Ionian Technologies Inc., a spin-out from the Keck Graduate Institute of Applied Sciences, expects that its molecular diagnostics focus in the not-too-distant future will be used for biothreat detection, and ultimately, for point-of-care diagnostics that could be completed in a physician's office for emerging and existing infectious diseases.

The genetic analysis technology on which the company is based was developed in the laboratory of David Galas at Keck, based in Claremont, Calif.

"Essentially, the initial focus of the young start-up company is in the diagnostics applications," said Ionian CEO Gayle Deflin. "We have sort of two areas that we're focused on in diagnostics and detection: one being infectious disease, and the other is the biothreat detection area."

Deflin continued, "Although one obviously is clinical and the other environmental monitoring, there is a great deal of overlap between the development of both of those applications."

Ionian, of Upland, Calif., was created in March 2002. With six full-time employees today, it still very much relies on Galas' lab for continued research through a licensing and research collaboration.

Galas' laboratory has received funding in the past for the development and demonstration of the technology from the Defense Advanced Research Projects Agency (DARPA). Galas said that the biothreat agents his research has been focused on are, as a requirement, the same as those of the government. However, one of the first things Ionian will be looking at is respiratory infections, both viral and bacterial, including various pneumonia agents, influenza and severe acute respiratory syndrome, or SARS.

"We are working on continuing that contract - developing handheld anthrax detectors," Deflin said. She added that the company "recently began development of assays in [the diagnostic area] and continues to seek funding for further development of assays that would be applicable in the infectious disease market." In that market, they would like ultimately to develop a point-of-care diagnostic.

Ionian is probably two to three years away from trials that could result in FDA approval of diagnostic tests, Deflin said.

The science on which the company is based "will replace PCR [polymerase chain reaction]" technology, Galas said.

Another critical point, Galas said, is that the isothermal nature of the reaction allows it to occur at a molecular level in test tubes. That means that the person conducting the test really doesn't have to do anything.

"You just hold it at the right temperature, and it will go to completion in just a few minutes," he said.

The technology allows looking for multiple pathogens in the same reaction in the same sample, Deflin said, which is one of the superior features of the technology. Because it's isothermal, or operates at one temperature, it requires less complicated instrumentation. For example, she said the user simply looks at "a portable, handheld, battery-operated instrument that runs the reaction."

Also, the technology works directly on RNA, which Galas said "makes it absolutely unique among any approach." He added that it is an example of the marriage of diagnostics and therapeutics applications.

When looking at that marriage, two things have to happen, Galas told BioWorld Today.

"One, we have to know enough to know what to diagnose, what kind of information to get, and secondly, we [need] the technology to make it reliable and quick and easy to do," Galas said.

Deflin added, "This will give the physician the tools to properly prescribe appropriate treatment."

Also, Ionian's technology will allow for the identification of strains of pathogens, an important issue in antibiotic resistance.

Galas has long been known for his work in genetics, having served as president and chief scientific officer of Seattle-based Chiroscience R&D Inc., a company formed through the acquisition of Darwin Molecular, which Galas co-founded. Prior to that, he served as director for Health and Environmental Research at the U.S. Department of Energy's Office of Energy Research from 1990 to 1993, where he was responsible for all life sciences research funded by the department, including its component of the Human Genome Project.

Recently, Ionian has attracted one of life sciences' most visible players, Craig Venter, president of the J. Craig Venter Science Foundation in Rockville, Md., and former president and chief scientific officer of Celera Genomics Group, also of Rockville, to serve on Ionian's board.

The company has raised about $3.5 million, but plans to seek additional funding in the range of $5 million to $10 million "over the next few years," Deflin said.