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It’s a New Frontier of Medicine: Galaxy Diagnostics Goes Beyond the Limits of Detection to Drive Discoveries in Chronic Infectious Disease Reveals Amanda Elem

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Amanda Elem Galaxy Diagnostics

First of all, how are you and your family doing in these COVID-19 times? 

Amanda Elem: We are doing well. I have three grown children, two in college, and one is out working. In the spring, we had a full house with two students finishing their semester from home along while my husband and I are working remotely. Everyone is healthy.

Tell us about you, your career, how you founded Galaxy Diagnostics

Amanda Elem: I am both an entrepreneur and a scholar. I hold a Ph.D. in Sociology (UNC-Chapel Hill) with a research focus on entrepreneurship and innovation. In addition to my role as CEO/Co-founder of Galaxy Diagnostics, I hold an appointment as a Diana Research Fellow at Babson College in Massachusetts. I caught the innovation and entrepreneurship bug working for a software startup right out of college. After several years, I returned to grad school to study business startup and innovation systems. I finished my doctorate and two postdoctoral fellowships in 2008. Not great timing for an academic job search! So I ended up teaching part-time at NCSU and joining a startup. 

I co-founded my company, Galaxy Diagnostics, over ten years ago with two scientists from NC State University. My cofounders Dr. Ed Breitschwerdt and Dr. Ricardo Maggi, are global experts in flea and tick-borne disease. They developed a patented sample enrichment method to increase the sensitivity of DNA detection for a bacteria that few people have heard of called Bartonella. We launched the company to commercialize this advanced sample enrichment direct detection method for animal health and human health markets with the hope of quickly advancing research discovery around the importance of this recently discovered bacteria. The emerging research implicates Bartonella in a range of chronic diseases affecting the heart, joints, and nervous system, including several cancers. It’s an exciting area of medical discovery!

How does Galaxy Diagnostics innovate? 

Amanda Elem: Our company is developing and commercializing diagnostic advances that go beyond the limits of detection to support earlier diagnosis of hard-to-detect flea and tick-borne infections linked to chronic illness, like Bartonella (cat scratch disease) and Borrelia (Lyme disease). Our focus is on innovative sample enrichment techniques that support direct detection of active infections in patient samples. We have enjoyed success at driving research discoveries with our sample enrichment approach to molecular confirmation. We are now combining those sample enrichment techniques with new technologies that go even further beyond the limits of conventional lab tests for hard-to-detect infections.

How the coronavirus pandemic affects your business, and how are you coping?

Amanda Elem: It was a wild ride and tough on our whole team. Like many medical laboratories focused on testing in chronically ill populations, the pandemic resulted in a severe business interruption in April. As a medical lab, we qualified as important business, so we continued operations with additional cleaning protocols and workplace safety requirements. Our market has slowly recovered as patients make their way back into the doctor’s office. At this point, we are well into recovery and focused on our growth plan.

In addition to steering my company through the pandemic crisis, I was also in emergency mode at Babson College, conducting research on pandemic impacts on women entrepreneurs around the world.

You can see our findings here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7426720/ and here: https://www.babson.edu/academics/centers-and-institutes/center-for-womens-entrepreneurial-leadership/diana-international-research-institute/research/

Did you have to make difficult choices, and what are the lessons learned?

Amanda Elem: Our most difficult choice was whether to direct our lab expertise and resources to COVID-19 or stay the course and focus on our core business. In the end, we decided to stick with our current business and leave the rapid COVID-19 testing services to the big labs. The lesson learned is that, while small companies are often thought to be more nimble than large companies, in a crisis that directly impacts sales revenue, it is actually easier and makes more sense for large research institutions and large commercial labs to organize emergency response.

How do you deal with stress and anxiety, how do you project yourself and Galaxy Diagnostics in the future?

Amanda Elem: Funny, you should ask. As CEO, I saw it as my job to remain calm and navigate with my team effectively through the crisis. That went pretty well, but only with help from regular exercise, healthy eating, and lots of sleep. I actually started doing Noom (a health and diet app), which provided some great structure to my day and held me accountable as I logged exercise, meals, and other good habits each day. I actually lost 10 lbs! Aside from those healthy habits, it helped me keep in close touch with family and friends through video and text messaging.

At work, I increased communications with my entire team that kept them up to date every step of the way on our financial outlook, applications for business relief, and information from my network in infectious disease and public health on the pandemic outlook and best guidance. Everyone pulled together and did very well. We did not lose anyone and, I believe, have emerged stronger as a team and a company.

At this point, we are back on our original growth plan and forging ahead with new tests launching this year and next. We are optimistic as we head into 2021 and are looking forward to important advances in our research in addition to the expansion of our test offerings. The challenge now for our small company is to get research funding behind some much needed clinical studies to clarify the importance of Bartonella and potentially other flea and tick-borne infections for serious diseases, like heart infections, seizures, arthritis, and cancer. 

Who are your competitors? And how do you plan to stay in the game?

Amanda Elem: We have several competitors, including all the big labs offering conventional testing for flea and tick-borne diseases and several niche players. Also, many doctors prefer not to test and will instead provide a strictly clinical diagnosis. Lab medicine is a heavily regulated and heavily contracted marketplace with severe downward price pressures. The big labs are like Walmart, and the insurance companies prefer Walmart’s pricing. So small labs can struggle to survive in the healthcare marketplace, even when they offer more sensitive, clinically useful testing based on high-quality peer-reviewed published research.

We have built a very strong scientific brand in our niche based on our deep expertise in emerging infectious disease and a strong publication record. Our goal is to build the market for Bartonella testing and introduce game-changing diagnostic advances for direct detection of a range of low yield infections. We believe that if we create high-quality, affordable offerings based on sound published science, we will eventually win the market. We are very active in medical education and work closely with patient advocates to build awareness about our disease area.

Your final thoughts?

Amanda Elem: We are truly on a new frontier of medicine: the infectious causation of chronic disease. COVID19 has offered the world a crash course in emerging infectious disease with a clear introduction to the limits of different types of infectious disease testing and the puzzle that is asymptomatic/pre-symptomatic infection, limited rates of acute disease, and persistent, chronic symptoms. Medicine is wrestling with the same puzzle but for slow-growing, hard-to-detect pathogens than stay under that radar until stress, trauma, or age trigger symptoms. Too often, these symptoms are misdiagnosed as an autoimmune disease and, in the worst cases, result in heart failure or cancer. This is our problem set, and it is a very lonely, highly contentious, and underfunded area of medicine. But that, my friend, is one of the costs of true innovation. 

Your website?

http://www.galaxydx.com/

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