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3i Diagnostics, Inc. |
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May 7, 2018 Issue |
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CEOCFO MAGAZINE |
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Q&A with James Janicki, President and CEO of 3i Diagnostics, Inc. developing a new Diagnostic Platform capable of Isolating Microbes, Bacteria and Fungi from a Blood Sample in Less than an Hour to Identify “Super Bugs” that lead to Drug Resistant Infections |
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President and Chief Executive Officer
3i Diagnostics, Inc.
Interview conducted by: Lynn Fosse, Senior Editor, CEOCFO Magazine, Published – May 7, 2018
CEOCFO: Mr. Janicki, would you tell us the idea behind 3i Diagnostics? Mr. Janicki: We started by studying the problem prior to developing any technology for the solution. The idea behind the company came from looking closely at the actions needed to address the antimicrobial resistance crisis caused by drug resistant infections, also referred to as “super bugs.” We wanted to understand why the crisis was continuing out of control. Why weren’t patients with these infections being isolated sooner? Why were clinical trials so long and expensive for new antibiotics? Why were more of these infections progressing to deadly conditions like sepsis? Why were most antibiotics still given to people who don’t have the bacterial infections that the antibiotics treat? Our conclusion was that these infections needed to be identified in less than an hour with an easy to use affordable method that was also suited to eventually be a portable point of care test. Existing tests for identifying all of these infections took 2 to 6 days, and had to be run in a microbiology lab so physicians were routinely implementing treatment without knowing the identification. They didn’t have time to wait days for the results. So, we focused on developing a solution that would be affordable, easy to use, and identify the organism in less than an hour.
CEOCFO: What have you figured out? Mr. Janicki: We looked at the field of other potential solutions being developed and we found that the technologies being pursued looked unlikely to ever be able to return a result in less than an hour at an affordable cost while being accessible at the point of care. We noticed what looked like a herd mentality that assumed the answer had to be a DNA focused technology, which we felt blinded many to other possibilities. We realized that even if development was optimistic for those technologies, they would fall short of what was truly needed. Our advantage was to thoroughly suspend our preconceived biases so that our thoughts were free to develop a genuinely new approach to the solution.
CEOCFO: You received Breakthrough Device designation from the FDA. What is the solution? Mr. Janicki: Our solution is called BiospectrixTM and it’s a new diagnostic platform that removes all the components of a blood sample but isolates the bacteria that needs identification. This removes all the noise and interference that the blood components of the sample would cause when identifying the bacteria. We then scan the bacteria with a proprietary infrared scanner that characterizes the unique molecular structure of that organism. We are then able to identify the organism by looking up the scanning pattern in a database. Our current results suggest we will be able to identify many drug resistant versions of bacteria.
CEOCFO: How does Biospectrix™ get rid of the blood and isolate whatever else is in there? Mr. Janicki: Finding and isolating the few bacteria in a blood sample is a lot like finding a needle in a haystack. Other technologies that we saw being pursued relied on very sophisticated and expensive ways to essentially reach in and try to grab the “needle” (bacteria) and pull it out of the haystack (blood). We were able to take the opposite approach and essentially burn down the haystack and then sift the “ash” to isolate the needle quickly. This invention came from the mind of our Chief Technology Officer, Rajesh Krishnamurthy.
CEOCFO: How do you “burn down a haystack”; what are you doing? Mr. Janicki: We created something that had never been done before. We call it the Selective Lysis Chamber. The selective lysis chamber takes advantage of the difference in strength between bacteria and blood cell walls. We are able to uniformly modulate the forces in the Selective License Chamber, so that all of the blood cells are broken down into very small pieces and yet the bacteria are unharmed and intact. After identifying the bacteria, we are still able to grow the bacteria for further characterization and study without having to get another blood sample from the patient, which is an additional advantage of our approach. This fits very well into the existing work flow of clinical labs as well as research labs.
CEOCFO: Are there some types of bacteria you are able to find more easily? Mr. Janicki: We are focusing on bacteria first and we also expect this to work well for fungi. We may eventually work on applying this to viral infections but we are focused on bacteria first. We believe that it will also work on parasites like malaria.
CEOCFO: What is the process if someone wants to use this test? Mr. Janicki: We are building a single-use disposable cartridge. It starts with a standard blood sample from the patient. We inject that into our disposable cartridge and in less than an hour the bacteria is isolated from the blood and scanned for identification. The identification scan is done through a window that is in the cartridge so you do not have to open the cartridge and risk contamination of the bacteria or risk exposing others to the bacteria. We envision later generations of BiospectrixTM being a point of care test that can be used anywhere and not just in clinical labs. We are planning a global cloud-based system where these test results are uploaded to the cloud in real time so that we can create a real time “weather map” of drug resistant strains around the world that can be monitored at all times. We see this as a key tool for monitoring outbreaks and tracking drug resistant strains. We would like to see places like hospitals be able to set a 50-mile perimeter alert around their hospital to monitor when new drug resistant strains show up near them so they can prepare for how to handle these “super bugs” before they show up in the hospital facilities.
