As part of the LymeX Diagnostics Prize, the U.S. Department of Health and Human Services (HHS) and the Steven & Alexandra Cohen Foundation (Cohen Foundation) have brought together experts with a diversity of perspectives and experiences to evaluate the Phase 1 submissions. The first phase of this LymeX Innovation Accelerator (LymeX) competition received 52 solutions for detecting active infections when submissions closed in August 2022. The ultimate goal of the multiphase competition is to nurture the development of diagnostics toward Food and Drug Administration review.
Early diagnosis of Lyme disease is critical. If left untreated, the debilitating disease can become harder to eradicate and spread throughout the body. The current diagnostic process — a two-tiered antibody testing algorithm 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.
The Lyme-disease-causing bacteria is uniquely complex, and collaboration is vital to accelerating innovation in disease diagnostics. From planning workshops to the multidisciplinary group of technical reviewers and judges, the LymeX Diagnostics Prize has brought together patients, advocates, academia, nonprofits, industry, and government to address this urgent patient need.
Meet the technical reviewers
A multidisciplinary group of technical reviewers first evaluated submissions according to official Phase 1 evaluation criteria. The LymeX Diagnostics Prize thanks the technical reviewers for contributing their time and expertise:
- Maria E. Aguero-Rosenfeld, M.D., Professor, Department of Pathology at NYU Grossman School of Medicine
- James Anthony, Ph.D., Project Officer at the Biomedical Advanced Research and Development Authority (BARDA)
- James Berger, M.S., M.T. (ASCP), S.B.B., Senior Blood and Tissue Policy Advisor, Office of Infectious Disease and HIV/AIDS Policy, Office of the Assistant Secretary for Health at HHS
- Jason Bobe, M.S., Founder, DIYbio.org
- Denise Bonilla, M.S., National Cattle Fever Tick Program Manager and Entomologist at the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service
- Arthur Chang, M.D., M.S., Chief Medical Officer, Division of Environmental Health Science and Practice at the National Center for Environmental Health/Agency for Toxic Substances and Disease Registry, Centers for Disease Control and Prevention (CDC)
- Matthew Davenport, Ph.D., Project Officer at HHS
- Laimonas Kelbauskas, M.S., Ph.D., Research Scientist at Arizona State University
- John Lee, Ph.D., Health Scientist at BARDA
- Matt Lewis, M.P.A., Global Chief Medical Analytics and Innovation Officer at Inizio Medical
- Robyn Nadolny, Ph.D., Biologist and Vector-Borne Disease Branch Chief, Army Public Health Center
- Lyle R. Petersen, M.D., M.P.H., Director, Division of Vector-Borne Diseases at the National Center for Emerging and Zoonotic Infectious Diseases, CDC
- Kathleen Quinn, M.S., Team Lead – Diagnostics at the Defense Threat Reduction Agency
- Mark Scheckelhoff, M.S., Ph.D., Project Officer at BARDA
- Timothy Sellati, Ph.D., Chief Scientific Officer at Global Lyme Alliance
- Samuel Shor, M.D., General Internist at Internal Medicine of Northern Virginia
- Leith States, M.D., M.P.H., Chief Medical Officer at the Office of the Assistant Secretary for Health, HHS
- Kristy Stoudt, M.S., Ph.D., Contracting Officer Technical Representative at BARDA
Meet the judging panel
Based upon the initial evaluation by technical reviewers, the judging panel assessed submissions according to official Phase 1 evaluation criteria. Based on the judging panel’s recommendation, HHS will award 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. The LymeX Diagnostics Prize plans to announce the winners in late fall 2022.
The LymeX Diagnostics Prize thanks the judges for contributing their time and expertise:
- Holly Ahern, M.S., M.T. (ASCP), Associate Professor of Microbiology at SUNY Adirondack
- Nadine Bowden, D.V.M., Ph.D., Program Officer for Lyme disease and other Borrelioses at the National Institute of Allergies and Infectious Diseases
- Christine Green, M.D., board certified family physician
- Adriana Marques, M.D., Chief of the Lyme Disease Studies Unit, Laboratory of Clinical Immunology and Microbiology at the National Institute of Allergy and Infectious Diseases, National Institutes of Health
- Paul S. Mead, M.D., M.P.H., Chief of the Bacterial Diseases Branch (BDB), Division of Vector-Borne Diseases at the National Center for Emerging and Zoonotic Infectious Diseases
- Jenny Rooke, Ph.D., Founder and Managing Director at Genoa Ventures
- Kristian Roth, Ph.D., Deputy Director, Division of Microbiology Devices, Office of In Vitro Diagnostics at the U.S. Food and Drug Administration
- Jinyu Shan, Ph.D, Chief Scientific Officer at Phelix Research & Development and a Research Fellow at University of Leicester
What comes next: Projected $9 million in prizes in proposed future phases
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.
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