The U.S. Department of Health and Human Services (HHS) and the Steven & Alexandra Cohen Foundation have announced five Phase 2 winners in the LymeX Diagnostics Prize, a competition to accelerate the development of Lyme disease diagnostics.

From January to September 2023, 10 teams participated in a virtual accelerator designed to help them refine their concepts for detecting active Lyme disease infections in people. The goal of this multiphase LymeX Innovation Accelerator (LymeX) competition is to nurture the development of diagnostics toward Food and Drug Administration review.

“With Lyme disease cases approaching an estimated 500,000 annually, Americans need an FDA-approved diagnostic that can accurately test for active infections. HHS is working with the Steven & Alexandra Cohen Foundation through the LymeX Innovation Accelerator public-private partnership to accelerate crucial innovations in industry and academia that could improve treatment and care for this debilitating disease.”
— Rear Admiral Michael F. Iademarco, M.D., MPH, Deputy Assistant Secretary for Science and Medicine

Meet the winners in the $2 million Phase 2

The Phase 2 virtual accelerator offered access to virtual learning, mentorship, biorepository subject matter expertise, and networking opportunities designed to help the cohort progress toward FDA review. Phase 2 awarded $2 million in prizes based on the teams’ interim and final submissions.

“As we congratulate our Phase 2 winners, we are also proud to support the next steps in advancing these tests toward FDA review. This award marks a major milestone in the fight against Lyme disease—and hope for so many Americans at risk of infection.”
— Alex Cohen, President of the Steven & Alexandra Cohen Foundation

Read more about the Phase 2 winners, who will each be awarded $265,000:

• BlueArc Biosciences Inc. (La Jolla, California). 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 (Philadelphia, Pennsylvania). A small-volume serum test using glycan biomarkers to detect active Lyme disease infection and track treatment response.
• HelixBind Inc. (Marlborough, Massachusetts). An ultrasensitive, automated test to detect and identify active Lyme borreliosis, direct from blood, in three hours.
• T2 Biosystems Inc. (Lexington, Massachusetts). A whole blood test designed to directly detect Lyme disease-causing bacteria, providing results in three to five hours with higher accuracy.
• Virginia Tech (Blacksburg, Virginia). A test using monoclonal antibodies in conjunction with both immuno-PCR and lateral flow to rapidly detect a unique B. burgdorferi biomarker in blood and urine.

Each team’s final concept paper described how they are developing their diagnostic, included clinical and patient input, and proposed a roadmap from laboratory to market that includes FDA review.

The competition judging panel—composed of experts in areas such as vector-borne disease biology, clinical and technology translation, patient experience and advocacy, and diagnostic science and technology—evaluated eligible submissions according to official Phase 2 evaluation criteria.

HHS lays out ambitious national strategy

The Phase 2 winner announcement comes as part of a broader release of the HHS National Public Health Strategy to Prevent and Control Vector-Borne Diseases in People (VBD National Strategy).

Co-led by the HHS Office of the Assistant Secretary for Health and Centers for Disease Control and Prevention, the VBD National Strategy identifies and describes federal priorities to detect, prevent, respond to, and control diseases and conditions caused by vectors in the United States.

Vectors—including mosquitoes, ticks, fleas, and lice—can spread pathogens that are major causes of death and illness worldwide; diseases spread by vectors include Lyme disease, Zika virus, West Nile Virus, dengue, malaria, plague, Rocky Mountain Spotted Fever, and alpha-gal syndrome.

What comes next in the multiphase competition

Thanks to a $10 million pledge to the LymeX Diagnostics Prize from the Steven & Alexandra Cohen Foundation, $7 million in additional LymeX prizes are projected to be available in proposed future phases.

SOURCE: LymeX