CEOCFO: What is the plan now that you have FDA Breakthrough designation? Mr. Janicki: According to the FDA web site, Breakthrough designation is for devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; for which no approved or cleared alternatives exist; the availability of which is in the best interest of patients; and that offer significant advantages over existing approved or cleared alternatives. I feel this is consistent with our vision and goals for BiospectrixTM and we appreciate this designation very much.
CEOCFO: What will you do in terms of testing for the next year? Mr. Janicki: We are now in the process of raising an investment round and we are going to accelerate development as soon as we close the funding round. We are currently using prototypes in our lab and we expect it will be about 24 months before have the first fully integrated instrument built. We plan to continue to test samples from our suppliers and collaborators to build our database of bacteria identification signatures. We plan to design the first clinical trial around a manageable number of organisms in order to achieve approval of our device as quickly and efficiently as possible. We will then expand the approved signatures in the database with additional trials over time.
CEOCFO: What has been the interest from the investment community? Mr. Janicki: We are getting a lot of interest especially since the FDA Breakthrough Device designation came out and I anticipate that we will close this funding round before the end of the year. People recognize that we are going after a major need that is now a global crisis, and from an investor’s perspective it is a major opportunity. We look at the healthcare budgets of hospitals and some payors and see that 40% of their expenses go toward managing and dealing with infection. One of the areas that is a significant market segment for us are patients who come down with sepsis that is caused by an infection. Sepsis is a very serious emergency and there are papers suggesting that if you can get the right targeted antibiotic to that patient in less than an hour you might be able to increase their probability of surviving the condition from about 30% to over 80%. Tests today can take two to six days to characterize one of these drug resistant bacteria but the physicians and patients need to know within the first hour what infection they are dealing with, and the physician needs to know what type of strain it is so they can treat it optimally right away. I think the investor interest tends to focus on the value this will provide for the segment of our market made up of sepsis patients because it is probably the most urgent need for specific infection identification, but the overall market size is much larger than just this segment. We believe BiospectrixTM has the potential to create a new market that may be on the order of $20 billion while also taking share from the existing $12+ billion infectious disease testing market.
CEOCFO: You have had lots of experience in the medical industry on many levels. What have you learned from past experience on what to do and what not to do in bringing a product to market? Mr. Janicki: I have experience leading global diagnostic businesses, and this has shown me just how important it is to focus on the problem-solving process that a physician goes through which is incredibly complex. I look closely at how I can provide clinical utility, which I define as delivering relevant information that is affordable, easy to understand, and fast enough to significantly aid physicians in making treatment decisions that improve patient outcomes. Many people develop cool technologies and many of them come out of respected institutions and have impressive publications and they get significant funding, but I think too many of them look like cool science experiments that are developed without being focused on all the characteristics that create a great product that delvers both clinical utility and economic benefit at the same time. In addition, I look at how to design a product that has a good value proposition for each layer in the healthcare stack. The product needs to have good answers to the following questions. What is the value proposition for the patient? What is it for the physician and what about the hospital or institution that physician works in, and what about the payers? What is the value proposition for each of them as well as some of the organizations that own multiple hospitals. We actually tested all these value propositions for BiospectrixTM before deciding that it fits well into the whole healthcare stack.
CEOCFO: Why pay attention right now to 3i Diagnostics, and what might be overlooked at first glance? Mr. Janicki: I think that 3i Diagnostics is positioned to launch a genuine new platform technology and that’s a much larger opportunity than just blood testing. We have been talking a lot here about testing blood for bacteria and microbes but it turns out that there are many different applications this will go into for many different types of samples. We are working with an institution now where we are testing tuberculosis, which is going to be a sputum sample instead of blood. We expect to see future tests for biomedical countermeasures, veterinary, food, water, surface contamination, and more. But, for now, we are being careful to stay focused on blood testing and successfully launching the first BiospectrixTM platform. |
“Our advantage was to thoroughly suspend our preconceived biases so that our thoughts were free to develop a genuinely new approach to the solution.”- James Janicki
3i Diagnostics, Inc.
Contact: James Janicki 301-515-6380
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Microbe Identification, 3i Diagnostics, Inc., James Janicki, Developing a new Diagnostic Platform capable of Isolating Microbes, Bacteria and Fungi from a Blood Sample in Less than an Hour to Identify “Super Bugs” that lead to Drug Resistant Infections, CEO Interviews 2018, Medical Diagnostics Companies, Identify harmful microbes, identify beneficial and harmful microorganisms, microbial identification, test for microbes, 3i Diagnostics, Inc. Press Releases, News |
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James
Janicki