BioHealth Innovation: Local Startup Developing Technology for Real-Time Detection of Bacteria


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BHI Q&A with 3i Diagnostics, Inc. President & CEO, Jim Janicki & Chief Technology Officer, Rajesh Krishnamurthy

Company: 3i Diagnostics, Inc. “3iDx”

Location: Germantown Innovation Center/Launch Labs

Founded: 2013

Overview: 3iDx is an early stage company developing a new technology platform that is able to isolate and analyze microbes directly from samples for the purpose of identifying antimicrobial resistant strains in less than an hour without having to wait for up to a week for blood culture results. Their ultimate aim is to create a 15-minute test that runs in a battery powered handheld device.

Goal: Our goal is to enable true precision medicine for infection. We see this as the largest single global healthcare issue today, as measured in lives and dollars.

Pipeline: We have developed a new technology platform and it provides new information, never before available, to researchers as well as clinicians. We are building a pipeline of assays for this new platform and our first one is for direct testing of whole blood. Our next assay will be for sputum and then urine, swabs, microbiome, etc. We expect assays will be built for this new platform for years to come and we are working with partners who also want to build their own assays on our platform.

Funding: Our funding has mostly been from angel investors and one venture capital firm. We are currently working toward closing a funding round that will enable us to accelerate development.

• Please share the backstory of 3iDx. From the original idea to bootstrapping to today.

Jim - Rajesh deserves all the credit for the original idea, the technology, and the original funding about 4 years ago. He started by wanting to address the antimicrobial resistance crisis which he saw as out of control with no adequate solutions being launched. He started by studying the problem without a bias toward any specific technology, which I think is a rare approach. Most people have a technology they discover and then start looking around for a problem that it might solve. Rajesh went about inventing the technology that not only addressed the problem but created an elegant solution that was easy to use and could be adopted quickly and affordably. There are many cases where the standard of care has been increased by spending a lot more money on large machines or complex procedures, but I think Rajesh has really achieved something extraordinary because 3iDx has the potential to improve the standard of care so significantly and yet it could actually cost less than what is currently spent on this type of testing today.

Rajesh - My background is in the biopharma industry bringing promising drug candidates to the market. There have been several that have made it to the late stages of clinical trials with a couple of commercially successful candidates as well. One of the main elements that motivates most in the pharma/biopharma sector is the opportunity to have an impact on people’s lives. After more than a decade and a half, I started to wonder how I could contribute besides making drugs. This reflection and research led to the recognition that the biggest clinical challenge for many involved bacterial infections. We had drugs that could treat people but we did not have the ability to know which drug to administer. That is, the physician did not have any timely information to complement their clinical intuition, skills, and experience in determining if (i) an infection was caused by a bacteria or a virus, (ii) if it was bacteria knowing which antibiotic would be most effective, and (iii) to have this information in less than an hour. The absence of this information has contributed to the over-use of antibiotics and necessitated the use of “empirical therapy” when it comes to treating infections. 3iDx was started with the goal of introducing a means to provide this information to the physician thereby positively influencing patient outcomes, treatment costs, and reducing the spread of antibiotic resistance.

• What attracted you to the Germantown Innovation Center and Launch Labs?

Jim - The location is great because it’s near the talent that we need. The terms were surprisingly flexible and they allowed us to keep our costs variable to a large degree, which was important while we were raising investment and developing our first product. It allowed us to move development forward in a BSL-2 lab at a very affordable rate, so we could get data and results that would increase the valuation of our company before the time came for a priced funding round. In addition, the location is very scalable because there are larger life science facilities nearby that we can grow into when the time comes for us to expand. It’s much harder to raise capital for early stage companies since 2008 and moving into this lab allows us to develop our technology to a stage where we can more easily attract early stage funding.

Rajesh - Both the GIC and LaunchLabs offered a means to further our development at reasonable cost. At the GIC, their virtual incubator program provides access to several services (e.g. mailbox, meeting rooms, informative meetings with fellow entrepreneurs, etc.) at a good cost. Launch Labs offers access to lab space that is in keeping with the size of the company permitting us to gather data again at a reasonable cost. When one is bootstrapping and trying to stretch every dollar to its maximum, such programs are very helpful. Both are also located in close proximity to our collaborators providing an additional advantage.

• How do you feel about the present startup environment for life sciences companies in Maryland?

Jim - I think Maryland has a chance to really seize a huge opportunity if we are willing to think a little bigger and make a few changes. The start-up environment is ok, but it could be great. The life science start-up environment across the country is in a rut. There is a bolus of extreme early stage technology because of capital constraints created since 2008 resulting in little money being invested in the seed stage of companies. This has created a funding gap that technologies cannot bridge in order to launch commercially, hence we have lost a decade of life- science innovation in the US. I even know people who have left the life- science industry because of the lack of funding and loss of jobs. Meanwhile, traditional life-science innovation locations have skyrocketing costs of living. If Maryland were to: 1. Create more facilities that are flexible and affordable 2. Co-locate funding, innovative people, and affordable facilities 3. Foster a creative environment with a culture that encourages breakthrough innovation 4. Upgrade some key state laws, then I think Maryland could be a major destination for life science innovators who are searching for an affordable and attractive location for their future.

Unfortunately, there are some laws in Maryland that hinder small companies and start-ups "e.g., small business access to health insurance through PEOs". I’m sure these laws had some intended benefit when they were created, but I see them as something that repels entrepreneurs who might otherwise relocate to Maryland. In fact, they forced me to explore if we should re-locate outside of Maryland, and that’s not the conversation you want your entrepreneurs to start having. We should be aware that other locations (i.e. Scotland and Canada) offer major benefits for start-ups by doing things like paying 50% of the cost of R&D employees as well as supplementing facility costs. We need to look at the whole picture, but at a time when people are looking to migrate to more affordable living, why not make Maryland the most attractive place in the world for them to bring their start-up? This is a unique time of migration for these people and once they settle somewhere, they will be less motivated to move again.

