by 
The holidays are upon us, and we extend the warmest wishes to you and yours for a season of celebration, giving, and reflection. We are excited to share the milestones that have defined our progress this year—including new insurance codes, research publications, and advocacy milestones—that we believe will help advance patient care and offer hope to the many individuals and families fighting for wellness.
New Insurance Reimbursement Codes
It was a lengthy process, but we now have insurance codes for the first set of our ultrasensitive direct detection assays. Insurance reimbursements are an important way to make our tests more affordable and accessible for patients. These are proprietary lab codes (PLA codes) that only Galaxy can use to bill for the tests offered. We started billing private insurance providers and Medicare earlier this year and are excited to see the reimbursements coming through. See our Test Menu for full details.
CPT 0316U Lyme Borrelia Nanotrap® Antigen Test
CPT 0302U Bartonella Digital ePCR™ Single Draw (x3 for Triple Draw)
CPT 0301U Bartonella spp ddPCR
Our long-term goal is to apply these approaches to antigen and DNA detection very broadly to the pathogens transmitted by fleas and ticks and to develop FDA-approved IVD kits to sell to laboratories around the world. The increased sensitivity of the Lyme Borrelia Nanotrap® Urine Antigen test and Bartonella Digital ePCR™ is well documented in the medical literature, supporting both proof of concept for sample enrichment and clinical utility for confirmation of active/current infection.
Key Research Publications
Our research and diagnostic development efforts at Galaxy are powered by research collaborations with Galaxy cofounders at NC State University and researchers at other leading academic institutions and commercial partners. This year saw a number of important new studies published by Galaxy cofounders and NC State researchers:
- One study investigated environmental exposure as a previously unrecognized source of Bartonella infection for animals and human beings.
- Another study explored Bartonella seroreactivity among veterinary workers in the Pacific Northwest, noting the unclear relationship between occupational risk factors, detectable antibodies, and disease expression. The study also revealed no consistent cross-reactivity between Bartonella antibodies and other zoonotic and vector-borne pathogens.
- A published case report showing substantial clinical improvement in a young patient with autism spectrum disorder following treatment for polymicrobial vector-borne infection raised important questions about the role of infection in pediatric neuropsychiatric disease.
- Finally, Dr. Breitschwerdt joined a consortium of researchers on the publication of a consensus protocol addressing the role of brain infection in patients with mild cognitive impairment and Alzheimer’s disease. The Alzheimer’s Pathobiome Initiative will perform comparative molecular analyses of microbes in post-mortem brains and other biological fluids and tissues to provide a roadmap for detecting and more effectively treating infectious agents in patients with mild cognitive impairment or AD.
Advocacy Milestones
This was a big year for tick-borne disease advocacy as well. Our team was involved in one way or another in three major events:
Tick-Borne Disease Working Group 2022 Summary Report
We were excited to see the release of the third and final summary report by the U.S. federal Tick-Borne Disease Working Group in February. For the first time, the TBDWG considered the challenges to commercializing diagnostic and tick bite prevention solutions, in addition to the better-known challenges of access to research funding and support for critical innovations for prevention, diagnosis, and effective therapies. As we build the pipeline of innovations, we need to ensure that there is adequate published clinical utility data and investment interest available to support commercialization and clinical adoption. This is the message I brought to both the diagnostics and tick biology subcommittees. I hope it resonates. Innovation is all for naught if we can’t find a way to bring those solutions to market and into clinical practice for the benefit of patients.
NASEM Workshop: Toward a Common Research Agenda in Infection-Associated Chronic Illnesses
In June, the National Academies of Science, Engineering and Medicine (NASEM) held a 2-day workshop that brought together researchers, policymakers, disease advocates and others to Washington, DC, to review the latest research on infection-associated chronic illness. Our team at Galaxy has been eagerly awaiting this event for many years as an update to a similar workshop held by the Institute of Medicine (now part of NASEM) back in 2003. Many of the pathogens implicated in chronic illnesses today were on the radar twenty years ago.
What has changed? Well, the research linking infections like borreliosis (e.g., Lyme disease) and bartonellosis (e.g., cat scratch disease) to persistent chronic illness has advanced significantly and is now validated and further bolstered by the research on long COVID. What struck me the most this year was the overlapping clinical and biological factors across infections and disease states. Many patients with MS, ME/CFS, chronic Lyme disease, and long COVID share non-specific symptoms and syndromic diagnostic labels, like POTS, EDS, MCAS, hypothyroidism and metabolic dysfunction. Meeting recordings are available online and a summary report is forthcoming.
