NanoLogix rapid diagnostic technologies to enter market under FDA 510K-exempt status

Aug. 30, 2012

NanoLogix has announced it will begin commercialization of its BNP (BioNanoPore) and BNF (BioNanoFilter) diagnostic kits under FDA 510K-exempt status. The first product to be marketed will be the Petri-based BNP detection kit utilizing TSA media. Other nutrient media will be available by special order. Recently completed independent third-party research has demonstrated BNP diagnostic kits to be two to ten times faster at live bacteria detection than traditional methods. Following the BNP rollout, NanoLogix plans to commercialize its BNF technology, which third-party research documents as 18 to 72 times faster than conventional detection and identification methods. The company also plans to develop customized test kits for particular applications and client partners.

The results of an independent third-party research study using NanoLogix technology showed details of the use of NanoLogix BNF test kits and final results of a 356 pregnant-patient Group B Streptococcus (GBS) clinical study at the University of Texas Health Science Center—Houston. This study attained GBS detection, identification and antibiotic-sensitivity results from samples collected in as little as 6 hours, as opposed to traditional laboratory test times of 48 to 72 hours. One major goal in the study was to ensure the ability to test for antibiotic sensitivity in reduced time from the standard, potentially enabling physicians to rapidly tailor antibiotics to the specific infection involved and reduce the overuse of broad spectrum antibiotics. Traditional culture delivers results in 21 in 28 days. Learn more about GBS, its dangers, and how it is being combated.

Photo 103483727 © Splank |
Photo 167576138 © calypsoArt |
Photo 11175251 © Alexey Rodionov |