NanoLogix, Inc. (NNLX)

Uses for NanoLogix's very-rapid diagnostics include biodefense, human and veterinary medicine, processing and safety of food, cosmetics and drugs, research and development, and industrial and environmental testing. Rapid detection of microorganisms is an annual multi-billion dollar market.

NanoLogix has been issued 33 patents in the areas of applied microbiology, soil microbiology and bioremediation, microbial physiology, molecular biology, pharmacology, pharmaco-kinetics, and antibiotic sensitivity.


Mission

NanoLogix is a biotechnology company focused on sale of Petri plates packaged in an exclusive licensed FlatPack and the N-Assay rapid detection technology for bacteria, mold, and spores.

NanoLogix technology is used to test for bacteria and other microorganisms and in some cases, dependent upon the technology used, provide for early detection of bacteria and other microorganisms present in infectious and noninfectious human diseases, the environment, industrial and manufacturing settings, veterinary medicine, and research and testing laboratories.


History

NanoLogix began 26 years ago under the name Infectech. From its founding through 2007 the Company had been issued patents that were in some cases practically, and in other cases theoretically, applicable in the areas of applied microbiology, soil microbiology, medical diagnostics, microbial physiology, pharmacology, pharmaco-kinetics, and determination of antibiotic sensitivity.

In 2007, with a management change, the focus of the company changed from Research and Development to exploring how to capitalize on the company's existing intellectual property. It became obvious that the patents of the past possessed little monetary value for the future and that realization resulted in a further change in direction seeking to focus on practicality in research and a focus on a long term future return for the company and its shareholders. The period from 2007 through 2011 resulted in the abandonment of any focus on the production of hydrogen through bacteria degradation of organic waste utilizing what was referred to as a "bioreactor". The reason for the abandonment of the technology was the discovery of a lack of evidence for any economic potential for the technology. A similar discovery led to the practical abandonment of the NanoLogix BNC (BioNanoChannel) technology. While potentially a novel approach to diagnostics, major-lab third-party tests and a subsequent economic analysis demonstrated that under no conditions could the cost of both the antibody coating and specialized glass microchannel disc contained in the apparatus be reduced to a level to enable effective marketing. Over the following year, NanoLogix went through a transition to production of FlatPack™ Petri plates and BNP™ diagnostic test kits. Sales of both began in Q3 2012.

NanoLogix's rapid diagnostic technology is the N-Assay modified ELISA diagnostic.


NanoLogix Technology

NanoLogix N-Assay technology provides live-cell rapid detection and identification dramatically faster than Flow Cytometry and traditional Petri culture methods. Additionally, in contrast to other fast methods such as Polymerase Chain Reaction (PCR), NanoLogix technology does not require large investments in equipment or personnel training.

Rapid diagnostics allow researchers in the lab to test for potentially pathogenic agents faster and develop effective countermeasures more rapidly and economically. This quality presents exciting opportunities in the pharmaceutical design process, and furnishes the following as benefits:

Can begin more effective drug treatment when an infectious disease is identified at an early stage. The spread of infectious disease may be reduced by earlier intervention.

In combat theaters and homeland security settings, the presence of specific pathogens can be detected closer to the epicenter of release. Site decontamination teams can identify surface samples closer to real time, potentially aiding the field process.

Industrial production—of food, beverage, drugs, or beauty products—can be paralyzed by microbial contamination.  The ripple effect may include expensive recalls, bad publicity, and government mandated "microbiology holds" that delay the replacement of product.  Rapid diagnostics can help minimize the impact by limiting the spread of spoiled product.


Market

The volume of Petri dishes used for traditional tests is millions per day worldwide.

According to Industrial Microbiology Market Review, worldwide industrial microbiology testing is undergoing tremendous growth. The same growth pattern is anticipated in the medical microbiological diagnostics market.

NanoLogix's potential customers are numerous and varied. They include microbiological laboratories in the industrial, medical, environmental, governmental (federal, state and local) sectors, research and development facilities, and educational institutions.


R&D

NanoLogix's research and development continues on other diagnostic technology with variants in the N-Assay currently being developed for one of the world's largest medical device companies.