CLA State of Lyme Disease Research
The Center for Lyme Action (CLA) released a report on the State of Lyme Disease Research authored by Nicole Bell, a respected advocate and now Chief Business Officer at Galaxy. We helped promote the CLA report at the International Lyme and Associated Disorders (ILADS) conference in Boston this Fall. Nicole Bell and CLA’s Bonnie Crater also shared the highlights of the report at a recent ILADS webinar. This policy report calls for a cure for Lyme and other tick-borne diseases by 2030 and presents a research summary clarifying the need for an annual research funding budget on the order of $500M – $1B per year to achieve this goal.
Our dedication to transforming healthcare with ultrasensitive direct detection for Bartonella, Borrelia and other emerging vector-borne diseases is more than a simple commitment to science – it’s our mission to ensure that doctors have the right tools and knowledge to ensure that their patients are receiving the right diagnosis. We believe that our testing solutions and technologies offer an important potential to revolutionize chronic disease diagnosis and care.
As we celebrate the holidays, we are reminded of why we do what we do and how valuable our partners and customers are to our mission. It truly takes a village to transform healthcare for good. We look forward to working alongside you to drive advocacy, collaboration, and transformation of clinical understanding regarding the role of infection in chronic illness.
Wishing you a prosperous New Year,
Amanda Elam, PhD
CEO/Cofounder
Galaxy Diagnostics, Inc.
Bush, J. C., et al. (2023). Viability and desiccation resistance of Bartonella henselae in biological and non-biological fluids: Evidence for pathogen environmental stability. Pathogens, 12(7), Article 950. https://doi.org/10.3390/pathogens12070950 https://pubmed.ncbi.nlm.nih.gov/37513797/
Thiel, N., et al. (2023). Risk factors for Bartonella seroreactivity among veterinary workers in the Pacific Northwest. Vector Borne and Zoonotic Diseases, 23(7), 356–363. https://doi.org/10.1089/vbz.2022.0060 https://pubmed.ncbi.nlm.nih.gov/37326985/
Offutt, A., & Breitschwerdt, E. B. (2023). Case report: Substantial improvement of autism spectrum disorder in a child with learning disabilities in conjunction with treatment for poly-microbial vector borne infections. Frontiers in Psychiatry, 14, Article 12055045. https://doi.org/fpsyt.2023.1205545 https://pubmed.ncbi.nlm.nih.gov/37663607/
Lathe, R., et al. (2023). Establishment of a consensus protocol to explore the brain pathobiome in patients with mild cognitive impairment and Alzheimer’s disease: Research outline and call for collaboration. Alzheimers & Dementia: The Journal of the Alzheimer’s Association, 19(11), 5209–5231. https://doi.org/10.1002/alz.13076 https://pubmed.ncbi.nlm.nih.gov/37283269/
Tick-Borne Disease Working Group. (2022). 2022 report to Congress. https://www.hhs.gov/sites/default/files/tbdwg-2022-report-to-congress.pdf
National Academies of Sciences, Engineering and Medicine. (2023, June 29-30). Toward a common research agenda in infection-associated chronic illnesses: A workshop to examine common, overlapping clinical and biological factors. https://www.nationalacademies.org/event/06-29-2023/toward-a-common-research-agenda-in-infection-associated-chronic-illnesses-a-workshop-to-examine-common-overlapping-clinical-and-biological-factors
Knobler, S. L., et al. (Eds.) (2004). The infectious etiology of chronic diseases: Defining the relationship, enhancing the research, and mitigating the effects [Workshop summary]. National Academies Press.
Center for Lyme Action. (2023, July). The state of Lyme Disease research in the United States. https://bmjb0c.a2cdn1.secureserver.net/wp-content/uploads/2023/07/State-of-Lyme-Disease-Research-CLA-Paper-FINAL-07-18-23-Clean-1.pdf
Center for Lyme Action. (2023, December 4). The state of Lyme Disease research and tick-borne disease-related legislative action. https://www.youtube.com/watch?v=vhJDG2Bh_Z0&t=2s