4 things everyone needs to know about Lyme disease

4 things everyone needs to know about Lyme disease

Just launched: LymeX Diagnostics Prize, a prize competition to accelerate the development of Lyme disease diagnostics.

This week, the U.S. Department of Health and Human Services (HHS) and the Steven & Alexandra Cohen Foundation launched the LymeX Diagnostics Prize, a prize competition to accelerate the development of Lyme disease diagnostics. Phase 1 calls on scientific, technical, and clinical experts to submit innovative methods for detecting active Lyme disease infections in people. The multiyear competition, designed by Luminary Labs through a NASA Tournament Lab contract, will nurture the development of solutions toward Food and Drug Administration review.

An estimated 476,000 Americans are diagnosed and treated for Lyme disease each year, but the true number of infections is unknown. The genome of Lyme disease-causing spirochetes has been described as the most complex of all bacteria, and developing direct diagnostic tests is extremely difficult. With the LymeX Diagnostics Prize bringing together patients, advocates, academia, nonprofits, philanthropy, industry, and government to answer this critical need, here are four things to understand about the growing problem.

1. Lyme disease is the most common vector-borne disease in the United States.

A critical need for diagnostics innovation.

From plague to malaria, vector-borne diseases — infections transmitted by vectors, such as mosquitoes, ticks, and flies — have been around for thousands of years. Together, they account for 17% of all infectious diseases and cause more than 700,000 deaths annually worldwide.

Lyme disease is by far the leading vector-borne disease in America. Other vector-borne diseases reported in the United States — including Zika, West Nile virus, dengue, and Rocky Mountain spotted fever — typically appear in limited outbreaks or have drastically fewer cases.

2. FDA-cleared tests cannot detect cases of active infection.

There is no FDA-cleared test for active Lyme disease infection

The current diagnostic process is significantly limited; it relies on a characteristic bulls-eye skin rash called erythema migrans or the CDC-recommended two-tiered antibody testing algorithm. Up to 30% of patients will never present the rash, and research suggests that medical staff may disproportionately miss it on patients of color. The two-tier antibody testing system — originally developed in 1994 for disease surveillance, not as a stand-alone diagnostic test — relies on the presence of antibodies and can only be used accurately four to six weeks after infection.

Early diagnosis of Lyme disease is critical. If left untreated, the debilitating disease can become harder to eradicate and spread throughout the body. Better diagnostics yield better information, which will yield better decisions and responses.

3. Lyme disease is already prevalent across the United States — and continues to spread.

Lyme disease is everywhere

Lyme disease is not a modern phenomenon: Research shows that the Lyme disease bacterium has been present in North America for at least 60,000 years. But since 1995, reported cases have tripled as climate change increases the geographic and seasonal distribution of ticks across the United States. Ecological transformations — particularly the loss of natural deer predators — have likewise allowed infected ticks to thrive in suburban habitats.

Our understanding of current prevalence relies on reported cases, but active surveillance requires active data — and the gap in testing capabilities is clear. If experts can measure the problem and understand how big it is, they are one step closer to solving it.

4. Innovation in diagnostic testing is possible now.

The need is urgent — and now is the time for new detection methods

The last few years have taught us the importance of diagnostics innovation — and now it’s time to bring that momentum to Lyme disease. The LymeX Diagnostics Prize will set a new bar for innovation in disease diagnostics, incentivizing transformative partnerships and catalyzing additional investment.

With the geographic range and seasonal distribution of mosquitoes, ticks, and flies only continuing to increase, vector-borne diseases remain a growing threat to Americans. Spurring innovation in Lyme disease diagnostics will support critical advancements in testing for other diseases — leading to better options in treatment and improving outcomes for millions of patients.

Learn more about the LymeX Diagnostics Prize

Register to attend the June 16 virtual information session and submit a concept paper by August 8. The Phase 1 winners will receive an equal share of the $1 million Phase 1 prize pool and be invited to participate in a planned Phase 2. Visit the LymeX Diagnostics Prize website to learn more and sign up for competition updates.