Monday, August 8, 2011
Company’s test closer to FDA approval
By Karl Henkel
A Mahoning Valley biotechnology company with a bacteria-detecting breakthrough is one step closer to Food and Drug Administration approval.
Hubbard-based NanoLogix announced today that The American Journal of Perinatology published a peer-review paper from The Department of Obstetrics, Gynecology and Reproductive Sciences at University of Texas Health Science Center.
The results, based on a 300-person study, back the company’s findings of a quick detection of Group B Streptococcus, or Strep B.
Strep B is a bacterial infection that affects 3 in 10 pregnant women, according to the study, and can be passed on to a newborn through delivery and cause meningitis, pneumonia and stillbirth.
Antibiotic treatment during labor can protect the baby, but doctors are forced to use a broad spectrum of antibiotics, NanoLogix CEO Bret Barnhizer told The Vindicator.
But with NanoLogix’s expedited petri-dish test, Strep B can be detected in four to six hours, enough time for doctors to determine the strain of bacteria and correct antibiotic treatment.
Normal tests can take 24 to 36 hours, Barnhizer said.
Unlike standard petri dishes, NanoLogix’s BioNanoPore kits put microorganisms on a membrane that doesn’t allow fluid to pass through to the cells. The nutrient solution sandwiches the membrane, and the membrane grows.
The membrane is put on a staining solution that shows growth before it can be seen in a standard petri dish.
The published paper calls NanoLogix’s find “easy to use” and “requires minimal additional equipment” other than an incubator.
“We continue to be amazed at both the consistency and reliability of this NanoLogix technology,” said Jonathan Faro, M.D., Ph.D., lead author of the study and assistant professor in General Obstetrics and Gynecology at UTHSC-Houston. “This validation is just a very large tip of an incredibly enormous iceberg.”
Barnhizer said NanoLogix’s innovation is cost-effective compared with the traditional testing methods. He added it saves time and allows doctors to use specific antibiotics. He calls the breakthrough revolutionary, especially because new antibiotics are not in the pipeline, and antibiotic-resistant bacteria are on the rise.
“No one has anything big that’s going to solve some of the problems that are coming,” he said. “If you can pinpoint what’s needed because you can detect what something is and identify it within six hours ... then you prescribe the specific antibiotic necessary to kill that strain of bacteria.
“Right now, their bodies are essentially being poisoned to kill one bacteria.”
The NanoLogix innovation has been in the works for about three years — and the company has seen similar results testing for E. coli, MRSA, salmonella and other bacteria — but a published paper validates NanoLogix’s claim and makes it a potential candidate for more widespread use.
“We’ve had a number of companies or labs confirm our fast-detection results to us,” Barnhizer said. “But being a little penny-stock company, we could have a cure for cancer with one pill and another pill that would let you live for 300 years disease-free.
“We could have all that and it could be true, but no one would listen to us.”
Barnhizer called the peer review “huge” for NanoLogix in terms of getting FDA approval, which for this project could be a two-to-three month process with the assistance of two subsequent published papers.
“We don’t really know what the future holds other than we know there is going to be huge demand,” said Barnhizer, who said NanoLogix’s 4,000-square-foot facility, behind Emerald Diner on Hubbard’s Main Street, could produce about 50,000 test kits per day.
“We know this is the most efficient way to get test results.”