NanoLogix, a biotechnology company specializing in the rapid detection of harmful bacteria, is all set to bring its BioNanoFilter (BNF) and BioNanoPore (BNP) diagnostic kits to the market under FDA 510K-exempt status.
The Petri-based BNP detection kit will be the first product to be commercialized using TSA media. Other nutrient media will be offered upon special order. According to recently concluded independent third-party research, BNP diagnostic kits are 2-10 folds quicker in detecting live bacteria when compared to conventional techniques.
NanoLogix plans to introduce its BNF technology to the marketplace following the rolling out of its BNP technology. As per third-party research documents, BNF technology is 18-72 folds quicker when compared to traditional detection and identification techniques. NanoLogix also intends to develop tailored test kits for client partners and specific applications.
NanoLogix will also start sales of traditional TSA Petri plates. The company will offer its TSA Petri plates and BNP kits in its proprietary inert-gas charged vacuum Flat Packs. According to a key third-party laboratory, these Flat Packs have demonstrated shelf life of one year when stored under standard conditions, compared to conventional Petri plates’ three-month shelf life.
The two independent third-party organizations have submitted their study results utilizing NanoLogix technology to key peer-reviewed medical technology journals for publication. The first submission describes the utilization of NanoLogix BNF test kits and final results of a Group B Streptococcus (GBS) clinical trial involving 356 pregnant patients conducted at the University of Texas Health Science Center - Houston. The second submission discusses the results of NanoLogix BNP test kits five-day detection of live Tuberculosis. Conventional culture takes 21-28 days to deliver results.