2022: Year in Review

As we reflect on the year, we are grateful for the progress we have made together to build awareness about flea and tickborne infections. This year, we released exciting new test offerings for Lyme borreliosis and bartonellosis (cat scratch disease) that go beyond the limits of conventional detection, received CPT codes for our novel test offerings, supported FREE continuing medical education for providers, and participated in the Tickborne disease working group (details below).

It is with sincere appreciation to all our patients, clinicians, partners, collaborators, and advisors that we look forward to 2023 with a shared purpose of advancing diagnostics and clinical research for flea- and tickborne diseases.

 

Thank you for your important role in this partnership!

 

We rely on your support to fulfill our mission to provide better diagnostic tools for flea- and tickborne diseases. After another grueling pandemic year, support from our customers and supporters is more important than ever. How can you help?

Order our Testing – As a small lab, we run a tight business model and the pandemic has been rough. The best way to support our development and commercialization is to order testing and to recommend our testing services to providers and patients who will benefit.

Support our Research – Consider sponsoring case reports and studies on key disease associations.

Educate the Public – Help us build awareness about the risks of flea- and tickborne diseases by sharing resources with your community and medical providers.

2022 Galaxy Milestones

Lyme Nanotrap® Antigen test: Our strongest-performing direct test in a chronic disease population based on one year of post market data following the launch last year. The peer-reviewed published clinical utility study showed 100% sensitivity in patients with EM rash and 98% specificity, along with 41% positive rate in Lyme patients with persistent symptoms after treatment.

 

Bartonella Digital ePCR™:  Peer-reviewed publication of our clinical validation study in high-risk patients showed ddPCR sensitivity 10 times qPCR. BAPGM enrichment further enhances sensitivity of detection. This increased sensitivity is allowing doctors to confirm cases of current infections missed by antibody testing. Importantly, the digital PCR technology shows a strong basis for multiplexing as the digital PCR technology advances. We are excited to see the gains in sensitivity that this technology can provide in the coming years.

 

Insurance Reimbursements: We received proprietary CPT codes (required for insurance) for our three novel assays (Lyme Nanotrap, Bartonella Digital ePCR, and Bartonella ddPCR) along with the first set of reimbursements from private insurers. This news represents exciting progress as reimbursements reduce the out-of-pocket expense for patients and are critically important to making these tests more affordable and accessible.

 

Swamp Boy Story: We worked with a team of clinicians and advocates at Invisible International for two years to translate a compelling case study implicating Bartonella infection in sudden onset psychosis in a young male. This backstory as presented in this article written by medical writer Kris Newby is a wild read and one of most-read articles at NowThisNews in 2022. The story was also picked up by journalist Ross Douhat in an article he wrote for the New York Times. A great way to build disease awareness!

 

Continuing Medical Education: We are very grateful for the wonderful work of the sponsors and team at Invisible International in both building awareness and providing ACCME-/AAFP-accredited medical education about flea- and tickborne disease. The Montecalvo platform provides free CME for medical professionals. Galaxy cofounder Dr. Ed Breitschwerdt has provided 6 modules on Bartonellosis to guide providers on its history, emerging clinical importance, disease manifestations, and diagnostic best practices. We are very proud to contribute to the CME platform along with research partners and colleagues dedicated to advancing patient care in this area of emerging infectious disease.

 

TBDWG Service: It was a privilege to serve on two subcommittees for the Tickborne Disease Working Group in the third and last round of meetings and report writing in 2022. In the Diagnostics Subcommittee report, we documented a long list of innovations in the development pipeline, but there are serious bottlenecks in terms of research funding and barriers to commercialization and scale. In the Tick Ecology Subcommittee report, we documented similar issues related to the development and commercialization of insecticides, public health education, and other prevention measures. These issues have been identified and documented thanks to the leadership and generous support of the US Office of the Secretary for Health and the Steve and Alexandra Cohen Foundation.

 

We look forward to working with you in 2023!

Further Reading

Magni, R. et al. (2015). Application of Nanotrap technology for high sensitivity measurement of urinary outer surface protein A carboxyl-terminus domain in early stage Lyme borreliosis. Journal of Translational Medicine, 13, 346. https://doi.org/10.1186/s12967-015-0701-z https://pubmed.ncbi.nlm.nih.gov/26537892/

Maggi, R. G. et al. (2020). Development and validation of a droplet digital PCR assay for the detection and quantification of Bartonella species within human clinical samples. Journal of Microbiological Methods, 176, 106022. https://doi.org/j.mimet.2020.106022 https://pubmed.ncbi.nlm.nih.gov/32795640/