From the Health and Human Services website:

By Kristen Honey, PhD, PMP, and Daniel Desautels

The U.S. Department of Health and Human Services and the Steven & Alexandra Cohen Foundation (Cohen Foundation) has announced that the LymeX Diagnostics Prize received 52 Phase 1 submissions.

From May to August 2022, the first phase of this Lyme Innovation Accelerator competition called on experts to submit innovative detection methods that will advance Lyme disease diagnostics.

Hailing from a range of organizations—including academia, innovation centers, major diagnostics corporations, and startup labs—entrants submitted a breadth of proposed solutions for detecting active Lyme disease infections in people.

The ultimate goal of the multiphase competition is to nurture the development of diagnostics toward Food and Drug Administration review.

Although an estimated 476,000 Americans are diagnosed and treated for Lyme each year, there is no FDA-cleared test that can detect active infection. Early diagnosis of Lyme disease is critical: if left untreated, the debilitating disease can become harder to eradicate and can spread throughout the body.

By using an open innovation structure, the LymeX Diagnostics Prize is able to offer funding alongside access to technical assistance while fostering collaboration opportunities—which provides incentives to a diverse group of experts to come together and address an unmet patient need.

From adapting techniques such as radiology imaging, genomics sequencing, and microfluidics to translating approaches used in diagnosing other infectious diseases, including COVID-19, the concept papers that were submitted proposed a range of high-potential ideas.

Critical need for accurate Lyme testing

It is a priority for this administration to protect and expand Americans’ access to quality, affordable health care. The success of Phase 1 of the LymeX Diagnostics Prize competition has the potential to address Americans’ critical need for an accurate Lyme disease diagnostic test.

Phase 1 demonstrated that the competition’s open innovation model can accelerate scientific breakthroughs while fostering collaboration and partnerships.

A multidisciplinary group of technical reviewers and judges are evaluating submissions according to official Phase 1 evaluation criteria. Based on this evaluation, the judging panel will recommend up to 10 winners, who will each receive an equal share of the $1 million Phase 1 prize pool and an invitation to participate in a proposed Phase 2.

“We are thrilled by the wide range of solutions and look forward to working with the LymeX Diagnostics Prize’s community of collaborators to advance the next generation of Lyme disease diagnostics,” said Steven & Alexandra Cohen Foundation President Alexandra Cohen. “Through our $10 million pledge to the prize competition, we are committed to strengthening our public-private LymeX partnership with HHS.”

At the discretion of HHS and the Cohen Foundation, and subject to availability of future funding, at least one additional phase may follow Phase 2.

Future phases are expected to focus on clinical and nonclinical validation of diagnostic tests that detect active infection by Lyme-disease-causing bacteria, as well as readiness for regulatory submission and market entry. Thanks to a $10 million pledge to the LymeX Diagnostics Prize from the Cohen Foundation, $9 million in additional LymeX prizes are projected to be available in proposed future phases.

To learn more, visit LymeXDiagnosticsPrize.com.

About LymeX

The LymeX Diagnostics Prize is sponsored by the Lyme Innovation Accelerator, a partnership between the U.S. Department of Health and Human Services and the Steven & Alexandra Cohen Foundation. LymeX is the world’s largest public-private partnership for Lyme disease, fostering collaborative innovation among patients and advocates, academia, nonprofits, industry, and government.

About the Steven & Alexandra Cohen Foundation

The Steven & Alexandra Cohen Foundation is the largest private funder of Lyme and tick-borne disease research in the United States with over $75 million disbursed for groundbreaking studies in prevention, diagnostics, and treatment as well as building essential research infrastructure to catalyze innovation.