Research Articles

Development of a Novel Test for Simultaneous Bacterial Identification and Antibiotic Susceptibility
Jonathan Faro,¹ Malika Mitchell,² Yuh-Jue Chen,² Sarah Kamal,² Gerald Riddle,¹ and Sebastian Faro¹

1 The Woman’s Hospital of Texas, 7400 Fannin Suite 930, Houston, TX 77054, USA
2 The University of Texas Health Science Center at Houston, Medical College, Houston, TX 77054, USA

Received 13 May 2016; Accepted 10 August 2016

Abstract 

Background. Elucidation of a pathogen’s antimicrobial susceptibility requires subculture after the organism is first isolated. This takes several days, requiring patients to be treated with broad-spectrum antibiotics. This approach contributes to the development of bacterial resistance. Methods. Microtiter wells were coated with a polyclonal antibody targeting the pathogen of interest. Bacterial suspensions were added in the presence/absence of selected antibiotics. After washing, captured bacteria were detected. Findings. Group B streptococcus (GBS), Enterococcus faecalis, and Neisseria gonorrhoeae were each detected at 10⁵ bacteria/mL following a 20-minute incubation period. Susceptibility to select antibiotics was discernable following a 6-hour incubation period (GBS and Enterococcus). Sensitivity was increased to 10⁻² bacteria/mL for GBS, 10⁻¹ bacteria/mL for E. faecalis, and 10¹ bacteria/mL for N. gonorrhoeae following 18–24-hour culture. Conclusion. This novel assay allows for the highly sensitive and specific identification of a pathogen and simultaneous determination of its antimicrobial susceptibility in a reduced time.


Shelf-Life Assessment of Agar Plates Vacuum-Sealed in Nylon/Polyethylene Packaging Flushed with Nitrogen
Young W. Choi and James V. Rogers
Battelle’s Biomedical Research Center, Columbus, USA

Received: October 23, 2015 | Published: December 29, 2015

Abstract

In resource-limited nations, enhancing the shelf-life and stability of critical reagents and consumables is desired. This study evaluated the shelf-life of bacteriological plates in vacuum-sealed nylon/polyethylene packaging flushed with nitrogen (FlatPacks®). Tryptic soy agar (TSA) FlatPacks held at room temperature for 24 months did not change in appearance or texture and supported bacterial growth similar to Day 0 concentrations. In contrast, TSA plates from a different supplier (Vendor A) desiccated after 4 months of storage at room temperature. TSA, blood agar (BA), and chocolate agar (CA) FlatPacks subjected to desert-like storage and transport temperatures (60 °C) for 30 days supported bacterial growth similar to FlatPacks held at room temperature or refrigerated; TSA, BA, and CA plates (Vendor A) desiccated within 7 days. The data suggest FlatPacks extend the shelf-life of TSA stored at room temperature when compared to traditional packaging. Additionally, TSA, BA, and CA FlatPacks support bacterial growth for at least 30 days when stored at 60 °C. Based on the results of this study, the FlatPacks may help laboratories in resource-limited nations overcome infrastructure, refrigeration, and supply-chain deficiencies. 


Preliminary Evaluation of Mycobacterium tuberculosis Detection in Culture and Artificial Sputum Using a BioNanoPore Membrane and Realtime PCR
James V. Rogers and Young W. Choi
Battelle, Biomedical Research Center, 505 King Ave, JM-7, Columbus, OH 43201, USA 

Received October 26, 2012; Accepted November 20, 2012

Abstract

The rapid detection and diagnosis of Mycobacterium tuberculosis is critical to evaluate disease severity, efficacy of treatments and therapeutics, and public health monitoring. This study evaluated a BioNanoPore technology (BNP™ Middlebrook agar) to detect and quantitate M. tuberculosis in less time than traditional plate counting methods. BNP™ Middlebrook enabled visual detection of M. tuberculosis from actively-growing cultures and inoculated artificial sputum within 5 days; however, colonies were not visible on Middlebrook 7H10 agar. For cultures incubated in the presence or absence of artificial sputum for 19 days on BNP™ Middlebrook, M. tuberculosis ranged from 5.81-5.86 log10CFU/mL from liquid culture and 6.39-6.50 log10CFU/mL in artificial sputum; counts for M. tuberculosis in liquid culture ranged from 5.70-5.85 log10CFU/mL on Middlebrook 7H10. All colonies from 19 day-old cultures evaluated from the BNP™ Middlebrook and Middlebrook 7H10 media were positive for the Mycobacterium insertion sequence (IS) 6110 by real-time PCR. This study demonstrates that BNP™ Middlebrook can detect M. tuberculosis faster than standard plating techniques in the presence or absence of a simulated biological matrix (artificial sputum). Moreover, the BNP™ Middlebrook color development step does not interfere with real-time PCR detection of IS 6110. This study provides a preliminary assessment of the potential use of BNP™ Middlebrook for a more rapid screening and detection of viable M. tuberculosis with respect to clinical specimen evaluation, therapeutic treatment/vaccine efficacy, or epidemiological surveillance.


