by After a very busy year at Galaxy Diagnostics, we have some exciting news to share. As of June 17, 2024, Nicole Bell has officially accepted the position of CEO and Jeff Clark has joined Galaxy Diagnostics as Chair of the Board.
With over 20 years of experience in commercializing innovative technologies, Nicole Bell brings an incredible wealth of experience in building R&D programs, driving products through to FDA approval, and exceptional executive leadership. After losing her husband to a devastating illness that involved flea- and tick-borne illness, Nicole set out to use her engineering skills and experience to ensure that no family would have to go through a similar experience.
Jeff Clark is a serial entrepreneur and venture capitalist based in Research Triangle Park, North Carolina. Throughout his career as an entrepreneur and investor, Jeff has demonstrated an enduring passion for empowering visionary founders to make a difference in patient care and healthcare delivery.
Founders Remain Committed
We thank Dr. Elam for her long years of service as CEO and Dr. Breitschwerdt for his unflagging service and commitment to Galaxy as Board Chair. Drs. Elam and Breitschwerdt will continue to serve as Board Directors and key advisors to support the commercialization strategy, expansion and growth of the Company. Our scientific leadership team remains in its current structure, with Dr. Breitschwerdt as Chief Science Officer, Dr. Richardo Maggi as Chief Technical Officer and Dr. Robert Mozayeni as Medical Director.
Galaxy’s leadership as a One Health company in the flea- and tick-borne disease market has established a firm foundation for a new standard of diagnostic care in this important area of emerging infectious diseases. The founders remain committed to the Galaxy mission (better patient outcomes!) and look forward to launching the Company into its next stage of growth.
Progress to Date
Thanks to the founders’ vision and commitment to excellence, Galaxy Diagnostics has established a strong foundation for long-term growth and positive impact on patient care in the field of emerging infectious disease. Following the spin-out of the company from the North Carolina State University College of Veterinary Medicine in 2009 with a single test for a single pathogen in dogs (the novel Bartonella ePCR™ test), the company was awarded the first non-HIV grant (for bartonellosis) under the NIH/NIAID SBIR program, establishedof a CLIA-accredited laboratory, and launched clinically validated lab-developed test offerings for medical providers in human health.
In addition to funding early growth through test revenue, Dr. Elam brought in over $1 million in research funding from government and private foundations and seed-stage funding in 2014 to support the development of a pipeline of novel diagnostic tests, the successful expansion of clinical test offerings for human health, and the advance of medical education through key advocacy partnerships. Concurrently, Drs. Breitschwerdt and Maggi grew the Intracellular Pathogens Research program at NCSU-CVM with over $5 million dollars in support from the Steven & Alexandra Cohen Foundation, the American Kennel Club, and other private donors and corporate sponsors.
Most recently, Dr. Elam led the company successfully through the COVID-19 pandemic, including the validation and launch of the second-generation Bartonella Digital ePCR™ assay (supported by SBIR funding from NIH/NHLB) and the Lyme Nanotrap® Urine Antigen Test (supported by the Cook Foundation and in collaboration with Ceres Nanosciences and George Mason University). Importantly, Dr. Elam has also positioned Galaxy’s novel diagnostic solutions well for clinical accessibility and affordability by ensuring the publication of evidence supporting clinical utility and acquiring reimbursement codes.
Finally, Dr. Elam has brought the same energy to her service in the vector-borne disease community as a whole, including contributions to the federal Tick-borne Disease Working Group, Lyme X Diagnostics Award program, and the Coalition for Innovative Lab Testing. Her insights and contributions highlight the challenges and opportunities for commercializing diagnostic innovations in the evolving landscape of clinical laboratory services and the emerging market for vector-borne disease.
Next Steps for Galaxy
With this exciting news, we look forward to bringing important direct detection solutions to meet the urgent unmet clinical need in the flea- and tick-borne diagnostic market. Direct detection is critical to establish a new standard of care for patients affected by these infections. Emerging research implicates a number of different vector-borne infections in chronic illnesses affecting multiple body systems, including the joints, heart, and brain.
Our diagnostic advances have played an important role in identifying potential disease associations for Bartonella spp infection (e.g., cat scratch disease). As we expand our research program and clinical services, we expect that our direct detection solutions will lead to a better understanding of the clinical importance of these infections for human and animal health.
Building on the solid foundation of technology and a customer base that appreciates diagnostic quality and exceptional customer service, our ultimate goal is to make FDA-approved IVD kits to power clinical testing for vector-borne diseases at labs around the world. The first step toward this goal is to expand our techniques to support the detection of other vector-borne pathogens implicated in complex chronic illnesses.
We will offer these innovative solutions as lab-developed tests to support early access and to allow us to work closely with our customers to inform development and clinical practice. From there, we will work with our industry and academic partners to advance the technologies into mainstream laboratory use.
We are very grateful to our customers, employees, advisors, and followers for their continued support. The best is yet to come!
