To slow this tide of antibiotic resistance, NanoLogix has developed a series of rapid, viable microorganism tests that return results in about 4 to 6 hours, compared to 24-72 or more.

ADVANCE spoke with NanoLogix CEO, Bret Barnhizer, about the technology.

ADVANCE: What are the challenges labs face in getting quick results on antibiotic resistance?
Bret Barnhizer: While PCR tests have decreased wait times significantly for both bacterial and viral tests, their high price point and primarily qualitative (yes/no) results often provide less information than other quantitative tests with longer wait times. Unfortunately, qualitative test results, such as those with PCR, can only tell if a bacteria is present--not its viability and threat level. In addition, PCR results do not reveal if the bacteria found is already resistant to antibiotics (known as sensitivity).

Before the new BioNanoPore, BioNanoFilter and Quick Test kits were developed, the long wait times for Petri results (in many cases several days) seemed to be the only alternative. Growing bacteria more rapidly clearly wasn't possible, so NanoLogix researched and developed methods that enabled laboratory staff to see the growth of microcolonies sooner, with a simple micro-pored membrane. In microbial detection, only what is alive is harmful. NanoLogix reveals these live cells sooner, and provides information on antibiotic sensitivity 4-12 times faster.

A: Why is it so important to diagnose antibiotic resistance quickly?
B: Treatment for antibiotic-resistant patients is incredibly expensive. In fact, the Center for Science in the Public Interest estimates the annual cost of treating antibiotic resistance may be as high as $30 billion.

Health-wise, drug-resistant strains of bacteria also pose serious threats to the effective treatment of dangerous pathogens like MRSA, Staph, E. coli, Group B Strep and many others. General and un-targeted use of broad spectrum antibiotics is leading to stronger, more pervasive strains of bacteria resistant to antibiotics known as 'superbugs'--highly resistant strains of bacteria.

Because conventional Petri dish testing methods often delay accurate diagnosis, many physicians are forced to treat patients with broad-spectrum antibiotics until test results can suggest a more precise protocol. These preemptive treatments can help protect against bacterial pathogens, however they also fortify strains of antibiotic-resistant bacteria, making them even more difficult to eradicate. Thus, demands are increasing for faster, less expensive technology to detect and identify bacteria very quickly, complete with antibiotic sensitively.

A: How do the NanoLogix tests improve upon current methods?
B: NanoLogix technology pushes Petri dish testing to a higher level of accuracy and convenience. Similar to the PCR approach, NanoLogix uses nutrient agar in a culture dish to grow bacteria and other microorganisms, such as E. coli, Salmonella spp, Group B Strep and Anthrax.

Instead of waiting 18-24 hours to obtain test sample results, NanoLogix test kits grow microorganisms on a permeable membrane that can be transferred to a staining plate for viewing in a few hours. After just 5-15 minutes on the staining plate, live-cell micro colonies can be detected and examined. Because these micro colonies are not allowed the time to grow larger and overlap, the Nanologix procedure facilitates faster colony count and more rapidly exhibits the density of the sample.

This foundational technology is called the BioNanoPore (BNP) product. After a few additional filtration and washing steps with the BioNanoFilter (BNF) technology, the identification of targeted microorganisms is made possible. In addition, antibiotic resistance of the bacteria can be shown in both the BNP and BNF kits.

It is as simple as adding specific antibiotics to the nutrient agars. If the bacteria continues to grown after the antibiotic is applied to the sample it reveals antibiotic resistance. As an example, if growth of staph aureus is revealed while the BNP or BNF agars have a methicillin-based antibiotic present in the agar, then we have we detected the presence of MRSA.

A: Can you explain how the technology works?
B: Beyond just employing a nutrient agar to culture colonies, Nanologix technology allows a permeable, cellulosic membrane to be placed between two agar layers. The ultra-thin, transparent membrane enables microbial growth, which can then be moved to a staining plate in far less time than conventional incubation methods. Five minutes later, previously invisible micro colonies are able to be detected.

A filtration process (in the BioNanoFilter technology) based on an immuno-enzymological method that uses HRPantibody conjugates removes unwanted microbes. After this filtration step results reveal whether a bacteria being targeted (such as E.coli, Salmoella, MRSA or others) is present in the sample. This target identification process increases sensitivity to as low as one cell in one liter of water. A final step for BNP or BNF reveals if the bacteria found is resistant to antibiotics.

A: How will this benefit patients?
B: NanoLogix technologies hasten detection of bacteria exponentially and affordably. The Nanologix BioNanoPore test kit cuts wait times for detecting bacteria such as Salmonella from 24 hours to approximately 5 hours, and E. coli from 18-24 hours to as soon as 4 hours. This means early, quantitative results, that afford physicians and technicians the ability to make more informed diagnosis and treatments for patients, and be less reliable on broad-spectrum antibiotics as precautionary measures.

Waiting days to receive live-bacteria results can be dangerous, if not life-threatening. When you need to know if a microorganism is present and alive in a sample, time matters. The Nanologix BioNanoPore, BioNanoFilter and Quick Test kits enable physicians and technicians to identify bacteria within a few hours, thus allowing for faster, more targeted treatment and care of patients.

A: How will it benefit lab professionals?
B:Nanologix products give physicians and lab technicians faster, more targeted results, which ultimately gives them the ability to recommend more refined treatment of patients while also decreasing the likelihood of antibiotic resistance. They also have an ability with NanoLogix to conduct tests with in one shift, and minimize testing errors that occur when a test is handed off to a new lab technician during a shift change. In addition, attaining faster results in less time means labs can increase their volumes and revenues. 

For hospital and clinic labs, another plus is the ability to do more tests in house, saving both time and money compared to sending samples to an external lab. This benefit also applies to laboratories on the periphery of health systems in developing and rural regions, where it may be several days drive to the nearest lab.

A: What's in the future for this technology?
B: Researchers see technologies, such as NanoLogix BioNanoPore, BioNanoFilter and Quick Test kits as the "new gold standard" and a "Louis Pasteur moment" in the field of rapid diagnostics. They can be employed to expedite data collection and provide same-day quantitative bacterial detection in myriad industries, from cosmetics and pharmaceuticals, to food/ beverage processors, clinics and veterinarians.

Unlike PCR and traditional Petri dish methods, NanoLogix technology expands the field of health diagnostics, and offers accurate, low-cost solutions to laboratories and several industries.

As word spreads about the third-party validation of NanoLogix technology conducted by the University of Texas Health Science Center-Houston, the adoption of this technology is expected to expand exponentially. Additional tests are in development for the following: 

• "Super" gonorrhea (antibiotic resistant, Neisseria gonorrhoeae)
• The "superbug" E.Coli O104 (discovered in Germany last May)
• Multi-drug resistant tuberculosis

NanoLogix is also exploring the potential application of its technology on viruses.

A: How does this advance laboratory medicine?
B: Advances in technology and testing are taking laboratories in two directions. Some advancements in the field are making labs more specialized, while technologies like NanoLogix are making live-cell bacterial detection easier and less expensive, and therefore more available to the masses. Many labs do not have the budget for specialized equipment or training, so inexpensive tests that accelerate detection times and simplify lab operations are extremely beneficial.

Hospitals and private practice physicians can now perform more of their own lab work without having to send out samples and wait for results. Faster results also permit many more tests to be done during the same shift, thus reducing the margin for error that can occur during a shift change, as well as allowing tests to be completed in a shorter period of time. Finally, NanoLogix tests empower labs in developing and rural regions, protecting populations in these areas from unnecessary health risks.