Decreased time for detection and quantification of virulent Bacillus anthracis and Yersinia pestis using a BioNanoPore (BNP™) membrane technology
James V. Rogers
Battelle Memorial Institute, Biomedical Research Center, 505 King Avenue, JM-7, Columbus, OH 43201, USA

Received 1 December 2008, Revised 2 February 2009 and Accepted 7 February 2009

Abstract

Many aspects of biodefense research require quantitative growth assessments of the test agent. This study evaluated the BioNanoPore (BNP™) technology to quantitate Bacillus anthracis and Yersinia pestis faster than traditional plate counting methods. The BNP™ technology enabled quantification of B. anthracis and Y. pestis in phosphate-buffered saline and naïve rabbit blood at 6 and 24 h, respectively. After 6 h of growth, counts for B. anthracis ranged from 6·19–6·45 log10 CFU ml−1 on BNP™, while counts after 24 h on tryptic soy agar (TSA) ranged from 6·51–6·58 log10 CFU ml−1. For Y. pestis, counts on BNP™ at 24 h ranged from 6·31–6·41 log10 CFU ml−1 on BNP™ and ranged from 6·44–6·89 log10 CFU ml−1 on TSA at 48 h. This study demonstrates that the BNP™ technology provides a more rapid detection of B. anthracis and Y. pestis, which could aid in the evaluation of potential medical countermeasures and treatments as well as other biological defense applications such as surface sampling or decontamination efficacy.


Patents

A partial list of Infectech's (now NanoLogix) patents:

http://nanologix.com/downloads/resources_patents.pdf


United States patents that are assigned to NanoLogix:

Production of hydrogen gas and isolation of hydrogen producing microorganisms using replenishing coated substrates - Patent 7,473,552

Method and device for rapid detection of microorganisms by changing the shape of micro-colonies - Patent 7,524,623

Micromethod and device for rapid detection, enumeration and identification of entities - Patent 7,781,159

Method and device for rapid detection of microorganisms by changing the shape of micro-colonies in micro-channels - Patent 8,067,154

Micromethod and device for the rapid detection, enumeration and identification of microorganisms - Patent 8,361,783

Apparatus for making a solid nutrient medium and associated method - Patent 8,420,384

Device for rapid detection and identification of single microorganisms without preliminary growth - Patent 8,663,909


United States patents that are licensed to NanoLogix:

Flat Packaging of Petri Dishes for Prolonged Preservation and Method of Producing the Same - Patent 8,413,900

Rapid enzyme-linked immunosorbent assay for detection and identification of pathogens and determination of antimicrobial susceptibility - Patent 9,034,583

Methods and devices for rapid detection and identification of live microorganisms by aptamers and/or antibodies immobilized on permeable membranes - Patent 9,068,216


Share Structure

Outstanding Shares: 158,790,445 (as of Sept. 26, 2018). (Previously the company had 145,814,222 shares outstanding on Aug. 8, 2017, and 139,531,530 on Dec. 31, 2014.)

Restricted shares: 47,461,082 total restricted common shares (as of Sept. 26, 2018). (Previously the company had a total of 34,484,859 restricted common shares on Aug. 8, 2017.)

Authorized Shares: 200,000,000 (as of Sept. 26, 2018).


Press Releases and Company Updates

http://nanologix.com/news/press_releases.html

http://nanologix.com/news/updates.html


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Contacts

NanoLogix Inc.
843 North Main Street
Hubbard, OH 44425 USA
330-534-0800 (main line)
330-534-0826 (fax)
info@nanologix.com

Pacific Stock Transfer
6725 Via Austi Parkway
Suite 300
Las Vegas, NV 89119
800-785-7782
info@pacificstocktransfer.com