The Youngstown, Ohio-area company, which develops diagnostics kits for bacteria and other microorganisms that it says are several times faster than traditional methods of detection, currently has no products cleared for commercial sales by the U.S. Food and Drug Administration.
With no 510(k) product clearances from the FDA in hand, NanoLogix sells only to the research market, but that could soon change. CEO Bret Barnhizer is eyeing sales to the food and veterinary industries after — and if — the company passes the appropriate regulatory hurdles.
NanoLogix develops diagnostic kits for a wide variety of bacteria and microorganisms, which includes salmonella, E. coli, listeria, staph, anthrax, spores and mold. Barnhizer expects to receive FDA clearance for diagnostic tests for several families of bacteria within the next few months.
The company’s BioNanoPore and BioNanoFilter technologies involve a proprietary water-permeable cellulose membrane that’s surrounded by a nutrient mix and lays in a petri dish. Bacteria grows on the membrane, which is then transferred to a staining plate, and allows bacterial micro colonies to become visible after about five minutes, according to the company.
“We don’t make anything grow any faster,” Barnhizer said. “The membrane provides the ability for people to see what’s growing much faster.” NanoLogix’s technology is capable of producing visible results in six hours, which Barnhizer says is several times faster than a petri dish alone.
The technology is involved in two ongoing clinical trials — one in the U.S. and one in Europe. In a 300-patient trial, researchers from the University of Texas Health Science Center in Houston are evaluating the technology’s ability to detect and identify Group B Streptococcus (GBS) in pregnant women. GBS is a bacterial infection that can be passed to a woman’s baby during delivery. Initial results from the trial have shown that NanoLogix’s technology detects and identifies GBS within two to six hours, which the company says is eight to 24 times faster than conventional methods. The second 300-patient trial is also evaluating the technology’s ability to detect GBS and is being led by an Italian researcher. The trial is aimed at helping NanoLogix obtain European regulatory clearance to begin selling its products on the continent.