology would have an option to be powered by a 9-volt battery for use in resource-limited settings. The device would also be suitable for high-volume manufacturing, "allowing rapid production of millions of units to meet surge capacity during a pandemic outbreak," the abstract states.
Key enabling technological components include the aforementioned isothermal amplification and colorimetric detection, along with chromatography-based sample prep, lateral flow technology, and microheating elements.
In addition to supporting prototype development, the SBIR grant is expected to fund the development of lyophilized amplification and detection reagents suitable for storage in ambient conditions; as well as stable buffer reagents and capsulation methods.
"The primary phase I deliverable is the demonstration of an integrated … prototype that offers a sample-to-answer 4-plex diagnostic test (influenza A and B; respiratory syncytial virus; and RNaseP as a control) complete in 40 minutes," the researchers wrote.
Should they succeed in this goal, Phase II of the project would entail the incorporation of more disease targets, optimization of the manufacture-ready design, production of injection-molded devices, and validation of performance on a large panel of well-characterized samples, according to the grant's abstract.
Myriad companies and academic laboratories are attempting to develop handheld, disposable, point-of-care devices for nucleic acid testing, and most of them use some sort of isothermal amplification technique.
Although Cai declined to share specific details of the company's core amplification technology, she said that it is "really robust and fast compared to other methods of isothermal amplification, which typically take anywhere from 60 to 90 minutes." Examples include nucleic acid sequence-based amplification, loop-mediated amplification, and strand displacement amplification.
Cai added that the amplification strategy was primarily developed at Mesa Tech after it had spun out of LANL.
Once its prototype is completed, Mesa Tech will begin working with outside laboratories to validate the technology. Cai said these would ideally be disease surveillance labs that could also conduct additional testing of the technology on the side.
"The initial step … is to validate our technology, probably in the research and surveillance community, where there is a lower regulatory hurdle," Cai said. "Once we do well with those validation tests, we would be moving out into point-of-care disease diagnostics."
Once Mesa Tech reaches that stage, it would likely look for outside investments to supplement its grant funding.
"Grants are good for initially developing the laboratory prototype through to initial validation," Cai said. "But in terms of really doing product manufacturing, I think we'll be looking for some VC funding."
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