Rajesh - I think that the present startup environment is okay but not great; though the state has done a lot to foster the growth of the biotech industry. In my opinion, there is a lot of support structure in this region (once one knows how and where to look for it) like MCCED, BioMaryland, and BHI. But I feel that the area is capital-limited. There is a wealth of technical talent, a small pool of biotech entrepreneurs who have taken companies from nascency to success, and an even smaller pool of investors who are able to seize on the opportunities, evaluate risks, and contribute to a start-up’s growth. However, I feel that we are one or two real big successes away from initiating a virtuous cycle attracting more investors and entrepreneurs to the area. I hope that 3iDx will be one of these successes!

• Where do you see your new technology having the biggest impact?

Jim - I think the biggest immediate impact will be when we rapidly identify microbial strains that cause blood infections for sepsis patients. Patients who present with sepsis could have over an 80% chance of surviving this medical emergency if they can get the correct targeted antimicrobial drug within the first hour. This almost never happens since all technologies today require blood culture before the tests can be run and blood culture takes between 2 and 6 days, which is why we see survival rates like 30% for these patients in the US. Broad spectrum antibiotics are not the silver bullet they once were due to the antimicrobial resistance crisis. People have been contacting me with stories about how family members died or suffered from infections because it took too long to identify the pathogen. Resistant strains and superbugs are now so common that we need to know what the microbe is before we can properly treat it. I think it’s agony for patients and physicians to check the blood culture every day, sometimes checking for 6 days in a row, before finding out what they are dealing with. The stories people tell me are so tragic at times that I have to sit down and take a break after talking to them. Blood culturing is a 150 year old technology and it’s time to find a better way for identifying microbes, and that’s why Rajesh abandoned any thought of using blood culture when he started working on our technology. We are losing the battle against antimicrobial resistance in a big way and it’s mostly because of a failure of imagination.

• What were the main challenges you faced when starting 3iDx?

Jim - I think our biggest challenge was the technology was so new and different that people had a hard time wrapping their head around it. We are launching a technology that identifies the unique molecular structure of a whole microbe, which better represents the behavior of an organism as compared to other molecular techniques. I am personally a huge fan of the genetic revolution and I think a lot of people really want us to just use another DNA assay or a genetic marker since it’s their comfort zone, but we ran into too many limitations exploring that path and we are laser focused on creating clinical utility and not just doing what is easy or convenient to develop. We want what is easy, effective, and affordable to implement.

The immediate benefit wilI come from physicians being able to prescribe the correct targeted antimicrobial for infections within an hour instead of up to 6 days. In addition, our technology will enable new antibiotics to be developed faster and at lower cost because patients can join those clinical trials before they are already treated with other antimicrobials that can confound the statistical data in the clinical trials, which is what makes them long and expensive. I also believe we need to get this technology into research labs. This is truly new information for researchers and can be used in addition to genetic information to accelerate discovery. I’m convinced that we will see scientists discover completely new approaches to fighting resistant strains when they can study how these organisms adapt at the whole-body level without killing the organism they are studying. Our technology is non-destructive so we are able to retain and grow the microbes after we create the molecular fingerprint that identifies them. Give a curious scientist something never before measured and something wonderful will happen.

• What makes 3iDx different from other device companies in the same market space?

Jim - The biggest difference is we don’t require blood culture and we don’t require the lab to guess what they are testing for. Other companies have assays that are made up of small panels and the lab has to keep guessing which panel to test for and they keep buying new panels until they get a positive result. Our database of molecular fingerprints will grow quite large and we expect to provide useful information every time a lab runs our test. Our test will let the lab know if a microbe is present, which is useful for antibiotic stewardship. Meaning, if a microbe is present then it will be rapidly and accurately identified so it can be treated precisely while the patient is still in the waiting room. And in the end the microbes are contained and protected in our cartridge and they are alive and viable so they can be transported to support the current trend of centralization of microbiology labs. The microbes can be grown in culture at a later time without having to take more blood from the patient. This enables longer term confirmatory testing and sample retention for pathogens that need further study.

• What specific advice would you offer to a first-time entrepreneur?

Jim - I think they should constantly invite advice. They should be voracious life-long learners; and they should always remain curious and on the lookout for finding a better way for each challenge or opportunity they encounter or create. Also, I think they should be careful about which advice they choose to implement. Almost all the advice they get will come from someone who knows less than they do about their own business and technology. It’s like the person giving advice is looking through a pin hole when they see your business and even if they are giving you genuinely good advice, it is probably based on limited information and it may therefore not be the best advice to implement without giving it some critical thought first. There are many ways to succeed just like there are many ways to fail. Don’t be so enamored by someone who you admire for being wildly successful such that you just execute their advice because you think it will bring you the same success. The world is a lot more dynamic and a lot more interesting than that. You need to find your own way while actively seeking to improve yourself along the way.

Rajesh - That is difficult to say since every entrepreneur’s circumstances is different. For me, the biggest lesson so far has been the value of persistence. The popular media had me believing that the strength of the idea, data, and market opportunity were all it would take to secure sufficient investment for product development. These elements are absolutely needed but timing (i.e. state of economy and investors), luck, and several other non-objective elements also play a big role. For these elements to align we have needed to exercise a lot of patience and resilience. This appears to be paying off as our collaborations continue to expand and our progress toward a working alpha unit is accelerating. We look forward to more investment that enables us to further accelerate development toward our commercial launch.