HHS and the Cohen Foundation Announce Phase 1 Winners in LymeX Diagnostics Prize

Transformative innovations are advancing the next generation of Lyme disease diagnostics

Today, the U.S. Department of Health and Human Services (HHS) and the Steven & Alexandra Cohen Foundation (Cohen Foundation) announced 10 Phase 1 winners in the LymeX Diagnostics Prize, a LymeX Innovation Accelerator (LymeX) competition to accelerate the development of Lyme disease diagnostics. Phase 1 called on scientific, technical, and clinical experts to submit innovative methods 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.

"The winning solutions demonstrate great potential to make transformative innovation a reality for so many Americans," said Assistant Secretary for Health Admiral Rachel L. Levine, M.D. "Through the LymeX Diagnostics Prize we are using open innovation to accelerate diagnostic breakthroughs, drive cross-sector collaboration, and put patients at the center of scientific discovery."

From May to August 2022, Phase 1 received 52 solutions for detecting active Lyme disease infections in people. Solutions incorporated techniques such as radiological imaging, genomics sequencing, and microfluidics. Submissions also leveraged and translated approaches used in diagnosing other infectious diseases, including COVID-19. Technical reviewers initially evaluated this highly competitive field, and then the competition judging panel assessed submissions according to official evaluation criteria.

"Early detection and treatment are essential in the fight against this debilitating disease. The Phase 1 winning solutions provide hope for a future in which anyone can quickly and easily get an accurate Lyme disease diagnosis," said Cohen Foundation President Alexandra Cohen. "We look forward to advancing the next generation of innovative Lyme disease diagnostics and providing the necessary structure for winners on their path to FDA review and approval."

HHS congratulates the Phase 1 winners, who will each receive $100,000 and an invitation to participate in a second phase, subject to the availability of future funding:

• BlueArc Biosciences Inc.Ultra-Sensitive Direct Diagnostic for Early Lyme Disease. A molecular diagnostic blood test for Lyme B. burgdorferi s.l. using innovative polymerase chain reaction (PCR) assay that targets biomarkers for increased accuracy using standard laboratory equipment.
• Drexel University College of Medicine.Glycoproteomic Approach to Lyme Disease Diagnostics. A small-volume serum test using glycan biomarkers to detect active Lyme disease infection, track treatment response, and distinguish between diseases with similar symptoms.
• George Mason University. Borrelia Derived, Sequence-Specific Novel Diagnostic Peptides. A urine direct test that targets absolutely specific protein molecules and would provide direct information about pathogen activity.
• HelixBind Inc.Ultra-Sensitive Direct Detection of Active Borrelia Infections. A test combining novel sample preparation and artificial nucleic acid detection to identify active infection in whole blood, synovial fluid, and cerebrospinal fluid.
• InBios International Inc.Early Lyme Diagnosis Using a Microarray Immunoassay with Machine Learning. An automated, quantified, array-based serum test using machine learning to improve sensitivity in categorizing specimens.
• Massachusetts General Hospital.Cell-free Target Capture Sequencing for the Diagnosis of Lyme Disease. A plasma test depleting human background material from samples and detecting low-abundance nucleic acid from tick-borne pathogens.
• Serimmune Inc.NGS-based Precision Serology for the Diagnosis of Tick-borne Disease. A universal multiplex serum test that incorporates patient-centric surveillance testing, population data, and machine learning to enhance understanding of tick-borne diseases.
• T2 Biosystems Inc.T2Lyme Panel Direct Detection of Active Lyme Disease. A whole blood test designed to directly detect Lyme disease-causing bacteria, providing results in three to five hours with higher accuracy.
• Tufts University.Antiphospholipid Antibodies for Tracking Lyme Disease After Treatment. A serum test targeting a unique antibody that would more accurately identify early infection and allow clinicians to optimize additional treatment.
• Virginia Tech.Detecting Release of Peptidoglycan for Direct Lyme Disease Diagnosis. A test using monoclonal antibodies in conjunction with immuno-PCR to detect a unique B. burgdorferi biomarker in multiple biofluids.

The Lyme-disease-causing bacterium is complex, and collaboration is vital to accelerating innovation in disease diagnostics. The current two-tier serological testing system to detect Lyme disease relies on the presence of antibodies and can only be used accurately four to six weeks after infection. The LymeX Diagnostics Prize's open innovation model is accelerating discovery and development by offering funding alongside exclusive access to key resources and collaboration opportunities-helping innovators take their solutions from concept to the healthcare market. 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.

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 and receive future updates, visit LymeXDiagnosticsPrize.com and subscribe to the competition newsletter.

About LymeX

The LymeX Diagnostics Prize is sponsored by the LymeX 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. As a component of a larger moonshot, LymeX is identifying, developing, and implementing advancements in Lyme disease care. In addition to accelerating next-generation diagnostics, LymeX is spearheading development of human-centered solutions and fostering breakthroughs in education and awareness. For more information, visit lyme-x.org.

About the U.S. Department of Health and Human Services

HHS enhances and protects the health and well-being of all Americans. HHS fulfills that mission by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. For more information, visit hhs.gov.

About the Steven & Alexandra Cohen Foundation

The Steven & Alexandra Cohen Foundation is committed to inspiring philanthropy and community service by creating awareness, offering guidance, and leading by example to show the world what giving can do. The Foundation's grants support nonprofit organizations based in the United States that either help people in need or solve complex problems. The 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. The Foundation also spearheads grassroots campaigns to encourage others to give. For more information, visit steveandalex.org

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