NanoLogix Rapid Diagnostic Technologies Set to Enter Market Under FDA 510K- Exempt Status
Third-Party results on accelerated Tuberculosis detection and rapid Group B Streptococcus identification in pregnancies submitted for publication
Hubbard, OH --August 21, 2012-- NanoLogix (OTBB: NNLX), a biotechnology innovator in the rapid detection and identification of live-threat bacteria and microorganisms,announces 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.
NanoLogix is also beginning sales of conventional TSA Petri plates. Both BNP kits and NanoLogix TSA Petri plates will be packaged in the company's proprietary inert-gas charged vacuum Flat Packs. A major third-party laboratory has documented these Flat Packs to have at least a one-year shelf life stored under normal conditions, compared to the 3-month shelf life of traditional Petri plates.
Peer-Reviewed Research Pending Publication The results of two independent third-party research studies using NanoLogix technology have been submitted by their respective organizations to major peer- reviewed medical technology journals for publication.
The first submission details the use of NanoLogix BNF test kits and final results of a 356 pregnant-patient Group B Streptococcus (GBS) clinical study at the HYPERLINK "http://www.uthouston.edu" 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, a sharp contrast to traditional laboratory test times of 48-72 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 actual infection involved and reduce the overuse of broad spectrum antibiotics. For more on GBS: http://sites.conversionplanet.com/group-b-strep-awareness/group%20b%20strep/how-rapid-testing-can-change-the-diagnosis-and-treatment-of-gbs
The second submission features data from a major independent laboratory documenting NanoLogix BNP test kits five-day detection of live Tuberculosis. Traditional culture delivers results in 21-28 days.
About NanoLogix, Inc.
NanoLogix is a biotechnology company focused primarily on rapid diagnostics. Its products offer accelerated detection and identification of microorganisms. In addition to medical and homeland security applications, NanoLogix technology is applicable in pharmaceutical, industrial, veterinary and environmental testing. Patents granted to NanoLogix can be used in the areas of applied microbiology, soil microbiology and bioremediation, microbial physiology, molecular biology, pharmacology, pharmaco-kinetics, and antibiotic sensitivity. For more information visit www.nanologix.com.
This press release contains statements, which may constitute "forward- looking statements" within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Those statements include statements regarding the intent, belief or current expectations of NanoLogix, Inc., and members of its management as well as the assumptions on which such statements are based. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those contemplated by such forward-looking statements. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results.