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NanoLogix Announces European Clinical Trial of Its Rapid Detection Kits

NanoLogix, a biotechnology innovator in the rapid detection and identification of live-cell bacteria and microorganisms, announced today its BioNanoFilter (BNF) technology will undergo a clinical trial, led by Dr. Gian Carlo Di Renzo of the University of Perugia in Italy. The 300 patient trial will study the speed and accuracy of NanoLogix technology compared to current methods in the detection and identification of Group B Streptococcus (GBS) in pregnant women. Initial BNF results on GBS from the University of Texas Health Science Center-Houston show detection and identification within two to six hours. This is eight to twenty-four times faster than conventional methods. The trial will be the second clinical trial conducted on the NanoLogix BNF technology for Group B Strep. Results from this clinical trial will accelerate the approval of the BNF kits for use in Europe, North Africa and the Middle East.

Conventional technology can take at least 48-72 hours to return results for Group B Strep. Often during this waiting period it is recommended that physicians treat patients empirically with antibiotics if they fall into specified "at risk" categories for being colonized with GBS. This practice protects the mother from health risks and the unborn child from life threatening illnesses related to Group B Strep. However, it can also lead to the development of antibiotic resistance in GBS strains.

About 30 percent of reproductive age women carry GBS, which can cause life-threatening infections such as sepsis, meningitis and pneumonia in newborns, if their mothers are not treated prior to delivery. In the U.S., delivery without treatment results in around 8,000 newborns being infected each year. The Centers for Disease Control guidelines for the prevention of neonatal GBS call for testing all pregnant women for GBS between 35 and 37 weeks. In 2009, just over 4 million women gave birth in the U.S. alone.

"We are excited to have our BioNanoFilter technology undergo a clinical trial in Europe," said NanoLogix CEO Bret Barnhizer. "We expect this European clinical trial to pave the way for certification and validation of our rapid detection technologies there, as well as in North Africa and the Middle East. We thank Dr. Di Renzo and the other physicians and technicians who are involved in the trial."

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