NanoLogix Inc., an innovator in the accelerated detection, identification and antibiotic sensitivity determination of live bacteria announces that has instructed a third-party to prepare a total of six applications for submittal to the US FDA. The applications are to include:
Results of third-party TB tests for approval for use as a BSL-3 test process for Tuberculosis using NanoLogix BNP technology.
Results of the University of Texas Health Science Center-Houston Group B Streptococcus tests (currently ongoing) for use as a recognized test kit using NanoLogix BNF technology.
Results of multiple third-party tests on gram-positive bacteria with BNP and BNF technologies for approval as recognized tests for the gram-positive family of bacteria.
Results of multiple third-party tests on gram-negative bacteria with BNP and BNF technologies for approval as recognized tests for the gram-negative family of bacteria.
"We are excited to have the process of preparation for FDA submittal moving forward with a third-party," said NanoLogix CEO Bret Barnhizer. "The accuracy of the data and the expertise of the third-party in FDA submittals provides us with confidence that the submittal process will run smoothly and successfully. While it takes the timeline out of our hands, it frees NanoLogix staff and resources to focus on further research and development of our technologies."
Entry Into Food Testing
NanoLogix is currently working with a third-party to develop a unique antibody for Listeria for use in pre-screening food packaging, food processing equipment and preparation surfaces and work areas. Tests of the efficacy of the antibody will occur at client facilities.
Patents Granted and Newly Filed
NanoLogix is pleased to announce it has received two additional patents for its BNC technology. The first is a foundational patent by China. The second (Patent No. US 8,067,154 B2) details how the NanoLogix BNC technology changes the shape of micro-colonies, thus allowing for more rapid detection and counting of cells. The company has multiple patent applications pending in China, India, Brazil, Japan, Russia and Europe for their BNC, BNP and BNF (BioNanoFilter) detection technologies.
In addition, the company this week filed a patent application under the International Patent Cooperation Treaty for a significant addition to its detection technology library.
American Journal of Perinatology Prints Group B Streptococcus Research Using NanoLogix Biotechnology
The peer-reviewed Group B Strep research from the University of Texas Health Science Center - Houston, previously available online, appeared in the November print issue of the American Journal of Perinatology. The research shows NanoLogix BNF test results for viable Group B Strep (GBS) in a total of 4 to 6 Hours. Established in 1983, the journal is the definitive forum for specialists in obstetrics, neonatology, perinatology, and maternal/fetal medicine, with emphasis on bridging the different fields.