Diascopic, a Cleveland-based diagnostic technology startup, is using a grant from the U.S. Small Business Innovation Research (SBIR) program to develop a near point-of-care (POC) diagnostic platform for detecting the bacterium that causes tuberculosis (TB).
The platform is initially intended for use in South Africa. Eventually, the technology could be applied to detect other organisms responsible for conditions in other geographies.
Diascopic undertook preliminary studies of its integrated hardware-software diagnostic in five African clinical locations where TB is prevalent. Results were promising enough that the company was able to secure $225,000 in SBIR funding from the National Institutes of Health's (NIH) National Institute of Biomedical Imaging and Bioengineering.
Diascopic's iON platform, which currently is a preproduction version of the final product, combines low magnification and high-resolution imaging with digital analysis software.
"It's a platform technology that integrates an optical reader and proprietary software," Jim Uhlir, vice president of research and engineering, said in an interview. "We trained an algorithm to identify the bacterium that causes TB by reviewing real slides prepared in South African clinics."
The result is a portable, simple, and flexible digital diagnostic platform that allows clinicians to review microscopic specimens almost immediately. The system can detect the bacteria responsible for TB, Mycobacterium tuberculosis, from a single sample in less than 60 seconds. Traditional techniques for detecting TB require highly trained technicians and lab equipment, as well as several hours or days for the results.
The iON image reader weighs about 4 kg, is battery-operated, and connects to a laptop using a USB interface. Slide image analysis is performed within the platform, so there is no need for cloud storage, Uhlir explained.
"The iON could be located in a clinic, in a near-POC setting," he said. "A doctor would get the test results quickly, and if the results are positive, patients could begin treatment immediately. There would be no need for them to return later."
Diascopic intends to use the SBIR funding to evaluate the platform's proprietary coded algorithm against artificial intelligence (AI) software -- and a hybrid of both -- to determine which performs better and is more accurate, Uhlir said. Some of the money will also be used to tweak the software and create a master image database consisting of up to approximately 60,000 digital images from 400 specimens. Toward this end, Diascopic is working with the Uganda-Case Western Reserve University (CWRU) Research Collaboration, a partner on the SBIR grant, to collect the specimens.
Uhlir and CEO Cary Serif indicated the company intends to commercialize the platform within six months to a year. Diascopic plans to apply for additional SBIR funding to be used toward commercialization.
The optical reader and software are designed to be adaptable to other organisms, Serif noted.
"While the iON will be initially used in Africa for TB, we will be examining its potential use to detect other diseases, such as malaria and cervical cancer," added Uhlir.
The company is exploring paths for introduction in the U.S.
"Our discussions with them [the U.S. Food and Drug Administration (FDA)] indicate that the iON would be considered a class II device, perhaps even a 510(k) device," Uhlir explained. "But we'll need to reopen discussions with the FDA as we get closer to entering the U.S. market."